usp797.org newsletter
www.usp797.org is a privately-owned website developed to aid understanding of the USP 797 regulation
October 2009
IN THIS ISSUE
usp797.org - Vendor News
- "Forward Thinking Pharmacy Design Boosts Patient Safety, Efficiency and Aesthetics"
- "CT International’s Bonric Manufacturing Facility in Malaysia is Pleased to Announce That it Has Been Certified ISO 14001"
- "EMLab P&K Supports Clients After Recent Flooding"
USP797 Seminars Being Offered
usp797.org - Questions and Answers
usp797.org - vendors
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usp797.org - Vendor News
10/08/09: "Forward Thinking Pharmacy Design Boosts Patient Safety, Efficiency and Aesthetics"
A new hospital pharmacy design, for the Santa Barbara Cottage Hospital, has many goals, but the number one goal, from the beginning, was always clear: patient safety. The director of the pharmacy, Allan Cohen, PhD --- who signs all of his emails with the phrase “Patient Safety is Contagious – Pass It On!” --- and the Assistant Director, Sergio Castro, made sure that patient safety played a central role in the myriad decisions made in the planning and design process for the new pharmacy.
For full text of the article, go to: http://usp797.org/VendorNews-PharmacyDesignBoostsPatientSafety.htm
10/05/09: "CT International’s Bonric Manufacturing Facility in Malaysia is Pleased to Announce That it Has Been Certified ISO 14001"
The ISO 14001 standard requires that an organization put in place and implement a series of practices and procedures that, when taken together, result in an environmental management system (EMS).
For full text of the article, go to: http://www.usp797.org/VendorNews-CTI-BonricFacilityCertifiedISO14001.htm
10/02/09: "EMLab P&K Supports Clients After Recent Flooding"
You are probably aware of the recent flooding that took place in Georgia. In fact, many of EMLab P&K's clients are working hard to assist those in Georgia and the Southeast region. Flooding increases the need for environmental testing due to potential health risks associated with contaminated water from sewage and various waterborne agents. As a result, residents and property owners must deal with the potential for bacterial contamination, mold growth, sewage contamination and other environmental health concerns caused by flooding and water damage.
For full text of the article, go to: http://usp797.org/VendorNews-EMlabSupportsClients.htm
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USP797 Seminars Being Offered
Aseptic Processing and Compliance Tools for USP <797>
Fundamentals of Bioassay Practices
For more info go to: http://www.usp797.org/Seminars.htm
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usp797.org - Questions and Answers (latest Q&A posted on site)
RJLG Question 15: I have a question regarding the preparation of chemotherapy. I have a negative pressure glove box that is vented to the outside. It is currently in the same room as my positive pressure glove box. If I have verification from the manufacturer that the glove box does not need to be in a clean room--do I need to place the chemo glove box in a negative pressure room? Could I place it in a separate room without negative pressure. If my room does not have negative pressure--where is the appropriate area to store my chemo meds? I would appreciate any information you can send.
RJLG Answer 15: First, your glove box which is used to prepare hazardous drugs must meet the definition of a compounding aseptic isolator (CAI) or compounding aseptic containment isolator (CACI) and must be physically separated from other preparation areas (i.e., in a different room). If the CAI or CACI meets the conditions of the “Placement of Primary Engineering Controls” section of USP797 that allow usage outside of an ISO Class 7 buffer area or clean room, the room must be negative pressure (minimum 0.01 inch water column and 12 air changes per hour). If only a low volume of hazardous drugs are prepared and a closed system transfer device (CSTD) is used within the CAI or CACI, the room does not need to be negative pressure.
Regarding hazardous drug storage, please refer to RJLG Questions 12 and 14 in this Q&A section of the USP797.org website.
Answer provided as a courtesy to USP797.org by Matthew Zock of the RJ Lee Group, Inc. (RJLG). Note: Neither RJLG nor USP797.org assumes any liability for the use or interpretation of this information. Please con consult your pharmacy consultant prior to taking any actions in your pharmacy.
