USP 797 Pharmacy Blog

USP 797 Consulting on New Prefab Pharmacy Cleanrooms

2011-11-13T07:15:00.000-08:00

USP 797 Consulting Firm Selected to Provide USP 797 Consulting on New Prefab Pharmacy Cleanrooms

USP797.org, Inc., the only consulting company in the United States focused exclusively on USP 797, is pleased to announce that it was recently hired to consult on a new, USP 797 compliant, prefab pharmacy clean rooms.

The pharmacy, which will be compounding sterile products in separate chemotherapy compounding and non-chemotherapy compounding rooms, require consulting on whether the pharmacy plans and proposed pharmacy equipment, meet current USP 797 guidelines. Well known pharmacy design architect William N. Bernstein, AIA leads the consulting assignment. Amongst the areas to be reviewed: selection of USP 797 compliant pharmacy equipment, revisions of HVAC pressurization relationships, and additional USP 797 planning suggestions regarding appropriate pharmacy dimensions, flow and materials.

About USP 797:

USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.

Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797summary, biosafety cabinet class, and usp 797 regulations.

For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:

USP797.org, Inc.
1201 Broadway - #803, New York, NY 10001
T: 212.463.0800
E: info@usp797.org
W: www.usp797.org

USP 797 Revisions Webinar

2011-11-13T07:09:00.000-08:00

Webinar on USP 797 Revisions, see http://www.usp.org/education/pe/courses.html?locale1=EN&aaa=EN&course_id=9&country%5B%5D=1&languag%5B%5D=1&Search=Submit+Query

About USP 797:

USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.

Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797 summary, biosafety cabinet class, and usp 797 regulations.

For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:

USP797.org, Inc.
1201 Broadway - #803, New York, NY 10001
T: 212.463.0800
E: info@usp797.org
W: www.usp797.org

USP 797 Consulting Firm Selected to Provide USP 797 Consulting on New Pharmacies in New York Metro Area

2011-10-02T13:06:00.001-07:00

USP797.org, Inc., the only consulting company in the United States focused exclusively on USP 797, is pleased to announce that it was recently hired to consult on a new, USP 797 compliant pharmacy being constructed in the New York Metro region.

The pharmacy, which will be compounding sterile products in separate chemotherapy compounding and non-chemotherapy compounding rooms, require consulting on whether the pharmacy plans and proposed pharmacy equipment, meet current USP 797 guidelines. Well known pharmacy design architect William N. Bernstein, AIA leads the consulting assignment. Amongst the areas to be reviewed: selection of USP 797 compliant pharmacy equipment, revisions of HVAC pressurization relationships, and additional USP 797 planning suggestions regarding appropriate pharmacy dimensions, flow and materials.

About USP 797:

USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.

Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797 summary, biosafety cabinet class, and usp 797 regulations.

For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:

USP797.org, Inc.
1201 Broadway - #803, New York, NY 10001
T: 212.463.0800
E: info@usp797.org
W: www.usp797.org
USP 797 on Twitter: www.twitter.com/usp797
USP 797 Blog: usp797org.blogspot.com

USP 797 Pre-Occupancy Inspection

2011-07-03T08:10:00.000-07:00

USP 797 Consulting Firm Selected to Provide USP 797 Pre-Occupancy Inspection on New Pharmacies in New York

USP797.org, Inc., the only consulting company in the United States focused exclusively on USP 797, is pleased to announce that it recently completed a USP 797 consulting assignment on a new hospital-based compounding pharmacy in New York.

The pharmacy, which will be compounding sterile products in separate chemotherapy compounding and non-chemotherapy compounding rooms, required a pre-occupancy inspection to review the construction of the pharmacy, and advise of any areas that did not meet USP 797, so the hospital could rectify those conditions prior to occupancy. Well known pharmacy design architect William N. Bernstein, AIA led the consulting assignment. The pre-occupancy survey revealed a number of areas where improvements in the project needed to be made to meet USP 797 guidelines. Amongst the areas identified: selection of USP 797 compliant pharmacy equipment, revisions of HVAC pressurization relationships, and additional USP 797 planning suggestions regarding appropriate pharmacy dimensions, flow and materials.

About USP 797:

USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.

Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797 summary, biosafety cabinet class, and usp 797 regulations.

For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:

USP797.org, Inc.
1201 Broadway - 803, New York, NY 10001
T: 212.463.0800
E: info@usp797.org
W: www.usp797.org

USP 797 Learning Boosted by Virtual Clean Room

2011-07-03T07:46:00.000-07:00

According to an article in Pharmacy Practice News, by David Bronstein, Purdue University’s College of Pharmacy has developed a three-dimensional (3-D) virtual clean room to teach its students how to comply with USP Chapter 797 requirements for sterile IV preparations.“The primary goal of the program,“ according to the article, “the first of its kind in pharmacy education, according to the instructors—was to enhance the students’ ability to confidently follow the sterile-compounding requirements. Another important aim was for students to gain a better understanding of the extent to which a typical hospital is at risk for making errors during IV drug preparation.“

The success of the teaching program was also reported in the American Journal of Pharmaceutical Education (2011;75:7).

To read more about this virtual USP 797 cleanroom, go to http://www.pharmacypracticenews.com/ViewArticle.aspx?d=Policy&d_id=51&i=June+2011&i_id=738&a_id=17304

About USP 797:

USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.

Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797summary, biosafety cabinet class, and usp 797 regulations.

For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:

USP797.org, Inc.
1201 Broadway - #803, New York, NY 10001
T: 212.463.0800
E: info@usp797.org
W: www.usp797.org

USP 797 Seminars

2010-06-23T11:32:00.000-07:00

Tuesday, 07/20/10

9:00am-4:00pm

USP <797>, Environmental Sampling, and Data Interpretation

Four Points by Sheraton
Boston Logan International Airport
407 Squire Rd.
Revere, MA 02151

Note: Parking is complimentary

REG: US $199 (Early Registration: $99 if registered by July 16, 2010)

This seminar is highly recommended for anyone who needs to implement a USP <797> sampling program or has questions about the USP <797> analysis offered by EMLab P&K. The course instructor is Dr. Joseph Manfrida, EMLab P&K's lead USP <797> analyst. Dr. Manfrida will provide information regarding the background and purpose of USP <797> and will discuss designing and executing a USP <797> sampling regimen. For more information about the course, please download the registration form at http://www.emlab.com/m/media/RAP_boston_072010.pdf or contact EMLab P&K.

Contact: EMLab P&K
www.emlabpk.com

Thursday, 07/22/10

9:00am-4:00pm

USP <797>, Environmental Sampling, and Data Interpretation

Doubletree Hotel
455 Washington Blvd.
Jersey City, NJ 07310

Note: Parking will be validated

REG: US $199 (Early Registration: $99 if registered by July 16, 2010)

This seminar is highly recommended for anyone who needs to implement a USP <797> sampling program or has questions about the USP <797> analysis offered by EMLab P&K. The course instructor is Dr. Joseph Manfrida, EMLab P&K's lead USP <797> analyst. Dr. Manfrida will provide information regarding the background and purpose of USP <797> and will discuss designing and executing a USP <797> sampling regimen. For more information about the course, please download the registration form at http://www.emlab.com/m/media/RAP_jerseycity_072210.pdf or contact EMLab P&K.

Contact: EMLab P&K
www.emlabpk.com

Friday, 07/23/10

8:00am-3:00pm

USP <797>, Environmental Sampling, and Data Interpretation

Courtyard Philadelphia Airport
8900 Bartram Ave.
Philadelphia, PA 19153

Note: Parking is complimentary

REG: US $199 (Early Registration: $99 if registered by July 16, 2010)

This seminar is highly recommended for anyone who needs to implement a USP <797> sampling program or has questions about the USP <797> analysis offered by EMLab P&K. The course instructor is Dr. Joseph Manfrida, EMLab P&K's lead USP <797> analyst. Dr. Manfrida will provide information regarding the background and purpose of USP <797> and will discuss designing and executing a USP <797> sampling regimen. For more information about the course, please download the registration form at http://www.emlab.com/m/media/RAP_philadelphia_072310.pdf or contact EMLab P&K.

Contact: EMLab P&K
www.emlabpk.com

EMLab P&K
THE PROVEN LEADER
1150 Bayhill Drive, Suite 100
San Bruno, CA 94066
Tel 650.742.8142 | EFax 650.829.5852
www.emlabpk.com

Did you know that EMLab P&K sells a full line of IAQ products?
Buy equipment and supplies online now at http://www.emlab.com/store
Performing USP 797 compliance testing? EMLab P&K can help.
Check out USP 797 services at http://www.emlab.com/USP_797

Water System Biofil Testing by Aemtek

2010-05-08T13:20:00.000-07:00

[Press Release] 2010.5.8

Aemtek offers in-depth training on water system biofilm
All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems. In spite of this overt absence of nutrients, microorganisms growing as biofilms can flourish within these systems and lead to undesirable contamination of facility processes and their products. In order to limit the bacteria that may be in the water, one has to understand and control the development of biofilms in the water system. Aemtek offers a two-day course that is designed to provide an in-depth look at how biofilm affects all aspects of water systems, including design, operation, validation, monitoring, sanitization, and excursion investigations. Right and wrong approaches will be discussed along with tips on how to minimize excursions as well as how to perform contamination investigations with example case studies to reinforce this learning.
The course will be taught by renowned industry expert, Dr. TERI C. (“T.C.”) SOLI. Dr. Soli has been consulting for 15 years with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, and validation. He is Vice-Chair of the USP Pharmaceutical Waters Expert Committee and has authored several ISPE and PDA book chapters, papers, and USP Monographs and Chapter revisions, including his complete rewrite of USP’s “water bible”, Chapter <1231>.
This comprehensive course is titled "EVERYTHING YOU NEED TO KNOW ABOUT WATER SYSTEM BIOFILM" and will be held on JUNE 16TH — 17TH, 2010 at AEMTEK TRAINING ROOM, 46309 WARM SPRINGS BLVD., FREMONT, CA 94539. For more information, visit http://www.aemtek.com/training or email training@aemtek.com.

About Aemtek
Aemtek, Inc. is an accredited microbiological testing and research laboratory providing services to multiple industries, including environmental, food, pharmaceutical and compounding pharmacies. We specialize in detection, identification and analysis of fungi and bacteria, using morphological, physiological, biochemical, and molecular methods. Aemtek has repeatedly demonstrated competence and integrity throughout all of our interactions with the regulatory agencies and our customers. Aemtek’s accurate, fast, and reliable laboratory services save you both time and money. Our commitment to scientific excellence, quality service, and advanced technology assures our clients that their projects are done right the first time, every time, on time. Contact information: AEMTEK, INC., 46309 Warm Springs Blvd., Fremont, CA 94539, Phone: 510-979-1979, Fax: 510-668-1980 Email: lab@aemtek.com, web: www.aemtek.com.

USP 797 Environmental Sampling, and Data Interpretation

2010-04-13T10:38:00.000-07:00

Friday, 05/21/10

9:00am-4:00pm

USP <797>, Environmental Sampling, and Data Interpretation

EMLab P&K San Bruno

1150 Bayhill Drive, Suite #100

San Bruno, CA 94066

Note: Parking is complimentary

REG: US $199 (Early Registration: $99 if registered by May 7, 2010)

This seminar is highly recommended for anyone who needs to implement a USP <797> sampling program or has questions about the USP <797> analysis offered by EMLab P&K. The course instructor is Dr. Joseph Manfrida, EMLab P&K's lead USP <797> analyst. Dr. Manfrida will provide information regarding the background and purpose of USP <797> and will discuss designing and executing a USP <797> sampling regimen. For more information about the course, please contact EMLab P&K.

Contact: EMLab P&K

EMLab P&K
THE PROVEN LEADER
1150 Bayhill Drive, Suite 100
San Bruno, CA 94066
Tel 650.742.8142 | EFax 650.829.5852
www.emlabpk.com

The Cleanroom Supply Connection

2010-04-04T19:53:00.000-07:00

The Cleanroom Supply Connection (www.cleanroomsupplyconnection.com) is now listed on the vendor page of the usp797 website: www.usp797.org.

Aerobiology Laboratory Associates

2010-04-04T19:52:00.000-07:00

Aerobiology Laboratory Associates (www.aerobiology.net) is now listed on the vendor page of the usp797 website: www.usp797.org.

USP 797 Consulting Firm Consults on New Pharmacies in New York

2010-04-04T19:49:00.000-07:00

USP797.org, Inc., the only consulting company in the United States focused exclusively on USP 797, is pleased to announce that it recently completed a USP 797 consulting assignment on two new sterile compounding pharmacies in New York.

The two pharmacies, which will be compounding sterile products in separate chemotherapy compounding and non-chemotherapy compounding rooms, required consulting on whether their pharmacy plans and proposed pharmacy equipment, met current USP 797 guidelines. Well known pharmacy design architect William N. Bernstein, AIA led the consulting assignment. The analysis revealed that there were a number of areas where improvements in the project could be made to meet USP 797 guidelines. Amongst the areas identified: selection of USP 797 compliant pharmacy equipment, revisions of HVAC pressurization relationships, and additional USP 797 planning suggestions regarding appropriate pharmacy dimensions, flow and materials.

About USP797.org, Inc.:

USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.

About USP797.org:

Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797summary, biosafety cabinet class, and usp 797 regulations.

For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:

usp797.org. inc.
59 West 19th Street- 6A, New York, NY 10011
T: 212.463.0800
F: 212.463.9898
E: info@usp797.org
W: www.usp797.org

New USP 797 Postings on Twitter

2010-03-20T05:04:00.000-07:00

New USP 797 Twitter Account

USP797.org, Inc. is pleased to announce that a new Twitter account has been estbalished devoted exclusively to USP 797 news. Follow USP 797 on Twitter at www.twitter.com/usp797.

About USP 797:

USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.

Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797 summary, biosafety cabinet class, and usp 797 regulations.

For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:

USP797.org, Inc.
59 West 19th Street – 6a, New York, NY 10011
T: 212.463.0800
F: 212.463.9898
E: info@usp797.org
W: www.usp797.org

USP 797 Consulting Completes New USP 797 Consulting Assignment

2010-02-28T12:40:00.000-08:00

For Immediate Release (02/28/10)

USP 797 Consulting Firm Selected to Provide USP797 Consulting on New Pharmacies in New York

USP797.org, Inc., the only consulting company in the United States focused exclusively on USP 797, is pleased to announce that it recently completed a USP 797 consulting assignment on two new sterile compounding pharmacies in New York.

