USP 797 Consulting on New Prefab Pharmacy Cleanrooms

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

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

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

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

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

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

[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.