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
Showing posts with label USP 797 Questions/Answers. Show all posts
Showing posts with label USP 797 Questions/Answers. Show all posts
Sunday, August 2, 2009
Saturday, January 31, 2009
Storage of Chemotherapy Medications
* 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
* 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
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
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
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
Saturday, December 27, 2008
Negative Pressure Rooms Required in Low Volume Hazardous Compounding Rooms
* 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.
* 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
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.
* 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.
Monday, November 24, 2008
Q & A on usp 797: Sink in Anteroom
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
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
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
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
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
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
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
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
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
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
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
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
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