The two pharmacies, which will be compounding sterile products in separate chemotherapy compounding and non-chemotherapy compounding rooms, required consulting on whether their pharmacy plans and proposed pharmacy equipment, met current USP 797 guidelines. Well known pharmacy design architect William N. Bernstein, AIA led the consulting assignment. The analysis revealed that there were a number of areas where improvements in the project could be made to meet USP 797 guidelines. Amongst the areas identified: selection of USP 797 compliant pharmacy equipment, revisions of HVAC pressurization relationships, and additional USP 797 planning suggestions regarding appropriate pharmacy dimensions, flow and materials.

About USP 797:

USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.

Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797 summary, biosafety cabinet class, and usp 797 regulations.

For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:

USP797.org, Inc.
59 West 19th Street – 6a, New York, NY 10011
T: 212.463.0800
F: 212.463.9898
E: info@usp797.org
W: www.usp797.org

Pharmacy Consultants USP797.org, Inc. Featured in List of USP 797 Consultants

2010-01-01T16:23:00.000-08:00

USP797.org, Inc., a nationally known, multidisciplinary pharmacy consulting company specializing exclusively in usp 797 compliant facilities, is pleased to announce that the firm has been featured in a list of usp 797 consultants in the November 2009 issue of Pharmacy Purchasing & Products.

About USP797.org:

USP797.org is recognized as the most comprehensive and authoritative source for usp 797 news, usp 797 education, usp 797 consultants and usp 797 products. The website was created and is maintained by the pharmacy consulting company USP797.org, Inc. --- an interdisciplinary consulting company focused on all aspects of usp 797 implementation and compliance. Amongst the topics covered on this usp 797 website are: sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usps 797, usp 797 summary, biosafety cabinet class, usp 797 regulations, and usp 797 clean rooms.

For more information about usp 797, contact:

USP797.org, Inc.
59 West 19th Street - 6A, New York, NY 10011
Tel: 212.463.0800
Fax: 212.463.9898
Email: info@usp797.org
www.usp797.org

New USP 797 Article Written by Eric Kastango Published in Pharmacy Purchaisng & Products Magazine

2009-11-08T11:48:00.000-08:00

An excellent article on usp 797, written by Eric Kastango has been published in the October issue of Pharmacy Purchasing and Products (www.pppmag.com).

Entitled “The Top 10 Gaps in USP Chapter Compliance”, it lists the areas that Mr. Kastango has found most likely to be missed in the course of usp 797 compliance.

The 10 usp 797 gaps discussed, include understanding of the usp 797 regulations, usp 797 facility design issues, usp 797 compliant procedures and operating standards, usp 797 training, and usp 797 testing and certification.

To read this article, go to: http://www.pppmag.com/pp-p-cleanrooms-compounding-2009/the-top-10-gaps-in-usp-chapter-compliance

USP 797 Compliance in 2009

2009-10-19T11:19:00.000-07:00

New Article on USP 797 Compliance Published

Bernstein & Associates, Architects is pleased to announce the publication of a new article about USP 797 compliance. The article was published on USP 797 (www.usp797.org), the website focused on design, construction and operation of USP 797 compliant pharmacies.

The article discusses the following:

- An interesting survey of USP 797 compliance in the United States in 2009 was recently published in Pharmacy Purchasing & Products magazine (www.pppmag.com).
- The survey looks at various areas of USP 797 compliance.
- It begins with results of the most basic question: how many directors of pharmacy have read the USP 97 regulation
- Partial or full pharmacy compliance with USP 797 has also grown
- Full compliance with USP 797 is measured differently
- The approach of regulatory bodies towards USP 797
- State boards of pharmacy and USP 797 compliance
- JCAHO and USP 797 compliance
- Hospitals reporting a patient incident involving a compounding error during the past five years
- Continuing improvement in USP 797 compliance in pharmacies in the United States, as well as increased focus on USP 797 compliance by state pharmacy boards and JCAHO.

About the Author:

William N. Bernstein, LEED®AP, AIA is the principal of Bernstein & Associates, Architects (www.bernarch.com) and president of Equipment Planning, Inc. (www.equipmentplanning.org). This architecture firm and equipment planning firm are well-known for pharmacy planning, pharmacy design and pharmacy architecture, including a sub-specialty in usp 797 compliant pharmacy design and construction. These pharmacy consulting firms have designed and equipment planned over twenty new pharmacies, pharmacy renovations, and pharmacy relocations in the past five years. The firm's principal --- William N. Bernstein, LEED®AP, AIA --- is a well known pharmacy architect and pharmacy equipment planner. He has written extensively on pharmacy design and pharmacy construction including usp 797 compliant pharmacies. Mr. Bernstein's pharmacy design articles can be found on www.pharmacydesign.org, and his usp 797 articles can be found on the usp 797 website www.usp797.org.

For more information about pharmacy planning, pharmacy design and pharmacy construction, contact Bernstein & Associates, Architects at:

Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A, NY, NY 10011
T: 212.463.8200
F: 212.463.9898
E: info@bernarch.com
www.bernarch.com

For more information about pharmacy equipment planning, and pharmacy automation equipment specifications and planning, contact Equipment Planning, Inc. at:

Equipment Planning, Inc.
59 West 19th Street - 6A, NY, NY 10011
T: 212.463.08200
F: 212.463.9898
E: info@equipmentplanning.org
www.equipmentplanning.org

USP 797 Newsletter (October 2009)

2009-10-13T03:57:00.000-07:00

usp797.org newsletter

www.usp797.org is a privately-owned website developed to aid understanding of the USP 797 regulation

October 2009

IN THIS ISSUE

usp797.org - Vendor News
- "Forward Thinking Pharmacy Design Boosts Patient Safety, Efficiency and Aesthetics"
- "CT International’s Bonric Manufacturing Facility in Malaysia is Pleased to Announce That it Has Been Certified ISO 14001"
- "EMLab P&K Supports Clients After Recent Flooding"

USP797 Seminars Being Offered

usp797.org - Questions and Answers

usp797.org - vendors
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usp797.org - Vendor News

10/08/09: "Forward Thinking Pharmacy Design Boosts Patient Safety, Efficiency and Aesthetics"

A new hospital pharmacy design, for the Santa Barbara Cottage Hospital, has many goals, but the number one goal, from the beginning, was always clear: patient safety. The director of the pharmacy, Allan Cohen, PhD --- who signs all of his emails with the phrase “Patient Safety is Contagious – Pass It On!” --- and the Assistant Director, Sergio Castro, made sure that patient safety played a central role in the myriad decisions made in the planning and design process for the new pharmacy.

For full text of the article, go to: http://usp797.org/VendorNews-PharmacyDesignBoostsPatientSafety.htm

10/05/09: "CT International’s Bonric Manufacturing Facility in Malaysia is Pleased to Announce That it Has Been Certified ISO 14001"

The ISO 14001 standard requires that an organization put in place and implement a series of practices and procedures that, when taken together, result in an environmental management system (EMS).

For full text of the article, go to: http://www.usp797.org/VendorNews-CTI-BonricFacilityCertifiedISO14001.htm

10/02/09: "EMLab P&K Supports Clients After Recent Flooding"

You are probably aware of the recent flooding that took place in Georgia. In fact, many of EMLab P&K's clients are working hard to assist those in Georgia and the Southeast region. Flooding increases the need for environmental testing due to potential health risks associated with contaminated water from sewage and various waterborne agents. As a result, residents and property owners must deal with the potential for bacterial contamination, mold growth, sewage contamination and other environmental health concerns caused by flooding and water damage.

For full text of the article, go to: http://usp797.org/VendorNews-EMlabSupportsClients.htm

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USP797 Seminars Being Offered

Aseptic Processing and Compliance Tools for USP <797>
Fundamentals of Bioassay Practices
For more info go to: http://www.usp797.org/Seminars.htm
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usp797.org - Questions and Answers (latest Q&A posted on site)

RJLG Question 15: I have a question regarding the preparation of chemotherapy. I have a negative pressure glove box that is vented to the outside. It is currently in the same room as my positive pressure glove box. If I have verification from the manufacturer that the glove box does not need to be in a clean room--do I need to place the chemo glove box in a negative pressure room? Could I place it in a separate room without negative pressure. If my room does not have negative pressure--where is the appropriate area to store my chemo meds? I would appreciate any information you can send.

RJLG Answer 15: First, your glove box which is used to prepare hazardous drugs must meet the definition of a compounding aseptic isolator (CAI) or compounding aseptic containment isolator (CACI) and must be physically separated from other preparation areas (i.e., in a different room). If the CAI or CACI meets the conditions of the “Placement of Primary Engineering Controls” section of USP797 that allow usage outside of an ISO Class 7 buffer area or clean room, the room must be negative pressure (minimum 0.01 inch water column and 12 air changes per hour). If only a low volume of hazardous drugs are prepared and a closed system transfer device (CSTD) is used within the CAI or CACI, the room does not need to be negative pressure.

Regarding hazardous drug storage, please refer to RJLG Questions 12 and 14 in this Q&A section of the USP797.org website.
Answer provided as a courtesy to USP797.org by Matthew Zock of the RJ Lee Group, Inc. (RJLG). Note: Neither RJLG nor USP797.org assumes any liability for the use or interpretation of this information. Please con consult your pharmacy consultant prior to taking any actions in your pharmacy.

For more USP 797 Questions and Answers, go to: http://www.usp797.org/Questions_and_Answers.htm
--------------------------------------------------------------------------------
usp797.org Vendors

Architects
Bernstein & Associates, Architects

Analytical Testing
Aemtek, Inc.
Burgh & Schoenenberger Associates, Inc.
EM Lab P&K
EMSL Analytical Inc.
Pathcon Laboratories

Cleaning Products / Contamination Control
Acute Care Pharmaceuticals
Attentus Medical Sales, Inc.
Berkshire Corporation
Blue Thunder Technologies, Inc.
Connecticut Clean Room Corporation
Contec, Inc.
CT International
Decon Labs Inc.
Dycem's CleanZone
FHP LP
Lymtech Scientific
Techniglove International

Cleanroom Design/Build Companies:
Clean Room Technologies, Corp.
Connecticut Clean Room Corporation
TAC Americas
TCA

Compliance Action Plans
Clinical IQ, LLC
Global Quality Alliance, LLC
Lasco Services
Quality Solutions, LLC
RJ Lee Group, Inc.

Contamination Control
Building Remediation Sciences

Environmental Monitoring
AES-Chemunex, Inc.
Biotest
Building Health Check/Pure Air Control Services, Inc.
Controlled Environment Testing Association
ENV Services, Inc.
Lighthouse Worldwide Solutions
RJ Lee Group, Inc.
Technical Safety Services, Inc.

Equipment Planning
Equipment Planning, Inc.

National USP 797 Testing Provider
Medical Technology Associates, Inc.

Project Management
Empire Projects, Inc.

Software
Simplifi 797

Testing & Certification
Certco, Inc.
ENV Services, Inc.
Pure Air Control Services, Inc.
Technical Safety Services, Inc.

USP 797 Related Products
CriticalPoint, LLC
EMSL Analytical Inc.
Esco Technologies
Germfree Laboratories Incorporated
Isotech Design
RJ Lee Group, Inc.
Trion, Inc. Air Purification Systems

USP 797 Related Organizations
American Society of Health System Pharmacists
United States Pharmacopeia
usp797.org
-------------------------------------------------------------------------------

USP797.org, Inc. (www.USP797.org) is a privately-owned website developed to aid public understanding of the USP 797 regulation developed by U.S. Pharmacopoeia, and its JCAHO-mandated schedule for implementation
--------------------------------------------------------------------------------
Contact Info for USP797.org:

USP797.org, inc.
59 West 19th Street, Suite # 6A, New York, NY 10011
T : 212-463-0800
F : 212-463-9898
E: info@usp797.org
W: www.usp797.org

USP797.org Newsletter (July 2009 Edition)

2009-09-04T16:26:00.000-07:00

Below is a summary of the USP797.org Newsletter (a usp 797 newsletter)

usp797.org - Vendor News

07/28/09: Architect Selected to Design New State-of-the-Art Pharmacy in California

Bernstein & Associates, Architects (www.bernarch.com) is pleased to announce it has been selected to provide architectural design and equipment planning services for a new hospital pharmacy in Santa Barbara, CA.

For full text of the article, go to: http://usp797.org/NewsRelease-ArchitectSelectedforNewPharmacy-0709.htm

07/28/09: Connecticut Clean Room Corporation Expands Product Line to Include USP 797, Safety and Additional Industrial Products

Connecticut Clean Room Corporation, a manufacturer, distributor and converter of special products that meet all critical manufacturing, industrial and sanitary standards has recently expanded its product line to include USP 797, safety and additional industrial products.

For full text of the article, go to: http://usp797.org/NewsRelease-CTCleanroom-0709.htm

--------------------------------------------------------------------------------

USP797 Seminars Being Offered

Aseptic Processing and Compliance Tools for USP <797>
Fundamentals of Bioassay Practices
For more info go to: http://www.usp797.org/Seminars.htm

--------------------------------------------------------------------------------
usp797.org - Questions and Answers (latest Q&A posted on site)

RJLG Question 17: Chapter <797> states that “hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure”. I work in a hospital with a separate negative pressure chemo room adjacent to a positive pressure ante room. We use a separate refrigerator for chemotherapy drugs and it is only accessed by staff that are involved in the preparation and distribution of these drugs. However, this refrigerator is too large to store in our negative pressure chemo room and would adversely impact our air quality. Therefore, we store this refrigerator in a separate storage room. Since the concern of volatilization of hazardous drugs is at room temperature and these drugs are refrigerated, is this an acceptable plan?

RJLG Answer 17: Hazardous drug storage in a separate negative pressure room is preferred, but not required by USP797. It sounds as if your hazardous drugs are stored separately from other inventory and access is restricted only to authorized personnel. As long as your storage is in a manner to prevent contamination and personnel exposure, your plan may be acceptable. Hazardous drug storage must be in accordance with USP797, OSHA, and other applicable guidelines and recommendations. Your site-specific policies & procedures and hazardous drug safety plan must include conditions for storage. Also see RJLG Question 12 in this Q&A section of the USP797.org website for more information.
Answer provided as a courtesy to USP797.org by Matthew Zock of the RJ Lee Group, Inc. (RJLG). Note: Neither RJLG nor USP797.org assumes any liability for the use or interpretation of this information. Please con consult your pharmacy consultant prior to taking any actions in your pharmacy.

