* 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
Saturday, January 31, 2009
Thursday, January 29, 2009
Purchase of Air Sampling Equipment and Performance of ISO Air Testing
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
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
Friday, January 23, 2009
New Article on Design of Pharmacy to Conform with USP 797 (2008 version)
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
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
Monday, January 19, 2009
EMSL analytical offers analysis for USP 797 samples
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.
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.
Wednesday, January 14, 2009
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.).
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
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
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.
Saturday, January 10, 2009
Storage of Refrigerator in Anteroom
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
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
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