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 Pharmacy Blog Categories
- USP 797 Architects (1)
- USP 797 Articles (4)
- USP 797 Compliance Action Plans (1)
- USP 797 Construction RFPs (1)
- USP 797 Design/Construction (2)
- USP 797 Gap Analysis (1)
- USP 797 Newsletter (3)
- USP 797 Press Releases (3)
- USP 797 Project Management (2)
- USP 797 Questions/Answers (13)
- USP 797 Resources (2)
- USP 797 Seminars (2)
- USP 797 Terms of Use (1)
- USP 797 Vendors News (15)
- Worldwide Healthcare and Design Resources (2)
- Worldwide Pharmacy Design and Operation Resources (2)
Sunday, November 8, 2009
Monday, October 19, 2009
USP 797 Compliance in 2009
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
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
Tuesday, October 13, 2009
USP 797 Newsletter (October 2009)
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
--------------------------------------------------------------------------------
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
---------------------------------------------------------------------------
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 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
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
--------------------------------------------------------------------------------
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
---------------------------------------------------------------------------
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 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
Friday, September 4, 2009
USP797.org Newsletter (July 2009 Edition)
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)
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)
Tuesday, September 1, 2009
New Article on Mail Order Pharmacy Design Published
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
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
Sunday, August 2, 2009
Hazardous Drug Storage in an USP 797 Compliant Environment
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
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.
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.
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.
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