For more USP 797 Questions and Answers, go to: http://www.usp797.org/Questions_and_Answers.htm
--------------------------------------------------------------------------------
usp797.org Vendors

Pharmacy Architects
Bernstein & Associates, Architects (www.ernarch.com)

Pharmacy Construction Project Management
Empire Projects, Inc. (www.empireprojects.com)

Analytical Testing
Aemtek, Inc.
EDLab
EM Lab P&K
EMSL Analytical Inc.
Pathcon Laboratories

Cleaning Products / Contamination Control
Acute Care Pharmaceuticals
Attentus Medical Sales, Inc.
Berkshire Corporation
Blue Thunder Technologies, Inc.
Connecticut Clean Room Corporation
Contec, Inc.
Decon Labs Inc.
Dycem's CleanZone
FHP LP
Lymtech Scientific
Medical Specialties Distributors, LLC (MSD)
Techniglove International

Cleanroom Design/Build Companies:
Clean Room Technologies, Corp.
Connecticut Clean Room Corporation
TAC Americas
TCA

Compliance Action Plans
Clinical IQ, LLC
Global Quality Alliance, LLC
Lasco Services
Quality Solutions, LLC
RJ Lee Group, Inc.

Contamination Control
Building Remediation Sciences

Environmental Monitoring
AES-Chemunex, Inc.
Biotest
Building Health Check/Pure Air Control Services, Inc.
Controlled Environment Testing Association
ENV Services, Inc.
Lighthouse Worldwide Solutions
RJ Lee Group, Inc.
Technical Safety Services, Inc.

Equipment Planning
Equipment Planning, Inc. (www.equipmentplanning.org)

National USP 797 Testing Provider
Medical Technology Associates, Inc.

Software
Simplifi 797

Testing & Certification
Certco, Inc.
ENV Services, Inc.
Pure Air Control Services, Inc.
Technical Safety Services, Inc.

USP 797 Related Products
The Baker Company
CriticalPoint, LLC
EMSL Analytical Inc.
Esco Technologies
Germfree Laboratories Incorporated
Isotech Design
RJ Lee Group, Inc.
Trion, Inc. Air Purification Systems

USP 797 Related Publications
Pharmacy Design (www.pharmacydesign.org)
usp 797 (www.usp797.org)

New Article on Mail Order Pharmacy Design Published

2009-09-01T15:00:00.001-07:00

Bernstein & Associates, Architects is pleased to announce the publication of a new article about mail order pharmacy design. The article was published on Pharmacy Design (www.pharmacydesign.org), the website focused on pharmacy design.

The article discusses the following pharmacy design concepts for a mail order pharmacy:

- an aesthetically pleasing pharmacy environment, combined with a focus on pharmacy workflow and pharmacy functionality
- creation of pharmacy “pod” workstations
- pharmacy pod storage
- pharmacy pod touch screen computer
- use of pharmacy counting machines, located close to each pod for increased prescription workflow
- an efficient pharmacy storage and pharmacy shelving system to house drug overstock
- provision of excess pharmacy shelving to accommodate company and stock volume growth
- custom controlled substance cabinets disguised to look identical to regular cabinets to prevent theft in the event of a break in. These cabinets are located in a central, clear area for constant monitoring and easy access.
- provision for future addition of pharmacy automation technology, as well as the addition of new pharmacist/technician teams.

To view this article: go to www.pharmacydesign.org

About Bernstein & Associates, Architects: Founded in 1990, *Bernstein & Assoc., Architects - PLLC* is an award-winning architectural firm specializing in healthcare and laboratories, with a sub-specialty in the design and construction of USP 797-compliant pharmacy facilities. Over the last three years, the firm has designed over (20) usp 797-compliant pharmacies.

For more information about pharmacy design and construction, please contact:
William N. Bernstein, AIA
Principal
Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A New York, NY 10011
T: 212.463.8200
F: 212.463.9898
E: info@bernarch.com
W: www.bernarch.com

Hazardous Drug Storage in an USP 797 Compliant Environment

2009-08-02T09:44:00.000-07:00

Questions and Answers on USP 797

RJLG Question 17: Chapter <797> states that “hazardous drugs shall be stored separately from other inventory in a manner to prevent contamination and personnel exposure”. I work in a hospital with a separate negative pressure chemo room adjacent to a positive pressure ante room. We use a separate refrigerator for chemotherapy drugs and it is only accessed by staff that are involved in the preparation and distribution of these drugs. However, this refrigerator is too large to store in our negative pressure chemo room and would adversely impact our air quality. Therefore, we store this refrigerator in a separate storage room. Since the concern of volatilization of hazardous drugs is at room temperature and these drugs are refrigerated, is this an acceptable plan?

RJLG Answer 17: Hazardous drug storage in a separate negative pressure room is preferred, but not required by USP797. It sounds as if your hazardous drugs are stored separately from other inventory and access is restricted only to authorized personnel. As long as your storage is in a manner to prevent contamination and personnel exposure, your plan may be acceptable.
Hazardous drug storage must be in accordance with USP797, OSHA, and other applicable guidelines and recommendations. Your site-specific policies & procedures and hazardous drug safety plan must include conditions for storage. Also see RJLG Question 12 in this Q&A section of the USP797.org website for more information.

Answer provided as a courtesty to usp797.org, inc. by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that usp797.org, inc. is not responsible for this answer.

Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:

Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com

Pharmacy Design Website Features Latest Information for the Hospital Pharmacy and Clinical Pharmacy.

2009-08-02T09:41:00.000-07:00

For Immediate Release (08/01/09)

Looking to design a pharmacy, purchase pharmacy equipment, or hire a pharmacy architect? Then you may be interested in a new pharmacy website which focuses on the all of the components that go into designing, building and maintaining a state-of-the-art pharmacy.

An important component of today’s pharmacy is pharmacy automation. This is one area that Pharmacy Design (www.pharmacydesign.org) features, including the latest pharmacy equipment and pharmacy machines.

Another area of focus is trends in pharmacy architecture, pharmacy layout design, and pharmacy interior design. As an example, a recent article published on the site, written by well-known pharmacy designer William N. Bernstein, AIA --- of the prominent pharmacy design group Bernstein & Associates, Architects --- explores how design for pharmacy can contribute to the efficiency and success of the pharmacy operation.

An additional area of focus is usp 797 design.

For further information about pharmacies design, visit the pharmacy design website:
Pharmacy Design at www.pharmacydesign.org.

usp 797 consulting services

2009-06-19T20:22:00.000-07:00

www.usp797.org, inc. is a privately owned company, committed to public education and consulting on the usp 797 regulation.

We have been at the forefront of the usp797 regulation since 2005. Our website --- www.usp797.org – was launched in 2005, and is updated regularly.

usp797.org, inc. provides consulting to pharmacy clients, looking to upgrade or maintain their conformance to all of the latest usp 797 guidelines. Our consulting team has been built utilizing only the most knowledgeable and experienced professionals in the pharmaceutical industry, all of whom have a significant sub-specialty in the area of usp 797 theory and implementation.

Amongst the usp 797 consulting services offered by www.usp797.org, inc. are: architecture, engineering, construction, project management, analytical testing, recommendation of cleanroom products and contamination control, design/build, compliance action plans, environmental monitoring, software, and testing & certification.

Please note: usp797.org, inc. supports the important work of the USP, but has no affiliation with USP.

For further information about usp 797 consulting, please contact:

usp797.org, inc.
59 West 19th St. - 6A, NY, NY 10011
Telephone : 212-463-0800
Fax : 212-463-9898
Email : info@usp797.org

New Pharmacy Design Website Now Online

2009-06-12T20:13:00.001-07:00

For Immediate Release (06/12/09)

Pharmacy Design (www.pharmacydesign.org) is a comprehensive new pharmacy website that is now online. The site will be useful to pharmacists, pharmacy vendors, pharmacy administrators, pharmacy managers, and pharmacy students.

Pharmacy Design is a comprehensive source for pharmacy owners, or managers, looking to upgrade their facility to a state-of-the-art pharmacy environment.

Why Pharmacy Design?

Are you interested in upgrading your pharmacy (either a hospital pharmacy or community health center pharmacy or retail pharmacy) to create a more functional, efficient, and appealing pharmacy environment? A facility that is also focused on patient and staff safety?

Pharmacy Design offers facility managers, pharmacy managers, pharmacy purchasing agents, and pharmacy owners a comprehensive directory for all products and services needed to design, build, equip, and manage a state-of-the-art pharmacy.

What you fill find on Pharmacy Design: Pharmacy Planning and Pharmacy Design Services, Pharmacy Construction Service, Pharmacy Project Management Services, Pharmacy Products, Pharmacy Equipment, Pharmacy Furniture, and Pharmacy Software.

For more information about pharmacy design and construction, including usp 797 compliant pharmacy design, visit Pharmacy Design (www.pharmacydesign.org).

New Article Published on Pharmacy Design

2009-06-11T05:33:00.001-07:00

For Immediate Release (06/10/09)

New Article Published on Trends in Pharmacy Design and Operations

Bernstein & Associates, Architects is pleased to announce the publication of an article on recent trends in pharmacy design and pharmacy planning.

The article was published in the June 2009 edition of Pharmacy Design, the pharmacy design and pharmacy planning website, located at www.pharmacydesign.org.

The article discusses the latest trends in pharmacy design in the following areas:
- Pharmacy design has been undergoing dramatic changes in recent years
- A main trend has been the need to modernize and automate the production, packaging, distribution, and provision of drugs, particularly of prescription drugs, which have to be monitored and secured at all times.
- Clients looking to design a pharmacy will want to be cognizant of these trends.
- The movement towards pharmacy automation has been spurred by a number of factors
- The new electronic systems mean fewer medication errors and tighter security, not to mention more reliably safe drugs.
- Successful pharmacy plans from now on
- Clean rooms in pharmacies
- USP 797 for pharmacies
- automated drug management
- Pharmacy automation equipment within the pharmacy
- Swisslog PillPick
- McKesson ROBOT-Rx
- Pharmacy automation equipment connecting the pharmacy to other hospital departments
- Pyxis Medstation
- Bedside pharmacy dispensers
- Pneumatic tube systems in the pharmacy
- Future of the retail pharmacy
- Latest trends in retail pharmacy interior design

About Bernstein & Associates, Architects:

Bernstein & Associates, Architects has specialized in healthcare and lab design and construction since the firm's founding in 1990. This architecture firm is well-known for pharmacy planning, pharmacy design and pharmacy architecture, including a sub-specialty in usp 797 compliant pharmacy design and construction. The firm has designed over twenty new pharmacies, pharmacy renovations, and pharmacy relocations in the past five years. The firm is featured on the pharmacy design website, www.pharmacydesign.org, and the usp 797 website, www.usp797.org. The firm's principal --- William N. Bernstein, LEED®AP, AIA --- is a well known pharmacy architect. He has written extensively on pharmacy design and pharmacy construction including usp 797 compliant pharmacies. Mr. Bernstein's pharmacy design articles can be found on www.pharmacydesign.org, and his usp 797 articles can be found on the usp 797 website www.usp797.org.

For more information about healthcare and hospital design and construction, including pharmacy design and construction, contact Bernstein & Associates, Architects at:

Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A, NY, NY 10011
T: 212.463.8200
F: 212.463.9898
E: info@bernarch.com
www.bernarch.com
NEW YORK - HARFTFORD - PRINCETON

New Article Published on Greening the Hospitals Environment

2009-04-25T03:56:00.000-07:00

For Immediate Release (04/24/09)

Bernstein & Associates, Architects is pleased to announce the publication of a new article on greening the Hospital environment.

The article has been published in the May 2009 edition of Hospital Newspaper.

The article discusses opportunities to introduce green or sustainable design principles into a Hospital environment. The article references the LEED for Hospitals Green Building Rating System, as well as the Green Guide for Healthcare (GGHC). The principles discussed can be used to create sustainable Hospital design. The article includes discussion of the following areas: Sustainable Sites for Hospitals, Water Efficiency for Hospitals, Energy & Atmosphere for Hospitals, Materials & Resources for Hospitals, Environmental Quality for Hospitals, and Innovation & Design Process for Hospitals.

The article was written by the firm’s principle, a well-known expert in green hospital design, William N. Bernstein, LEED®AP, AIA.

About Bernstein & Associates, Architects: Founded in 1990, this company is an award-winning architectural firm specializing in sustainable hospital design and construction. The firm takes pride in providing the highest level of sustainable hospital design work, with additional expertise, energy saving measures for hospitals, cost reduction strategies for hospitals, hospital safety and patient safety.

For more information about green design for hospitals, please contact:
William N. Bernstein, LEED®AP, AIA
Principal - Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A New York, NY 10011
Office: 212.463.8200 - Fax: 212.463.9898
Email: info@bernarch.com
www.bernarch.com

Architect Selected to Provide Pharmacy Design Consulting on New USP 797 Compliant Pharmacy in Santa Barbara

2009-04-11T16:10:00.000-07:00

For Immediate Release (04/07/09)

Bernstein & Associates, Architects, is pleased that it has been selected to provide pharmacy design consulting for a new hospital in Santa Barbara. Services will include pharmacy programming, pharmacy adjacency diagrams, pharmacy flow diagrams, pharmacy equipment planning, and usp 797 pharmacy design.

The pharmacy project is a complete new pharmacy. The project includes all new iso 7 anteroom, iso 7 hazardous compounding room, and iso 7 non-hazardous compounding room. The facility is a state-of-the-art pharmacy that includes the latest pharmacy automation equipment.

About Bernstein & Associates, Architects:

Bernstein & Associates, Architects has specialized in healthcare and lab design and construction since the firm's founding in 1990. This architecture firm is well-known for pharmacy planning, pharmacy design and pharmacy construction, including usp 797 compliant pharmacy design and construction. The firm's principal --- William N. Bernstein, AIA --- is a well known architect of pharmacies. He has written extensively on pharmacy design and construction including usp 797 compliant pharmacies. Mr. Bernstein's usp 797 articles can be found on the usp 797 website http://www.usp797.org/.