For more USP 797 Questions and Answers, go to: http://www.usp797.org/Questions_and_Answers.htm
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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
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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
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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
Showing posts with label USP 797 Newsletter. Show all posts
Showing posts with label USP 797 Newsletter. Show all posts
Tuesday, October 13, 2009
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
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USP797 Seminars Being Offered
Aseptic Processing and Compliance Tools for USP <797>
Fundamentals of Bioassay Practices
For more info go to: http://www.usp797.org/Seminars.htm
--------------------------------------------------------------------------------
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)
Saturday, February 14, 2009
USP 797 Newsletter (February 2009 edition)
This is a summary of the February 2009 edition of the USP 797 Newsletter:
(produced by the privately-owned website www.usp797.org)
usp797.org - Vendor News
"EMSL analytical offers analysis for USP 797 samples", 01/14/09
"EMSL Analytical, a leading provider of laboratory services, recently announced they have begun to analyze samples for USP 797. Issued by the US Pharmacopoeia (USP), USP 797 regulations provide a standard for all pharmacies that prepare ‘compounded sterile preparations’ (CSPs). Most pharmacies must comply with this regulation and many hospitals that operate pharmacies meeting the same criteria are also affected..."
For the full article go to: http://usp797.org/VendorNews-EMSLAnalyticalOffersAnalysisforUSP797Samples.htm
"New Article on Design of Pharmacy to Conform with USP 797 (2008 version)", 01/31/09
"Bernstein & Associates, Architects is pleased to announce the publication of a new article about design of pharmacies to conform to the 2008 version of USP 797. The article has been published in the February 2009 edition of Hospital Newspaper. The article discussed the latest edition of USP 797, and how pharmacists and pharmacy managers should plan, design and construct their pharmacies to conform to USP 797..."
For the full article go to: http://usp797.org/VendorNews-DesignofaUSP797CompliantPharmacy.htm
________________________________________
USP797 Seminars Being Offered
• Aseptic Processing and Compliance Tools for USP <797>
• Practical Application of USP's General Chapter <797>
For more info go to: http://www.usp797.org/Seminars.htm
________________________________________
usp797.org - Questions and Answers (latest Q&A posted on site)
• RJLG Question 12: If chemotherapy medications are stored in the negative pressure cleanroom, how are refrigerated chemotherapy meds supposed to be stored since refrigerators should not be placed in the clean room? Do we have to build a separate negative pressure area for the refrigerator?
• RJLG Answer 12: Although a separate negative pressure room for bulk storage of all hazardous drugs would be ideal, storage in a negative pressure room is recommended by USP797 but not a current requirement.
All hazardous drugs must be stored separately from other inventory. Hazardous drugs should only be stored in the negative pressure buffer room if they are removed from their cartons and decontaminated in the ante area using appropriate procedures and personal protective equipment, and if the stored quantities are required for supporting your compounding operation. Excessive or bulk storage in the buffer room should be avoided.
Regarding your separate refrigerator for refrigerated hazardous drugs, USP797 states, “Placement of devices in ante areas and buffer areas is dictated by their effect on the designated environmental quality of atmospheres and surfaces, which shall be verified by monitoring.”
Answer provided as a courtesy to USP797.org by Matthew Zock of the RJ Lee Group, Inc. (RJLG). Note: Neither RJLG nor USP797.org assumes any liability for the use or interpretation of this information. Please consult your pharmacy consultant prior to taking any actions in your pharmacy.
For more USP 797 Questions and Answers, go to: http://www.usp797.org/Questions_and_Answers.htm
________________________________________
usp797.org Vendors
Architects:
Bernstein & Associates, Architects
Project Management:
Empire Projects, Inc.
Analytical Testing:
EM Lab P&K
EMSL Analytical Inc.
Cleaning Products / Contamination Control:
Acute Care Pharmaceuticals
Attentus Medical Sales, Inc.
Berkshire Corporation
Blue Thunder Technologies, Inc.
Contec, Inc.
Decon Labs Inc.
Dycem's CleanZone
Lymtech Scientific
Medical Specialties Distributors, LLC(MSD)
Techniglove International
Cleanroom Design/Build Companies:
TAC Americas
TCA
Compliance Action Plans:
Clinical IQ, LLC
Global Quality Alliance, LLC
Lasco Services
Quality Solutions, LLC
RJ Lee Group, Inc.