For more information about healthcare and hospital design and construction, including pharmacy design and construction, contact Bernstein & Associates, Architects at:

Bernstein & Associates, Architects - PLLC
New York:
59 West 19th Street - 6A, New York, NY 10011
T: 212.463.8200
F: 212.463.9898
Hartford:
100 Pearl St. - 14th Floor, Hartford, CT 06103
T: 860-616-2200
F: 860-616-0018
E: info@bernarch.com
W: www.bernarch.com

USP 797 Newsletter (February 2009 edition)

2009-02-14T08:02:00.001-08:00

This is a summary of the February 2009 edition of the USP 797 Newsletter:
(produced by the privately-owned website www.usp797.org)
usp797.org - Vendor News
"EMSL analytical offers analysis for USP 797 samples", 01/14/09
"EMSL Analytical, a leading provider of laboratory services, recently announced they have begun to analyze samples for USP 797. Issued by the US Pharmacopoeia (USP), USP 797 regulations provide a standard for all pharmacies that prepare ‘compounded sterile preparations’ (CSPs). Most pharmacies must comply with this regulation and many hospitals that operate pharmacies meeting the same criteria are also affected..."
For the full article go to: http://usp797.org/VendorNews-EMSLAnalyticalOffersAnalysisforUSP797Samples.htm
"New Article on Design of Pharmacy to Conform with USP 797 (2008 version)", 01/31/09
"Bernstein & Associates, Architects is pleased to announce the publication of a new article about design of pharmacies to conform to the 2008 version of USP 797. The article has been published in the February 2009 edition of Hospital Newspaper. The article discussed the latest edition of USP 797, and how pharmacists and pharmacy managers should plan, design and construct their pharmacies to conform to USP 797..."
For the full article go to: http://usp797.org/VendorNews-DesignofaUSP797CompliantPharmacy.htm
________________________________________
USP797 Seminars Being Offered
• Aseptic Processing and Compliance Tools for USP <797>
• Practical Application of USP's General Chapter <797>
For more info go to: http://www.usp797.org/Seminars.htm
________________________________________
usp797.org - Questions and Answers (latest Q&A posted on site)
• RJLG Question 12: If chemotherapy medications are stored in the negative pressure cleanroom, how are refrigerated chemotherapy meds supposed to be stored since refrigerators should not be placed in the clean room? Do we have to build a separate negative pressure area for the refrigerator?
• RJLG Answer 12: Although a separate negative pressure room for bulk storage of all hazardous drugs would be ideal, storage in a negative pressure room is recommended by USP797 but not a current requirement.
All hazardous drugs must be stored separately from other inventory. Hazardous drugs should only be stored in the negative pressure buffer room if they are removed from their cartons and decontaminated in the ante area using appropriate procedures and personal protective equipment, and if the stored quantities are required for supporting your compounding operation. Excessive or bulk storage in the buffer room should be avoided.
Regarding your separate refrigerator for refrigerated hazardous drugs, USP797 states, “Placement of devices in ante areas and buffer areas is dictated by their effect on the designated environmental quality of atmospheres and surfaces, which shall be verified by monitoring.”
Answer provided as a courtesy to USP797.org by Matthew Zock of the RJ Lee Group, Inc. (RJLG). Note: Neither RJLG nor USP797.org assumes any liability for the use or interpretation of this information. Please consult your pharmacy consultant prior to taking any actions in your pharmacy.
For more USP 797 Questions and Answers, go to: http://www.usp797.org/Questions_and_Answers.htm
________________________________________
usp797.org Vendors
Architects:
Bernstein & Associates, Architects
Project Management:
Empire Projects, Inc.
Analytical Testing:
EM Lab P&K
EMSL Analytical Inc.
Cleaning Products / Contamination Control:
Acute Care Pharmaceuticals
Attentus Medical Sales, Inc.
Berkshire Corporation
Blue Thunder Technologies, Inc.
Contec, Inc.
Decon Labs Inc.
Dycem's CleanZone
Lymtech Scientific
Medical Specialties Distributors, LLC(MSD)
Techniglove International
Cleanroom Design/Build Companies:
TAC Americas
TCA
Compliance Action Plans:
Clinical IQ, LLC
Global Quality Alliance, LLC
Lasco Services
Quality Solutions, LLC
RJ Lee Group, Inc.
Environmental Monitoring:
AES-Chemunex, Inc.
Biotest
Controlled Environment Testing Association
Lighthouse Worldwide Solutions
RJ Lee Group, Inc.
Technical Safety Services, Inc.
Software:
Simplifi 797
Testing & Certification
Aemtek, Inc.
Certco, Inc.
Technical Safety Services, Inc.
USP 797 Related Products:
The Baker Company
CriticalPoint, LLC
EMSL Analytical Inc.
Esco Technologies
Germfree LaboratoriesIncorporated
Isotech Design
RJ Lee Group, Inc.
Trion, Inc. Air Purification Systems
www.usp797.org is a privately-owned website.
For more information about usp 797, go to the usp 797 website: www.usp797.org. Or go to the USP website itself at www.usp.org.

Storage of Chemotherapy Medications

2009-01-31T13:28:00.000-08:00

* RJLG Question 12: If chemotherapy medications are stored in the negative pressure cleanroom, how are refrigerated chemotherapy meds supposed to be stored since refrigerators should not be placed in the clean room? Do we have to build a separate negative pressure area for the refrigerator?

* RJLG Answer 12: Although a separate negative pressure room for bulk storage of all hazardous drugs would be ideal, storage in a negative pressure room is recommended by USP797 but not a current requirement.

All hazardous drugs must be stored separately from other inventory. Hazardous drugs should only be stored in the negative pressure buffer room if they are removed from their cartons and decontaminated in the ante area using appropriate procedures and personal protective equipment, and if the stored quantities are required for supporting your compounding operation. Excessive or bulk storage in the buffer room should be avoided.

Regarding your separate refrigerator for refrigerated hazardous drugs, USP797 states, “Placement of devices in ante areas and buffer areas is dictated by their effect on the designated environmental quality of atmospheres and surfaces, which shall be verified by monitoring.”

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

*

Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:

Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com

What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org

Purchase of Air Sampling Equipment and Performance of ISO Air Testing

2009-01-29T18:54:00.000-08:00

RJLG Question 11: Is it appropriate to purchase air sampling equipment and perform our own ISO air testing for both viable and particle samples in a hospital setting?

RJLG Answer 11: In short, simply purchasing equipment and attempting to perform these tasks may not, and likely will not be appropriate. Your USP797 viable and nonviable environmental testing programs require personnel with a great deal of education, training, experience, and in some cases licensure and certification. There are some tasks associated with these programs that must only be performed by knowledgeable, qualified, and competent personnel using specialized equipment.
If your facility is considering handling these programs internally, I strongly urge a complete investigation into all necessary requirements and responsibilities. There are many qualified third-party firms available to provide services at reasonable costs for your USP797-compliant environmental testing programs such as microbial environmental sampling and laboratory analysis, clean room testing and certification, and certification and repair of biological safety cabinets, laminar airflow workbenches, and other bio-safety equipment.

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:

Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com

For additional USP 797 Questions and Answers, go to: www.usp797.org.
What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software

New Article on Design of Pharmacy to Conform with USP 797 (2008 version)

2009-01-23T07:39:00.000-08:00

For Immediate Release (01/31/09)

Bernstein & Associates, Architects is pleased to announce the publication of a new article about design of pharmacies to conform to the 2008 version of USP 797.

The article has been published in the February 2009 edition of Hospital Newspaper.

The article discussed the latest edition of USP 797, and how pharmacists and pharmacy managers should plan, design and construct their pharmacies to conform to USP 797.

About USP 797: USP 797 is a far-reaching regulation that governs a wide range of pharmacy policies and procedures. It is designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals. Issued by U.S. Pharmacopoeia (USP), the regulation governs any pharmacy that prepares "compounded sterile preparations" (CSPs). Many pharmacies fit this description. Moreover, many large hospitals have several pharmacies--a main one and several satellite pharmacies--that will be affected. A good source of information about USP 797 is the website www.usp797.org, which includes commonly asked USP 797 questions and answers by USP 797 industry consultants.

About Bernstein & Associates, Architects: Founded in 1990, this company is an award-winning architectural firm specializing in healthcare and laboratories, with a sub-specialty in the design and construction of USP 797-compliant pharmacy facilities. Over the last three years, Bernstein & Associates, Architects has designed over (20) USP 797-compliant pharmacies. The firm currently has four USP 797 compliant pharmacies in design or construction, including the new cancer center pharmacy at Roswell Park Cancer Institute.

For more information about pharmacy design and construction, please contact:
William N. Bernstein, AIA
Principal - Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A New York, NY 10011
Office: 212.463.8200 - Fax: 212.463.9898
Email: info@bernarch.com
www.bernarch.com

EMSL analytical offers analysis for USP 797 samples

2009-01-19T19:47:00.000-08:00

For Immediate Release (01/14/09)

EMSL analytical offers analysis for USP 797 samples

EMSL Analytical, a leading provider of laboratory services, recently announced they have begun to analyze samples for USP 797. Issued by the US Pharmacopoeia (USP), USP 797 regulations provide a standard for all pharmacies that prepare ‘compounded sterile preparations’ (CSPs). Most pharmacies must comply with this regulation and many hospitals that operate pharmacies meeting the same criteria are also affected.

When compounding is conducted within a facility, a gap analysis should be performed in order to determine what the compliance action plan will be. In many cases, regular air as well as surface samples are necessary in order to analyze samples for any microbial contamination (i.e., fungal or bacterial presence whether viable or non-viable).

According to the USP 797 protocols, ‘a critical area must prove to meet ISO 5 classification at least once per six-month period. The frequency of determining the cleanliness class of supporting areas is also at least once per six months as recommended by USP and/or whenever renovations occur’.

When sampling for bacterial contamination, it is suggested that Tryptic Soy Agar (TSA) or comparable media be utilized. To sample for fungal contamination, it is recommended that Malt Extract Agar (MEA) or comparable media be used while testing.

“EMSL Analytical, Inc. has established a reputation for providing the highest quality analytical services in many industries and now EMSL is providing USP 797 samples with the same level of service that you’ve come to expect from EMSL,” reported Ben Sublasky, National Director of Client Services for EMSL Analytical, Inc. “We are proud to announce that EMSL is now accepting USP 797 samples,” continued Mr. Sublasky.

Can a biological safety cabinet (BSC) and a laminar flow hood be in the same ISO 7 room that meets all other USP 797 requirements (ante-room etc.).

2009-01-14T19:34:00.000-08:00

Questions and Answers on USP 797

RJLG Question 10: I have a question concerning the use of two different style hoods in the same area.
1. Can a biological safety cabinet (BSC) and a laminar flow hood be in the same ISO 7 room that meets all other USP 797 requirements (ante-room etc.). The BSC would not be used for hazardous products and is not vented to the outside air, but could be used short dated IV products (with exp2. If the answer to question 1 is yes is there a specific room arrangement? (i.e. the two hoods can be next to each other in the same plane vs. opposite each other, minimum distance apart, etc)

RJLG Answer 10:
Your policies & procedures for maintaining and working with your primary engineering controls (PECs) will be determined by scope (such as hazardous drug handling, etc.) and CSP microbial contamination risk levels. For non-hazardous drug compounding, any PECs such as laminar air flow workbenches (LAFWs), biological safety cabinets (BSCs), or other approved devices may be used to provide ISO Class 5 environments at your critical areas (direct compounding areas).

USP797 states that it is the responsibility of the compounding facility that all sources of ISO Class 5 environments (PECs such as LAFWs and BSCs) are properly located, operated, maintained, monitored, and verified. USP797 does not provide specific guidelines for room arrangements. PECs must be placed in the ISO Class 7 buffer area or clean room such that other PECs, supply-air diffusers, return air vents, doors, or other objects do not adversely impact the ISO Class 5 environments.

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:

Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com

New USP 797 Newsletter Introduced into Pharmacy Community

2009-01-14T19:19:00.000-08:00

A new usp 797 newsletter has been published by usp797.org. The initial issue was published in January 2009, and included press releases by usp 797 vendors (Bernstein & Associates, Architects, and RJLG), a sample usp 797 question and answer (concerning the use of two different style hoods in the same area), and a list of current usp 797 vendors. To subscribe to the usp 797 newsletter, send a request to info@usp797.org, with contact info and "request usp 797 newsletter" in email subject.

Storage of Refrigerator in Anteroom

2009-01-10T20:34:00.000-08:00

RJLG Question 9: Is it acceptable to store a refrigerator in the anteroom under any circumstance? The only answer I find in the chapter is “Placement of non-essential items within buffer and ante areas is determined by the impact on environmental quality as verified by monitoring.” Is there a more straightforward answer to this question? Did I miss the answer? We need a refrigerator in our anteroom to store thawed premixed bags but don’t want to purchase if the answer is a definite no. Thank you for your assistance with this question.

RJLG Answer 9: Placement of a refrigerator in your anteroom is acceptable if it is necessary for your compounding process and if it does not negatively impact environmental quality as per your viable and non-viable environmental sampling program. Use should be solely for the purposes of necessary tasks carried out in your controlled air environments.
Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:

Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com

What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software

Just-in-Time Hospital Project Management Services

2008-12-30T12:43:00.000-08:00

As the economy slows, and construction budgets and schedules are cut, clients may wish to consider Just-in-Time Hospital Project Management.

Unlike conventional Hospital Project Management services --- which start at the beginning of the project and conclude at the close-out ---
Just-in-Time Hospital Project Management is essentially an a la carte program for introducing hospital project management services at what are often crisis points in the life of a construction project.

The most common target of Just-in-Time Hospital Project Management is a project that is in trouble, as an example: a project that is over-budget, missing critical project deadlines and/or where construction team dynamics have deteriorated and need to be reconstituted to allow the team to function more effectively.

The most common insertion points for Just-in-Time Hospital Project Management are as follows:
- site selection
- programming
- design
- construction bid and award
- construction phase
- post construction

The most common Just-in-Time Hospital Project Management services fall into one or more of these areas:
- Cost: Cost Reduction, Cost Control, and Cost Monitoring
- Schedule: Schedule Reduction, Schedule Control, Schedule Monitoring
- Approvals: Expediting approval at the Planning Department, Building Department, Fire Department and/or State Health Department
- Close Out: Punchlist, Close Out Procedures and Documents, Commissioning, Financial Reconciliation/Resolution

For more information about Just-in-Time Hospital Project Management, please contact hospital project management consultants and hospital owner's representatives, Empire Projects, Inc.:

William N. Bernstein, PMI, AIA -
President
Empire Projects, Inc.
(Hospital Project Management Consultants and Owner's Representatives)59 West 19th Street -
New York, NY 10011
Phone: 212-463-0800
Fax: 212-463-9898
Email: info@empireprojects.com
www.empireprojects.com

New Program to Reduce Hospital Construction Costs in 2009

2008-12-29T14:58:00.000-08:00

For Immediate Release

With a greater need than ever to cut hospital costs, more and more hospital clients have asked well-known hospital project management firm, Empire Projects, Inc, a simple question: "How Can We Reduce Construction Costs in 2009?"

In response, the firm has developed a concise Construction Cost Reduction Program for clients looking to reduce their hospital capital costs for construction in 2009.

The cost control program is set up to value engineer projects in detail, at (5) critical project stages: programming, schematic design, construction documents, construction bidding, and construction.

The program can be utilized for all (5) critical project phases, or can be employed at just one or more of the phases.

Potential hospital construction cost savings are usually a minimum of 5% of construction cost, and can exceed 20% in certain cases.

The construction cost savings generated through this program greatly exceed the fees charged by EPI to implement it. In addition, the value engineering process creates leaner and better projects.

For more information on how this program can help control and reduce your hospital construction costs in 2009, please contact:

William N. Bernstein, AIA -
President
Empire Projects, Inc.
(Hospital Project Management and Owner's Representative Services for Design and Construction Projects)59 West 19th Street -
New York, NY 10011
Phone: 212-463-0800 I
Fax: 212-463-9898 I
Email: info@empireprojects.com
www.empireprojects.com

Negative Pressure Rooms Required in Low Volume Hazardous Compounding Rooms

2008-12-27T15:24:00.000-08:00

* RJLG Question 8: We are a small home infusion pharmacy. Approximately 2% of our patient base receives chemotherapy medications (primarily 5FU). Do we need a negative pressure room if: we compound/mix in a BSC, maintain a “safety zone” around the BSC within the clean room and utilize the PhaSeal product line when compounding?

* RJLG Answer 8: The Hazardous Drugs as CSPs section of USP797 allows low volume hazardous drug compounding in a non-negative pressure buffer or clean room if two tiers of containment are used, e.g., using a closed-system transfer device (CSTD) within a biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI). This is not an exemption from training and personal protective equipment (PPE) requirements, or recommended environmental sampling.

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

***************
Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:

Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com

*********************
For more information about USP 797, visit the USP 797 website: www.usp797.org.

Surface Sampling Inside a CACI

2008-12-27T15:23:00.001-08:00

Questions and Answers on USP 797

* RJLG Question 7: If a CACI is used as the PEC (The gloves used are part of the equipment) is gloved fingertip sampling required? Is surface sampling required inside a CACI? If so how frequently?

* RJLG Answer 7:

All compounding personnel must undergo performance evaluations including gloved fingertip sampling. Your site-specific standard operating procedures should be modified for CACI use. Periodic surface sampling is required in all ISO-classified environments including a CACI.

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

*

Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:

Matthew Zock
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
mzock@rjlg.com
*********************
For more information about USP 797, visit the USP 797 website: www.usp797.org.

Hospital Safety Website

2008-12-27T15:03:00.000-08:00

I wanted to post about a new hospital safety website that is a good resource for anyone working in, staying in, or working for a hospital. The address of the site is www.hospitalsafety.com.

Construction safety is an important topic for all involved in the design and construction industry, whether you are an architect, designer, engineer, contractor, sub-contractor, manufacturer, equipment supplier, facility manager or owner. Construction accidents can be reduced through knowledge, preparation, and execution of safe construction practices on every job site.

This website about construction safety offers every member of the design and construction team the opportunity to learn more about construction safety. Help to make your construction site safer starting today. Safe construction sites and safe construction practices help to prevent accidents. As a further benefit, a focus on construction safety contributes to a more professional work environment, leading to better quality work with fewer delays.

What you will find on www.constructionsafety.org: Construction Safety News, Products and Services Focused on Construction Safety, Services Focused on Construction Safety, Construction Safety Training and Books and Articles Written About Construction Safety.

Healthcare Design and Construction Resources

2008-12-24T17:22:00.001-08:00

Healthcare Design and Construction Resources:
Hospital Safety - This is the world's most comprehensive Hospital Safety resource. What you will find on HospitalSafety.com: Hospital Safety regulations, Hospital Safety Vendors, Hospital Safety Products, Hospital Safety Articles, Hospital Safety Software, and How Safe is Your Hospital.
hospitalsafety.com 59 West 19th Street - 6A, New York, NY 10011Ph : 212-463-0800 / Fx : 212-463-9898 / info@hospitalsafety.org HospitalSafety.org

Safest Hospital - SafestHospital.org is a privately-owned resource developed to help increase safety in the design, construction and operation of hospitals. It was founded to provide information and resources related to the The Safest Hospital Alliance, which was formed to combat the growing epidemic of medical errors in hospitals by developing the first comprehensive approach to patient safety. What you will find on SafestHospital.org : Safest Hospital regulations - Safest Hospital Vendors - Safest Hospital Products - Safest Hospital Articles - Safest Hospital software.Safest Hospital 59 West 19th Street - 6A, New York, NY 10011Ph : 212-463-0800 / Fx : 212-463-9898 / info@safesthospital.org http://www.safesthospital.org/

rx3d.com - Rx3D is a comprehensive directory for all products and services needed to design build and equip healthcare and laboratory facilities. What you will find on Rx3D: Healthcare and lab regulations – Healthcare and lab vendors – Healthcare and lab products – Healthcare and lab articles. rx3d.com 59 West 19th Street - 6A, New York, NY 10011Ph : 212-463-0800 / Fx : 212-463-9898 / info@rx3d.com http://www.rx3d.com/

Gap Analysis Companies

2008-12-24T17:21:00.000-08:00

Gap Analysis

Environmental Microbiology Laboratory, Inc. - We specialize in the analysis of air and surface samples for fungi, mold, bacteria, and allergens.
Environmental Microbiology Laboratory, Inc.1150 Bayhill Dr, #100, San Bruno, CA 94066 Ph : (866) 888-6653.http://www.emlab.com/

MicroTest Laboratories - MicroTest Laboratories provides complimentary Gap-Analysis compliance audits, certification and routine Environmental Microbiology monitoring [including viable/nonviable air and surface testing] of hoods and clean-rooms, on-site personnel training to USP<797>compliance [contamination control/aseptic technique], development of client-specific USP related SOP documentation and Low/Medium/High risk media-fill test programs. In addition, we offer end-product testing for sterility, endotoxin, purity and other analytical testing. MicroTest Laboratories is an FDA and DEA registered contract testing and manufacturing facility. MicroTest Laboratories, Inc.104 Gold Street, Agawam, MA 01001Ph : 413-786-1680 / Fx : 413-789-4334 / e-mail Info@microtestlabs.com http://www.microtestlabs.com/

Compliance Action Plans

2008-12-24T17:17:00.000-08:00

Compliance Action Plans

Bernstein & Associates, Architects - Architecture firm Specializing in Healthcare and lab design with a subspecialty in USP 797 consulting, USP 797 compliance action plans, and USP 797 architectural and engineering plans.
Bernstein & Assoc., Architects, PLLC59 West 19th Street - 6A, New York, NY 10011Ph : 212-463-8200 / Fx : 212-463-9898 / info@bernarch.com www.bernarch.com

Clinical IQ, LLC - Clinical IQ, LLC aims to serve as the trusted source for pharmacy information services and product solutions for all our customers who range from local start-up operations to established national companies in the hospital, home care, and specialty compounding industries. With this aim, Clinical IQ creates software, classroom training, web based training, audit tools, and many other informational products to make sterile compounding and related areas of pharmacy safer. Our mission is about improving patient safety through better standards-setting in sterile compounding and other practice areas is not our only goal, though it is the highest goal. Another goal is to improve the professional life ofpharmacists and technicians as we carry out our craft with the comforting knowledge of reduced probability of causing harm. You see, Clinical IQ and our partners are practitioners. We have real on-the-floor experience. We are aware of how the rigors and pressures of daily work and work habits impact quality beyond textbook formulas. Clinical IQ and our partners are on a mission to change pharmacy for the better and our work is never done. We hope you will join us.Clinical IQ, LLC184 Columbia Turnpike, #282, Florham Park, NJ 07932Ph : 973-765-9393 / Fx : 866-538-4783 / moreinfo@clinicaliq.com /www.clinicaliq.com

Global Quality Alliance, LLC - GQA is able to provide Compounding Pharmacies with services such as Gap Assessment of current facilities, procedures and systems with respect to <797> and all other USP requirements, create or update procedures required for compliance to <797>, assess the USP Risk Levels for current products, and provide on-site training for staff members on aseptic technique, environmental monitoring and other USP <797> requirements. Whether you are looking to become PCAB accredited, or simply desire to improve quality and compliance to offer greater assurance of patient safety, GQAs extensive experience in the pharmaceutical industry has provided an excellent evolution into the sterile compounding industry where we continue to provide expert service and advice.
Global Quality Alliance, LLC 300 Center Drive, Suite G, #310, Superior, Colorado 80027 In Colorado Ph: 303-459-2382 / Outside Colorado Ph : 866-216-2815 / Fx : Fax: 303-459-2382 / info@gqaconsulting.com www.gqaconsulting.com

Lasco Services - We’ll evaluate your space to design a new clean environment or renovate your existing compounding area. All work is done quickly, with minimal disturbance, with less expense than you might think and USP <797> compliant...guaranteed. Learn how Lasco Services can make it easy for you to be USP <797> compliant.
Lasco Services 601 Compton Irving, TX. 75061 Ph : 800-815-2726 / Fx : 972-513-1877 / info@lascoservices.com www.lascoservices.com

Quality Solutions, LLC - is a turn-key solutions provider offering USP 797 compliance in a cost-effective manner. Drawing from its compliance, validation and technical services background in the highly regulated Biotech/Pharma industry, Quality Solutions, LLC can assist your pharmacy in performing a GAP analysis, assess risk levels, create the supporting Quality Assurance plans, and execute all required testing. Furthermore, all HEPA and Laminar Flow Certifications are conducted using NSF certified engineers. Quality Solutions, LLCBaltimore, MD 21286Phone : 443-416-6102 / Fx: 410-823-5226 / Usp797@qualsolve.net www.qualsolve.net

RJ Lee Group, Inc. offers a wide variety of USP 797 compliance and consulting services with the understanding that each institution may face unique challenges when working toward compliance. Our scientific and technical staff coupled with consulting pharmacists offers years of experience with USP 797 related projects to help you formulate a compliance action plan that will fit your individual needs and budget.
RJ Lee Group, Inc.350 Fifth Avenue, Suite 5820 New York, New York 10118Ph : 212-613-2700 / Fx: 212-613-2701 / email: info@rjlg.com www.rjlg.com

Healthcare Project Management Including Pharmacy Design and USP 797 Compliant Pharmacies

2008-12-24T17:03:00.000-08:00

Healthcare Project Management Including Hospital Pharmacy and Retail Pharmacy Construction ... USP 797 Compliant Pharmacies a Specialty

Project Management

Empire Projects, Inc. - Project management company specializing in healthcare construction and laboratory project management, with a subspecialty in pharmacy construction, including USP 797 compliance, USP 797 regulations, USP 797 construction, and USP 797 project management.

Empire Projects, Inc.
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-0800 / Fx : 212-463-9898 /
info@EmpireProjects.com
http://www.empireprojects.com/

Architects Specializing in Pharmacy Design and USP 797 Compliant Pharmacies

2008-12-24T16:28:00.000-08:00

Architects

Bernstein & Associates, Architects - Architecture firm specializing in healthcare and lab design. This architecture firm also has a sub-specialty in pharmacy design, including the design and construction of usp 797 compliant pharmacies, utilizing the usp 797 2008 version guidelines. USP 797 consulting, USP 797 compliance action plans, and USP 797 architectural and engineering plans.

Bernstein & Assoc., Architects, PLLC
59 West 19th Street - 6A, New York, NY 10011
Ph : 212-463-8200 / Fx : 212-463-9898 / info@bernarch.com
www.bernarch.com

10/14/08: EMLab P&K Provides Lab Services & Supplies for USP 797 Compliance

2008-12-11T16:24:00.000-08:00

10/14/08: EMLab P&K Provides Lab Services & Supplies for USP 797 Compliance

PHOENIX, AZ, Oct 14, 2008 - The United States Pharmacopoeia (USP) recently released a new General Chapter <> providing procedures and requirements forcompounding sterile preparations. The standards in USP 797 apply to allpeople and facilities that prepare "compounding sterile preparations"including pharmacies, health care clinics and hospitals. Theserequirements include routine biological monitoring of the compoundingarea, including identification by an appropriately credentialed laboratoryof any microorganisms recovered. EMLab P&K is proud to provide analyticallab services, customer support, and the BioCassette, a sampler with designfeatures advantageous for USP 797 compliance.

EMLab P&K carries AIHA EMLAP accreditation for fungal as well as bacterialanalysis in labs across the United States. Further, it developed theBioCassette -- a patented sampling device that by design avoids highcapital expense and, importantly in the case of USP 797, is less prone tocontamination issues during the sampling process.

Belinda Vega, EMLab P&K's President, said, "EMLab P&K is not a newcomer toUSP 797. We have been providing these lab services for many years,developed the BioCassette with its intrinsic sampling advantages, and arestaying abreast of changes in the USP 797 compliance specifications. Withour highly qualified analysts and experience in providing analysis andsupport for USP 797, we are here to help CSP personnel and facilities whoare working on USP 797 compliance requirements."

EMLab P&K is recognized as one of the leading commercial indoor airquality laboratories in North America, specializing in analyzing air andsurface samples for mold, bacteria, asbestos and allergens. EMLab P&K hasreceived accreditations from AIHA, A2LA, NVLAP and CA-ELAP. For moreinformation, visit the official website at http://www.emlabpk.com or call(866) 888-6653.

CONTACT:
Cole S. Mackelprang
Director of Marketing
(858) 268-2762
WEB SITE: http://www.emlabpk.com

Architect's New Cancer Center Pharmacy Goes into Construction

2008-12-11T16:15:00.000-08:00

Bernstein & Associates, Architects, is pleased to announce that a new usp 797 compliant pharmacy, designed by the firm, is now in the construction phase. The phased pharmacy construction project is located at the Roswell Park Cancer Institute, one of the nation's premier cancer centers.

The pharmacy project is a complete reconstruction of the pharmacy. The renovation had to be phased, to allow continuous, uninterrupted operation of the pharmacy. The project includes all new iso 7 anteroom, iso 7 hazardous compounding room, and iso 7 non-hazardous compounding room. The facility is a state-of-the-art pharmacy, that includes the latest pharmacy automation equipment.

About Roswell Park Cancer Institute:

Roswell Park Cancer Institute (RPCI), is America's first cancer center founded in 1898 by Dr. Roswell Park. RPCI is the only upstate New York facility to hold the National Cancer Center designation of "comprehensive cancer center" and to serve as a member of the prestigious National Comprehensive Cancer Network. Over its long history, Roswell Park Cancer Institute has made fundamental contributions to reducing the cancer burden and has successfully maintained an exemplary leadership role in setting the national standards for cancer care, research and education.

About Bernstein & Associates, Architects:

Bernstein & Associates, Architects has specialized in healthcare and lab design and construction since the firm's founding in 1990. This well-known healthcare design firm has a sub-specialty in usp 797 compliant pharmacy design and construction. The firm's principal --- William N. Bernstein, AIA --- is a well known pharmacy architect who has written extensively on pharmacy design and construction including usp 797 compliant pharmacies. mr. Bernstein's usp 797 articles can be found on the usp 797 website http://www.usp797.org/.

For more information about healthcare and hospital design and construction, contact Bernstein & Associates, Architects at:
Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A, New York, NY 10011
Tel: 212.463.8200 Fax: 212.463.9898E
mail: info@bernarch.com
www.bernarch.com

RJLG announces updates on USP 797 services:

2008-12-11T16:12:00.000-08:00

RJLG is currently working for multiple clients in assessing the health, safety and environmental ‘fitness’ of construction sites. The work moved forward as a result of USP 797 related assessments of multiple hospital pharmacy sites.

Current examples of work performed for area health care systems include :
- Assessment of approximately 25 pharmacies for USP compliance
- Health and Safety Audit of a major construction project involving a neonatal intensive care unit, emergency department and parking garage
- Environmental, Health and Safety Training for facilities, safety and administrative staff - Environmental Assessment involving a hospital construction project
- We have also recently been contacted about performing Health and Safety audits for two major hospitals in Manhattan.

For more information, contact Dr. Farrell Melnick at fmelnick@rjlg.com.

About RJLG (www.rjlg.com):

RJLG is an organization of experts who provide the highest quality analytical and consulting services to our clients and partners. Our services are based on the highest level of expertise in microscopy, analytical instrumentation and software development.Leading organizations come to RJLG for more than data and information; they come for an innovative approach and technical solutions developed through our commitment to quality, reliability and customer satisfaction.

Contact:
Dr. Farrell Melnick
RJ Lee Group, Inc.
350 Fifth Avenue, Suite 5820
New York, NY 10118
(212)613-2709
fmelnick@rjlg.com

Workshops on USP 797

2008-12-04T18:58:00.000-08:00

Workshops: Practical Application of USP's General Chapter <797>
Course Description
USP <797> workshops will provide in-depth analysis of current compounding issues and insight into pharmacy-related content from the USP Pharmacists' Pharmacopeia and the USP–NF. The workshops will focus on the application of USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, and feature USP expert committee members and staff to provide guidance and address questions regarding the intent of the chapter. These workshops will also provide a forum for discussion of the current issues affecting facilities and practitioners. All workshops will be ACPE accredited.
Agenda (49KB)
Who Should Participate
Healthcare practitioners, particulary compounding professionals; regulatory/accrediting bodies; engineers, architects, environmental quality certifiers; and vendors of clean-room products and services
Format
2- Day Workshop
Content to be Covered
Hands on training and/or video training on facility designs, media fill test procedures, types of isolators, and clean rooms Developing a time line to meet the official date Facility's design and placement of primary engineering controls Clean room, buffer area, and ante room Compounding aseptic isolator (CAI) Compounding aseptic containment isolator (CACI) Developing gap analysis) CSP Microbial Contamination (low, medium, and high risk levels and 12 hour beyond use dating) Specialty CSPs Single-dose and multiple dose containers Immediate use Sterilization methods (sterilizing high-risk CSPs) Personnel cleaning and garbing Developing and implementing SOPs Disinfectants and cleaning Environmental quality and control Verification of compounding accuracy and sterility Training employees Please note that the workshops will have sessions providing hands on training relating to some of the key items listed above in addition to an extensive question and answer session with faculty members.
http://www.usp.org/education/pe/courses/genChapter797.html
***************************************************
For more information about usp 797, visit: www.usp797.org

2008 IV Update: USP <797> Final Revision

2008-12-01T10:21:00.000-08:00

2008 IV Update: USP <797> Final Revision:
2008 IV Update: USP <797> Final Revision:. Pharmacy Practice Seminar Pre- Conference Course. About the Course: The IV Update Course is designed for IV ...
www.utexas.edu/pharmacy/ce/iv.pdf - Similar pages

http://www.utexas.edu/pharmacy/ce/iv.pdf

New USP 797 Construction Compliance Project

2008-12-01T10:11:00.000-08:00

Y--USP 797 Pharmacy Compliance, Project Numer 540-05-401 (Construction)
Solicitation Number: VA-244-08-RP-0292
Agency: Department of Veterans AffairsOffice: Clarksburg VAMCLocation: Department of Veterans Affairs Medical Center
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Original Synopsis
Presolicitation
Nov 07, 2008
2:42 pm
Changed
Nov 21, 2008
12:24 pm

Solicitation Number:
VA-244-08-RP-0292
Notice Type:
Presolicitation
Synopsis:
Added: Nov 07, 2008 2:42 pm Solicitation will be released on or about Nov 21, 2008. All labor, materials, equipment and supervision to convert existing space to 797 Pharmacy Compliance Cleanroom Construction at the Louis A Johnson, VAMC 1 Medical Center Dr., Clarksburg, WV. 26301-4199. Work will include the demolition and removal of existing structures and associated electrical, mechanical, structural work as required by drawings and specifications.Project Name: USP 797 Pharmacy ComplianceProject Number: 540-05-401A 100% service disabled Veteran Owned Small Business set-a-side pursuant to 38 USC 8127 (c) and PL 109-461.IAW FAR paragraph 36.204, disclosure of the magnitude of this construction project is between $2,000,000.00 and $5,000.000.00Pending the availability of funds.
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Posted Date:
November 21, 2008
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Contracting Office Address:
Department of Veterans Affairs;Louis A Johnson, VAMC;Contracting Office (90C);1 Med Center DR;Clarksburg WV 26301-4199
Place of Performance:
Department of Veterans Affairs;Louis A Johnson, VA Medical Center;1 Medical Center Drive;Clarksburg, West Virginia26301-4199USA
Point of Contact(s):
Charles E LoarClarksburg(304) 623-3461Contracting

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General Information
Notice Type:
Presolicitation
Original Posted Date:
November 7, 2008
Posted Date:
November 21, 2008
Response Date:
December 22, 2008
Original Response Date:
December 22, 2008
Archiving Policy:
Automatic, on specified date
Original Archive Date:
January 6, 2009
Archive Date:
January 6, 2009
Original Set Aside:
Service-Disabled Veteran-Owned
Set Aside:
Service-Disabled Veteran-Owned
Classification Code:
Y -- Construction of structures and facilities
NAICS Code:
236 -- Construction of Buildings/236220 -- Commercial and Institutional Building Construction
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For more information about usp 797, go to: www.usp797.org

usp797org.blogspot.com: Terms and Conditions of Use

2008-11-29T17:12:00.000-08:00

Terms and Conditions of Use:
PLEASE READ THESE TERMS AND CONDITIONS OF USE CAREFULLY BEFORE USING THIS SITE.

By using this site, you signify your assent to these Terms and Conditions. If you do not agree to all of these Terms and Conditions of use, do not use this site!

Usp797org.blogspot.com. ("Usp797org.blogspot.com") may revise and update these Terms and Conditions at any time. Your continued usage of the Usp797org.blogspot.com website ("Usp797org.blogspot.com site," or the "site,") will mean you accept those changes.

This site is a resource for the pharmaceutical community. Opinions expressed and companies listed are for information only. All final decisions related to facility upgrades, purchase of products, and/or use of products, should be made only after consultation with and direction from a pharmaceutical consultant in conjunction with the pharmaceutical staff and director.

The contents of the Usp797org.blogspot.com site, such as text, graphics, images, information obtained from Usp797org.blogspot.com's licensors, and other material contained on the Usp797org.blogspot.com site ("Content") are for informational purposes only. The Content is not intended to be a substitute for professional pharmaceutical consulting specific to a specific pharmacy. Always seek the advice of your pharmacy consultant and pharmaceutical staff/director, with any questions you may have regarding usp797. Never disregard professional medical advice or delay in seeking it because of something you have read on the Usp797org.blogspot.com site!

In no event shall Usp797org.blogspot.com, its licensors, its suppliers, or any third parties mentioned on the Usp797org.blogspot.com site be liable for any damages (including, without limitation, incidental and consequential damages, personal injury/wrongful death, lost profits, or damages resulting from lost data or business interruption) resulting from the use of content on the Usp797org.blogspot.com site.

Usp797org.blogspot.com may provide links to third-party web sites. Usp797org.blogspot.com does not recommend and does not endorse the content on any third-party websites.

Usp797org.blogspot.com is not responsible for the content of linked third-party sites, sites framed within the Usp797org.blogspot.com site, third-party sites provided as search results, or third-party advertisements, and does not make any representations regarding their content or accuracy. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites. Usp797org.blogspot.com does not endorse any product, service, or treatment advertised on the Usp797org.blogspot.com site.

Indemnity: You agree to defend, indemnify, and hold Usp797org.blogspot.com, its officers, directors, employees, agents, licensors, and suppliers, harmless from and against any claims, actions or demands, liabilities and settlements including without limitation, reasonable legal and accounting fees, resulting from, or alleged to result from, your violation of these Terms and Conditions.

State-by-State Map of USP 797

2008-11-29T17:02:00.000-08:00

US Boards of Pharmacy, Sterile Compounding Laws, Regulations and CE Requirements Map

For map view, go to: http://www.clinicaliq.com/component/option,com_google_maps/Itemid,111/

For text link view, go to: http://www.clinicaliq.com/content/category/1/48/125/

This informational reference map is being presented to assist you in understanding your state's laws and regulations relative to USP Chapter 797. You will also find specific information on your state's continuing education (CE) requirements. This research project was conducted by CriticalPoint, LLC and NABP. Please click on your state balloon to read the details of this research. By clicking on any state balloon you are indicating you have read and agreed to the clinicaliq.com Terms of Use. For additional information about this survey please read the information below the map. Note: this information is a starting point for analysis, check directly with your state board before proceeding with any project, to make sure you have the latest or pending data from that state.

To use the map move your mouse over the state you want to view and click on the colored balloon which will display a summary screen showing your boards contact information, link to the state’s website, state’s 797 Compliance status and a link to the detailed research information which includes information on license renewal requirements.

The three status levels are Direct (green), Indirect (yellow), or No Reference (red). If the state level is Direct (green) then the laws and regulation are harmonized with USP Chapter 797. If the state level is Indirect (yellow) then the laws and regulations do not specifically site USP Chapter 797 but there are laws and regulations for Sterile Compounding and/or Parenteral Nutrition. If the state level is No Reference (red) then there are currently no laws or regulations referencing USP Chapter 797 or Sterile Compounding/Parenteral Nutrition.

For Pharmacy Technician CE requirements please visit the PTCB web site.

Where to Purchase the USP 797 Guidelines (edition 2008)

2008-11-29T17:01:00.000-08:00

http://www.usp.org/products/797Guidebook/

AIHA Creates New Workgroup to Study USP 797

2008-11-29T16:07:00.000-08:00

11/24/08: American Industrial Hygiene Association Creates New Workgroup to Study USP 797. Mission: Mission: Share information on the safe and healthful preparation and/or administration of healthcare involving hazardous or sterile pharmaceuticals; Develop model risk-based programs for the handling of hazardous drugs and/or sterile preparations; Develop models for the incorporation of risk-based programs that mesh patient safety and health, quality assurance, occupational health and safety, and environmental control into a facility continuous improvement program; Develop audit tools for simultaneously assuring patient safety and health, quality assurance, occupational health and safety, and environmental control; Expand the understanding of industrial hygiene issues in healthcare facilities.Project Team Lead:
Lawrence H. Hecker, CIH, PhD
Matthew L. Berkheiser, CSP
Richard D. Bennett, MSPH, CIH
Suzanne S. Blevins
Curtis E. Cannell, CIH
Sumati Dhawan
Brian E Hroch, CIH
J. Daniel James, CIH
Martin L. Jones, PhD, CIH, CSP
John F. Koerner, CIH
Thomas D. Murphy, CIH,CSP,CHMM
Leo T. Old, CIH,PE
John N. Rice
Shirley A. Smith, ASCP
Marissa L. Vieno
Shelley R. Wheeling-Park, MPH, CHMM, CSP, CIH
Matthew M. Winn
Sandra L. Witek-Eames For more information: http://www.aiha.org/Content/InsideAIHA/Volunteer+Groups/USP797.htm

New USP 797 Article by Bernstein & Associates, Architects

2008-11-29T16:06:00.000-08:00

10/17/08: Bernstein & Associates, Architects (www.bernarch.com) announces that a new article on usp 797 facility design has been published in Health Facilities Management.

Entitled "Clean Spaces: A look at the revised and reissued USP 797 pharmacy design regulation", it was written by company principal William N. Bernstein, AIA. The article is a review of the new, 2008, usp 797 guideline, in terms of its impact on the design and construction of usp 797 compliant facilities. For further information on design and construction of usp 797 compliant facilities, contact:William N. Bernstein, AIAPrincipal Bernstein & Associates, Architects - PLLC 59 West 19th Street - 6A New York, NY 10011Office: 212.463.8200 Fax: 212.463.9898Email: wb@bernarch.com www.bernarch.com

Hospital Selects Software to Help with USP 797 Chapter Compliance

2008-11-29T16:05:00.000-08:00

"Henry Ford Macomb Hospital Selects Simplifi 797 to Help with USP Chapter 797 Compliance", "Pharmacy OneSource, 13 September, 2008

Software helps hospital pharmacy be in compliance with new compounding guidelines
Bellevue, WA -- Pharmacy OneSource, Inc., software as a service provider to more than 1,200 hospitals in the United States, announced today that Henry Ford Macomb Hospital has adopted Simplifi 797 to simplify meeting all of the requirements of USP Chapter 797 for compounding sites throughout the facility.
As a 435-bed facility providing comprehensive, acute care, Henry Ford Macomb Hospital in Clinton Township, Michigan provides an environment where pharmacy personnel must consistently maintain a safe and efficient pharmaceutical distribution system, while at the same time provide high-quality clinical services for their patients. With no room for less than optimal performance in either area, the pharmacy department continuously searches for new tools to aid in the provision of these services, and Simplifi 797 is the latest example.
"With Simplifi 797, our department has a simple and efficient way to track real-time compliance with USP Chapter 797 without the need for a labor-intensive paper trail," said Steve Fecteau, Manager Pharmacy Services for Henry Ford Macomb Hospital. "The system has also provided a well-organized approach to the many different requirements of USP Chapter 797, which has helped to make implementation of all of the changes less overwhelming."
Simplifi 797 is a web-based application that automates, integrates and streamlines the quality activities and documentation required to meet USP Chapter 797. Simplifi 797 manages task scheduling and monitoring and automates the reporting of exceptions and compliance.
"Simplifi 797 helps hospitals easily implement a robust quality control program. Henry Ford Macomb Hospital has taken a great step forward in protecting their patients with the adoption of Simplifi 797," said Keith Streckenbach, Chief Strategy Officer for Pharmacy OneSource.
More information about Simplifi 797 can be found at: www.simplifi797.com
About Pharmacy OneSource (www.pharmacyonesource.com)Pharmacy OneSource is healthcare's #1 Software-as-a-Service (SaaS) provider. Our more than 50 innovative team members provide best-in-class, SaaS solutions to current and future challenges within health-systems worldwide. Our SaaS solutions contribute to swift and safe healthcare through earlier, easier and better access to data. More than 1,200 healthcare organizations worldwide utilize our HIPAA compliant web-based services: Accupedia, Amplifi, Quantifi, ScheduleRx, Sentri7, Simplifi 797, and UnitStock.
About Henry Ford Macomb Hospital (www.henryfordmacomb.com)Henry Ford Macomb Hospital is a 435-bed hospital that provides comprehensive, acute care. Specialty services include a Heart & Vascular Institute, a cancer care center, a birthing center with 18 labor, deliver, recovery and post-partum suites. The hospital also has a 42-bed inpatient rehabilitation program, an ambulatory and minimally invasive surgery center and leading diagnostic imaging.
addthis_pub = 'p1source';

Web-Based Service to Simplify USP Chapter 797 Compliance

2008-11-29T16:04:00.000-08:00

"Eric S. Kastango, MBA, RPh, FASHP, Teams with Healthprolink to Put Best Practices Into Web-Based Service to Simplify USP Chapter 797 Compliance", (c) Pharmacy OneSource, November 08, 2005

November 08, 2005 - Bellevue, WA -- Healthprolink Corporation and Clinical IQ, LLC signed a multi-year agreement to develop, market and service Simplifi 797, a web-based application that simplifies meeting all of the requirements of USP Chapter 797. On January 1, 2004, the first national pharmacy standard for compounding sterile preparations, USP Chapter 797, was published. The chapter establishes practice standards that are applicable to all settings (hospitals, retail, home infusion, ambulatory care, physician offices, nursing homes, etc.) where sterile preparations are compounded.Pharmacists and technicians are required to implement this standard as a means to improve the quality of compounded sterile preparations. Simplifi 797 automates all of the processes required to meet or exceed USP Chapter 797 and integrates practical tools to address all of the identified quality domains. As part of the agreement, Eric S. Kastango, President and Founder of Clinical IQ, LLC, will provide content and expert rules based upon 25 years of aseptic compounding experience in hospital, homecare and GMP environments. Healthprolink, provider of application services to over 900 hospitals, will design and develop the application in addition to providing marketing and ongoing customer support."We're absolutely thrilled to combine the experience of Eric Kastango with our expertise in application services," said Keith Streckenbach, Executive Vice President of Healthprolink. "This combination delivers comprehensive, yet easy-to-use, methods to assist pharmacists and technicians to meet or exceed USP Chapter 797."This web-based application automates, integrates and streamlines the quality activities and documentation required to meet USP Chapter 797. Simplifi 797 utilizes expert rules, manages task scheduling and monitoring and automates the reporting of exceptions and compliance. In addition, practice-based policies and procedures are integrated into the application to simplify compliance and include important aspects such as staff competencies, environmental monitoring, as well as media qualification."I am excited about partnering with Healthprolink, a leader in their industry, to create a tool for pharmacists and technicians that assists them in meeting 797 efficiently while also building a knowledgeable workforce," said Eric S. Kastango. Simplifi 797 will be officially launched on Sunday, December 4th at the meeting of the American Society of Health-System Pharmacists (ASHP) to be held at the Las Vegas Convention Center in Las Vegas, Nevada.

New Article by Bernstein & Associates, Architects on Architectural and Environmental Changes Required for USP 797 (usp 2004 version)

2008-11-29T16:01:00.000-08:00

07/15/05: Bernstein &Associates, Architects (www.bernarch.com) announces that a new article on usp 797 facility design has been published in Health Facilities Management.

Entitled "Pharmacy Facts: Architectural and Environmental Changes Required for USP 797", it was written by company principal William N. Bernstein, AIA. The article is a review of the 2005 usp 797 guideline, in terms of its impact on the design and construction of usp 797 compliant facilities.
For further information on design and construction of usp 797 compliant facilities, contact:
William N. Bernstein, AIA
Principal Bernstein &Associates, Architects - PLLC
59 West 19th Street - 6A New York, NY 10011
Office: 212.463.8200 Fax: 212.463.9898
Email: wb@bernarch.com http://www.bernarch.com/

USP Chapter 797 on Enforceability

2008-11-29T15:58:00.000-08:00

USP Chapter 797 on Enforceability, (c) USP 797 Guidebook to Pharmaceutical Compounding-Sterile Preparations, 25 August 2008

In the USP 797 Guidebook to Pharmaceutical Compounding-Sterile Preparations, USP “attempts to clarify the enforceability” of Chapter 797. The guidebook is a compilation of the full text of Chapter 797, public comments with responses from the committee which formulated the document, and five pages addressing enforceability.
Chapter 797 applies to practitioners. Practitioners are regulated by state agencies and in general, the FDA will defer to states with regard to Chapter 797. The FDA will act with the states in investigating allegations of poor quality compounded drugs, but is willing and able under the Federal Food Drug Cosmetic Act (FFDCA) to act on its own initiative.
Approaches by state to Chapter 797 generally fall into three categories, discussed in detail below in language drawn from the USP publication.
States that require compliance with USP standards
The following states likely fall into this category by having broad legal or regulatory language that requires compliance with the USP-NF generally. Since Chapter 797 is part of USP-NF, “these Boards appear to require compliance with the latest revision of the chapter”:
Massachusetts
South Dakota
South Carolina
Virginia
West Virginia
States that explicitly reference Chapter 797
The following states have laws or regulations that explicitly require compliance to varying degrees, with some broader assertions:
Minnesota
Utah: broad assertions that Chapter 797 shall apply
Georgia: immediate-use products exempted
Indiana
Maryland
New Mexico
States that include some provisions from Chapter 797 in their regulations
Some text incorporating portions of 797 has been adopted by the following states:
Arizona
Arkansas
Texas
Ohio
Reference:
USP 797 Guidebook to Pharmaceutical Compounding-Sterile Preparations, 2008
International Oncology Network (ION)An AmerisourceBergen Specialty Group Company 3101 Gaylord Parkway Frisco, TX 75034

USP Releases Chapter 797 Revision

2008-11-29T15:44:00.000-08:00

"USP Releases Chapter 797 Revision", (c) Cheryl Thompson, Health-System Pharmacy News, 3/12/07

LAS VEGAS, NV, 03 December 2007 — The new version of United States Pharmacopeia (USP) chapter 797, "Pharmaceutical Compounding—Sterile Preparations," became publicly available today and goes into effect June 1, 2008.
For a limited time, U.S. Pharmacopeia stated, the new version of the chapter on compounded sterile preparations (CSPs) is accessible for no fee at www.usp.org/USPNF/pf/generalChapter797.html. This free offering ends January 1 when USP <797> Guidebook to Pharmaceutical Compounding—Sterile Preparations goes on sale.
The standards-setting organization said the current version of chapter 797, as it appears in The United States Pharmacopeia, 31st Revision, and The National Formulary, 26th Edition, remains the official text until publication of the edition's second supplement, scheduled for June 1, 2008.
The text of the new version is not entirely identical to the proposed revision published in May 2006. For example, the proposed section "Environmental Monitoring" was deleted and the content incorporated elsewhere. The new version has the subsection "Depyrogenation by Dry Heat," whereas the proposed revision did not.
In revising USP chapter 797 from the original text, the organization's Sterile Compounding Expert Committee added the following sections:
Definitions,
Intermediate-Use CSPs,
Single-Dose and Multiple-Dose Containers,
Hazardous Drugs as CSPs,
Radiopharmaceuticals as CSPs,
Allergen Extracts as CSPs,
Personnel Training and Competency Evaluation of Garbing, Aseptic Work Practices, and Cleaning/Disinfection Procedures,
Elements of Quality Control, and
Abbreviations and Acronyms.
The committee also created the section "Maintaining Sterility, Purity and Stability of Dispensed and Distributed CSPs" from the former "Maintaining Product Quality and Control after the CSP Leaves the Pharmacy" and added four appendixes.
"ASHP is pleased," said Cynthia Reilly, ASHP's director of clinical standards and quality, "that USP has released the much-anticipated revisions to chapter 797 to give practitioners time to prepare for when that document becomes official in June.
"The timing also provides ASHP an excellent opportunity to provide valuable information to our members—both here at MCM, at the Midyear Clinical Meeting, via educational sessions taught by experts who were involved in the revision and also on an ongoing basis through our practice standard, Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products.
"We'll be reviewing the new USP document carefully with an eye towards creating tools and resources that will help our members comply with state board of pharmacy regulations and accreditation standards that might be impacted by the USP changes," Reilly said.

Particle Monitoring to Meet USP 797

2008-11-29T15:38:00.000-08:00

Particle Monitoring to Meet USP <797>
1. Introduction
The United States Pharmacopoeia (USP) recently released procedures and requirements for compounding sterile preparations. General chapter <797>, titled “Pharmaceutical Compounding – Sterile Preparations,” states that sterile compounding procedures require clean facilities, specific training for operators, air quality evaluations, and a sound knowledge of sterilization and stability principles. The nature of defining how these preparations shall be manufactured is related to the potential risk to patients should errors occur.
This paper reviews the requirements for non-viable particle limits and the monitoring of those areas where product is exposed.
2. Environmental Requirements
Products are manufactured according to one of three risk factors: low, medium, and high. Those products which are manufactured as an aseptic parenteral have the greatest risk of contamination, and therefore they must be manufactured in an area tolerating only the lowest level of risk. “Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are errors of non-sterility and large errors in ingredients,” 1 and therefore the greatest level of control over manufacturing must be proven. They must be manufactured under a “laminar flow clean-air hood, barrier isolator, or other contamination control device appropriate for the risk level, that provide an adequate critical site environment”. 1
Critical site environments, defined below, must prove that they meet the international standard for cleanliness to ISO14644-1 Class 5, where no more than 3520 particles at 0.5 mm are present per cubic meter of sampled air. The ISO classes will be briefly discussed in this paper.
The supporting area, or clean room areas where the laminar flow stations are located, should meet at least ISO 8 air quality. The supporting area will be discussed in greater detail below.
For a better understanding of the requirements, a document to read in conjunction with the USP <797> is the Food and Drug Administration’s (FDA) Guidance for Industry Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice, September 2004. This document identifies how the manufacturing of sterile products should be undertaken and defines certain elements of critical environments.
Defining Critical and Supporting Areas
Critical areas
The USP defines a critical area as the central location for performing sterile manipulations which should be a laminar flow, ISO 5 environment. The FDA Guidance defines it as the following:
A critical area is one in which the sterilized drug product, containers, and closures are exposed to environmental conditions that must be designed to maintain product sterility (§ 211.42(c)(10)). Activities conducted in such areas include manipulations (e.g., aseptic connections, sterile ingredient additions) of sterile materials prior to and during filling and closing operations. 2
The USP and the FDA share a harmonized view of both the definition of critical areas and the activities which are critical in nature. In addition, the FDA defines the limit of particles in air:
Air in the immediate proximity of exposed sterilized containers/closures and filling/closing operations would be of appropriate particle quality when it has a per-cubic-meter particle count of no more than 3520 in a size range of 0.5 μm and larger when counted at representative locations normally not more than 1 foot away from the work site, within the airflow, and during filling/closing operations. This level of air cleanliness is also known as Class 100 (ISO 5). 2
Therefore, those activities that pose the greatest risk to final product quality must be done in an environment that meets ISO 5, again showing harmonization of the two references.
Supporting Areas
The USP defines this area as a controlled environment that minimizes the contamination of the area immediately surrounding the critical area. The FDA defines this area as the following:
Supporting clean areas can have various classifications and functions. Many support areas function as zones in which non-sterile components, formulated products, in-process materials, equipment, and container/closures are prepared, held, or transferred. These environments are soundly designed when they minimize the level of particle contaminants in the final product and control the microbiological content (bio-burden) of articles and components that are subsequently sterilized. 2
The USP states that supporting areas must meet an air quality of at least ISO 8; the FDA recommends the following:
The nature of the activities conducted in a supporting clean area determines its classification. FDA recommends that the area immediately adjacent to the aseptic processing line meet, at a minimum, Class 10,000 (ISO 7) standards (see Table 1) under dynamic conditions. Manufacturers can also classify this area as Class 1,000 (ISO 6) or maintain the entire aseptic filling room at Class 100 (ISO 5). An area classified at a Class 100,000 (ISO 8) air cleanliness level is appropriate for less critical activities (e.g., equipment cleaning). 2
Again, there is harmonization between the FDA and the USP on the expectations of supporting clean areas, though the FDA is more precise in defining that the risk of each area should be assessed and a classification assigned according to that risk. The table below is an extract from the FDA guidance and can be directly compared with that shown in USP <797>. The table also identifies the maximum permissible microbiological limits for the associated manufacturing areas.
Clean Area Classification
(0.5 µm particles/ft3)
ISO Designation
> 0.5 µm particles/m3
Microbiological Active Air Action Levels (cfu/m3 )
Microbiological Settling Plates Action Levels (diam. 90mm; cfu/4 hours)
100
5
3,520
1
1
1000
6
35,200
7
3
10,000
7
352,000
10
5
100,000
8
3,520,000
100
50

3. Monitoring Frequency
In accordance with the USP <797>, a critical area must prove to meet ISO 5 classification at least once per six-month period. The same interval is also found in the ISO14644-2 guide. The frequency of determining the cleanliness class of the supporting areas is also at least once per six months as recommended by the USP. This interval is defined in the ISO14644-2 as being at least every twelve months, so the expectations of the USP are higher than that of a typical ISO 8 clean room.
Because the FDA has a more risk-based approach to monitoring, a sample every “n” months is insufficient to determine if a specific batch of product was manufactured to specification and quality-defined attributes.
We recommend that measurements to confirm air cleanliness in critical areas be taken at sites where there is most potential risk to the exposed sterilized product, containers, and closures. The particle counting probe should be placed in an orientation demonstrated to obtain a meaningful sample. Regular monitoring should be performed during each production shift. We recommend conducting nonviable particle monitoring with a remote counting system. These systems are capable of collecting more comprehensive data and are generally less invasive than portable particle counters.2
Therefore, environmental monitoring should be performed during those periods when product is being exposed to the ambient environment, and records should show that a level of control was present during these periods. The FDA sets no recommendations for the supporting areas; however, the Parenteral Drug Association (PDA) recommends that they be sampled at least once per week for ISO 7 and at least once per month for ISO 8 (PDA Journal of Pharmaceutical Science and Technology, Volume 57 No.2 March/April 2003).
For more information on particle monitoring in pharmaceutical environments, read Particle Measuring Systems Application Note, “Particle Monitoring Requirements in Pharmaceutical Cleanrooms.”
Mark Hallworth
Pharmaceutical Business Manager
Particle Measuring Systems
Ackowledgements
1 USP. United States Pharmacopoeia General Chapter <797> Pharmaceutical Compounding – Sterile Preparations.
2 FDA. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice. September 2004.
Particle Measuring Systems © 2005

Steps to Build a USP 797 Compliant Facility

2008-11-29T15:32:00.000-08:00

Steps to Build a USP 797 Compliant Facility

A suggested step-by-step methodology for USP 797 compliance is as follows:
JCAHO began surveying for compliance with USP 797 on July 1, 2004, so efforts to comply with USP 797 should have begun and/or must begin immediately

To begin with, assemble a team within your healthcare institution consisting of : Chief Pharmacist, Director of Facilities, Director of Engineering, and Appropriate Administrator
Identify, with the guidance of the Chief Pharmacist, those pharmacies within the health care institution where sterile compounding is done

Create a Gap Analysis document, either in-house, or by hiring a consultant that specializes in Gap Analysis documents, such as Clinical IQ (http://www.clinicaliq.com/)

Create a Compliance Action Plan, either in-house, or by hiring an architect that specializes in Compliance Action Plans, such as Bernstein & Assoc. (http://www.bernarch.com/)

Have the architect create construction documents and specifications, indicating the detailed scope required for the project

Send out the drawings and specifications to 3-5 qualified general contractors who specialize in health care and laboratory space

Award the project to the selected contractor Work with architect and contractor to complete work in a thorough manner, meeting all project specifications.

For more information about usp 797, go to: http://www.usp797.org/

For more information about usp 797-compliant architecture, engineering and construction, go to: http://www.bernarch.com/.

Q & A on usp 797: Sink in Anteroom

2008-11-24T20:56:00.000-08:00

Questions and Answers on USP 797

RJLG Question 6: I have received some conflicting information regarding USP 797 standards related to the presence of a sink in an anteroom meeting ISO Class 7. In reviewing the Revision Bulletin (copyright 2008), an ISO Class 7 buffer area shall not contain sinks or floor drains, but would the presence of a sink in a physically separate, positive pressure ISO Class 7 anteroom adjacent to a negative pressure ISO Class 7 buffer area somehow detract from the anteroom's ISO classification?
Specifically, I have a new hospital pharmacy which has provided certification documentation that the small anteroom leading into the hazardous drug preparation area (negative pressure ISO Class 7 buffer area containing ISO Class 5 PEC) meets the established guidelines for ISO Class 7 with the presence of a sink with a drain (located next to the doorway separating the anteroom from the buffer area). This was in a pre-operational, non-dynamic state. There are now some conflicting opinions about the sink and its impact on the ISO classification of the anteroom. Any guidance on this situation would be much appreciated.

RJLG Answer 6: USP<797> states “The buffer area shall not contain sources of water (sinks) or floor drains.” This is intended to reduce airborne microbial and other particulate contamination adjacent to critical sites such as ISO Class 5 primary engineering controls (PECs). The ante area sink is a critical component to personnel cleansing and garbing prior to entrance into the buffer area. Your environmental sampling programs (non-viable and viable particle testing), conducted before commissioning of the pharmacy and periodically thereafter during dynamic operating conditions, will determine the impact of a sink or other objects on the ISO classifications of your ante and buffer areas.

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mailto:613-2709mzock@rjlg.com

What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : mailto:info@usp797.org

Q & A on usp 797: Low Volume of Chemotherapy Drugs

2008-11-24T20:54:00.000-08:00

Questions and Answers on USP 797

RJLG Question 5: I read somewhere in the USP 797 that it was acceptable to mix a low volume of chemotherapy agents without a separate negative pressure room as long as CSTD's were used. Is this correct? Also--what is considered a low volume?

RJLG Answer 5: When a closed system transfer device (CSTD) is used within the ISO Class 5 biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI) for low volume hazardous drug preparation only, a non-negative pressure room is acceptable provided other precautions and recommendations are followed. For instance: all hazardous drugs shall be separate from non-hazardous drugs in storage (separate storage area) and handling (dedicated BSC or CACI); the BSC or CACI shall be placed in a restricted access ISO Class 7 non-negative pressure buffer area, or a CACI may be used outside of the ISO Class 7 buffer area provided it is in a restricted access room that meets the conditions in the section of USP<797> entitled Placement of Primary Engineering Controls; proper procedures, training, and personal protective equipment (PPE) are employed; and containment should be verified by routine monitoring. The Hazardous Drugs as CSPs section of USP<797> does not describe low volume. Our interpretation is, if the use of a CACI (100% vented glovebox) or two tiers of containment (CSTD within a CACI or BSC) will allow for the ability to handle the total peak volume of hazardous drugs at the given facility without compromising safety, sterility, quality, or workflow, then the non-negative pressure room is acceptable as described above.

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mzock@rjlg.com

What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org

Q & A on usp 797: Privately Owned Physician's Office

2008-11-24T20:52:00.000-08:00

Questions and Answers on USP 797

RJLG Question 4: We are a privately owned physicians office and do not have pharmacy or pharmacist. We have (2) RN's that are trained and certified to mix and give chemo drugs. We follow NIOSH guidelines. De we have to follow the USP797 guidelines?

RJLG Answer 4: If your institution prepares compounded sterile preparations (CSPs) which meet the definition of the specific categories described in USP797 (low-risk level, medium-risk level, high-risk level, or immediate use), including hazardous drugs as CSPs, you must comply with USP797. The standards are intended to apply to all persons who prepare CSPs and all places where CSPs are prepared including physicians offices.

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mzock@rjlg.com

What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org

Q & A on usp 797: Immediate Use Exemption

2008-11-24T20:48:00.000-08:00

Questions and Answers on USP 797

RJLG Question 3: I work in a Nuclear Medicine Department and we use unit dose for everything but emergency scans. We have changed our policy to receive multiple separate syringes with varying activities to produce several single dose kits. During preparation aseptic techniques will be followed. The kit will be used within an hour, for only one patient and no more than two entries into any one vial. My concern is preparing an Ultra tag kit for a G.I.Bleed. If we follow the manufacturer's preparation and use the correct personal protective equipment are we covered under the immediate use exemption?

RJLG Answer 3: The Immediate use provision is intended for those situations which call the immediate administration of a compounded sterile product. The important factor here is that these items can not be prepared and stored in advance for any anticipated needs. If the compounds you are referring to are considered hazardous all hazardous materials must be manipulated within a bio safety hood or glove box. If preparation is done outside of a BSC or similar device, to meet the requirements for immediate use, preparations must: 1. Follow Aseptic technique. 2. Be limited to simple manipulations admixing no more than 3 ingredients. 3. Not exceed more than 2 entries into any 1 vial 4. Begin to be administered within 1 hour of starting preparation. 5. If the administration of the compounded product will not be completed by the person who prepared it, the compounded product must be properly labeled with patient name, all ingredient names and strengths, the initials of the preparer and the exact beyond use date (BUD) and time. 6. Be properly and safely discarded if administration does not begin within 1 hour following the start of preparation. The procedure you have outlined appears to meet these requirements and can be considered immediate use.

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

Royston Browne, PharmD is currently the Manager of the oncology Pharmacy at Montefiore Medical Center in the Bronx New York. He has worked in this capacity for the past 11 years and has provided leadership in complying with USP 797 policies at this institution .
Royston Browne, BS PharmDManager, Oncology PharmacyMontefiore Medical CenterHoffheimer 100 - 111 East 210 StreetBronx, NY 10467Tel: (718) 920-5778Fax: (718) 515-9529Pager: (917) 898-1918E-Mail: RBrowne@Montefiore.org

What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org

Q&A on usp 797: Minimum Time for a Settle Plate Sample

2008-11-24T20:45:00.000-08:00

Questions and Answers on USP 797

RJLG Question 2: What is the minimum time for a settle plate sample. We are currently using 15 min is this enough.

RJLG Answer 2: Although some still use settling plates to qualitatively assess viable airborne microorganisms, this method is not adequate for quantifying airborne microbial burden in clean environments such as ISO classified hoods (clean benches, BSCs, CAIs), buffer or clean rooms, or ante areas. Your USP 797 sampling plan should include active air sampling using appropriate electronic air sampling equipment and trained personnel. For more information you may refer to Environmental Viable Airborne Particle Testing Program under USP<797> Pharmaceutical Compounding – Sterile Preparations, and Methodology and Instrumentation for Quantitation of Viable Airborne Microorganisms under USP<1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environment.

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew ZockRJ Lee Group, Inc.350 Fifth Avenue, Suite 5820New York, NY 10118(212)613-2709mzock@rjlg.com

What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org

Q & A on USP 797: Fingertip Sampling

2008-11-24T20:40:00.000-08:00

Questions and Answers on USP 797

RJLG Question 1: Question on fingertip sampling: I have a question regarding fingertip sampling. On page 34, the recommended action levels for microbial contamination states that the action levels for ISO Class 5 sampling is >3. Yet when I look at the appendix I for gloved fingertip sampling it states that "All employees shall successfully complete an initial competency evaluation and gloved fingertip/thumb sampling procedure (0 cfu) no less than three times before initially being allowed to compound CSPs for human use". I'm confused as to which one applies. Can you clarify for me? Thanks.

RJLG Answer 1: USP<797> clearly states that the initial competency evaluation and gloved fingertip/thumb sampling procedure does require 0 CFU for successful completion (performed at least three times) as quoted in your question.Table 4. Recommended Action Levels for Microbial Contamination, which shows >3 CFU as an action level for fingertip samples in an ISO Class 5 environment, applies to annual re-evaluation of compounding personnel who compound low and medium-risk level CSPs, and semi-annual re-evaluation for high-risk level CSPs. However, USP<797> states that the tables of recommended action levels are intended to be used as guidelines only, and “Action levels are determined on the basis of CFU data gathered at each sampling location and trended over time.”

Answer provided as a courtesy to USP797.org by RJ Lee Group, Inc. (RJLG) and/or associates of RJLG. We assume no liability for the use or interpretation of this information. Please note that USP797.org is not responsible for this answer.

Matthew Zock is an industrial hygienist with the technical consulting services group at RJ Lee Group, Inc. Mr. Zock provides a variety of industrial hygiene, health & safety, and environmental consulting services for heath care, general industry, and litigation support. He manages RJLG's USP 797 services including environmental sampling (microbial), hazardous drug monitoring, and facility design and operation audits. Mr. Zock received his Bachelors in Biology from Clarion University of Pennsylvania, and his Masters in Environmental and Occupational Health Sciences from Hunter College. He can be reached as follows:Matthew Zock RJ Lee Group, Inc. 350 Fifth Avenue, Suite 5820 New York, NY 10118 (212)613-2709 mzock@rjlg.com

What you will find on USP797.org : USP 797 regulations – USP 797 vendors – USP 797 products – USP 797 articles – USP 797 cleanrooms – USP 797 barrier isolators - USP 797 software
© 2005 USP 797.org / 59 West 19th St. : New York, NY 10011 : (212-463-0800) : info@usp797.org

New Article on USP 797 Pharmacy Design and Construction

2008-11-23T11:53:00.000-08:00

New Article on USP 797 Pharmacy Design and Construction

Bernstein & Associates, Architects is pleased to announce the publication of a new article about recent trends in pharmacy design, including the design of pharmaceutical compounding suites.

The article includes discussion of the design and construction implications of the 2008 version of USP 797.

It also features details of the new pharmacy and pharmaceutical compounding suite designed by the firm for the Roswell Park Cancer Institute in Buffalo, NY.

Entitled "Clean Spaces: A Look at the Revised and Reissued USP 797 Pharmacy Design Regulation", it was written by the firm's principal --- William N. Bernstein, AIA --- and was published in the October issue of Health Facilities Management.

To view this article: http://www.hhnmag.com/hhnmag_app/jsp/articledisplay.jsp?dcrpath=HFMMAGAZINE/Article/data/10OCT2008/0810HFM_DEPT_Codes&domain=HFMMAGAZINE

About Bernstein & Associates, Architects:

Founded in 1990, *Bernstein & Assoc., Architects - PLLC* is an award-winning architectural firm specializing in healthcare and laboratories, with a sub-specialty in the design and construction of USP 797-compliant pharmacy facilities. Over the last three years, the firm has designed over (20) usp 797-compliant pharmacies. For more more information about pharmacy design and construction, please contact:

William N. Bernstein, AIA
Principal
Bernstein & Associates, Architects - PLLC
59 West 19th Street - 6A New York, NY 10011
Office: 212.463.8200 Cell: 917.747.2924 Fax: 212.463.9898
Email: wb@bernarch.com
www.bernarch.com