Environmental Monitoring:
AES-Chemunex, Inc.
Biotest
Controlled Environment Testing Association
Lighthouse Worldwide Solutions
RJ Lee Group, Inc.
Technical Safety Services, Inc.
Software:
Simplifi 797
Testing & Certification
Aemtek, Inc.
Certco, Inc.
Technical Safety Services, Inc.
USP 797 Related Products:
The Baker Company
CriticalPoint, LLC
EMSL Analytical Inc.
Esco Technologies
Germfree LaboratoriesIncorporated
Isotech Design
RJ Lee Group, Inc.
Trion, Inc. Air Purification Systems
www.usp797.org is a privately-owned website.
For more information about usp 797, go to the usp 797 website: www.usp797.org. Or go to the USP website itself at www.usp.org.
(produced by the privately-owned website www.usp797.org)
usp797.org - Vendor News
"EMSL analytical offers analysis for USP 797 samples", 01/14/09
"EMSL Analytical, a leading provider of laboratory services, recently announced they have begun to analyze samples for USP 797. Issued by the US Pharmacopoeia (USP), USP 797 regulations provide a standard for all pharmacies that prepare ‘compounded sterile preparations’ (CSPs). Most pharmacies must comply with this regulation and many hospitals that operate pharmacies meeting the same criteria are also affected..."
For the full article go to: http://usp797.org/VendorNews-EMSLAnalyticalOffersAnalysisforUSP797Samples.htm
"New Article on Design of Pharmacy to Conform with USP 797 (2008 version)", 01/31/09
"Bernstein & Associates, Architects is pleased to announce the publication of a new article about design of pharmacies to conform to the 2008 version of USP 797. The article has been published in the February 2009 edition of Hospital Newspaper. The article discussed the latest edition of USP 797, and how pharmacists and pharmacy managers should plan, design and construct their pharmacies to conform to USP 797..."
For the full article go to: http://usp797.org/VendorNews-DesignofaUSP797CompliantPharmacy.htm
________________________________________
USP797 Seminars Being Offered
• Aseptic Processing and Compliance Tools for USP <797>
• Practical Application of USP's General Chapter <797>
For more info go to: http://www.usp797.org/Seminars.htm
________________________________________
usp797.org - Questions and Answers (latest Q&A posted on site)
• RJLG Question 12: If chemotherapy medications are stored in the negative pressure cleanroom, how are refrigerated chemotherapy meds supposed to be stored since refrigerators should not be placed in the clean room? Do we have to build a separate negative pressure area for the refrigerator?
• RJLG Answer 12: Although a separate negative pressure room for bulk storage of all hazardous drugs would be ideal, storage in a negative pressure room is recommended by USP797 but not a current requirement.
All hazardous drugs must be stored separately from other inventory. Hazardous drugs should only be stored in the negative pressure buffer room if they are removed from their cartons and decontaminated in the ante area using appropriate procedures and personal protective equipment, and if the stored quantities are required for supporting your compounding operation. Excessive or bulk storage in the buffer room should be avoided.
Regarding your separate refrigerator for refrigerated hazardous drugs, USP797 states, “Placement of devices in ante areas and buffer areas is dictated by their effect on the designated environmental quality of atmospheres and surfaces, which shall be verified by monitoring.”
Answer provided as a courtesy to USP797.org by Matthew Zock of the RJ Lee Group, Inc. (RJLG). Note: Neither RJLG nor USP797.org assumes any liability for the use or interpretation of this information. Please consult your pharmacy consultant prior to taking any actions in your pharmacy.
For more USP 797 Questions and Answers, go to: http://www.usp797.org/Questions_and_Answers.htm
________________________________________
usp797.org Vendors
Architects:
Bernstein & Associates, Architects
Project Management:
Empire Projects, Inc.
Analytical Testing:
EM Lab P&K
EMSL Analytical Inc.
Cleaning Products / Contamination Control:
Acute Care Pharmaceuticals
Attentus Medical Sales, Inc.
Berkshire Corporation
Blue Thunder Technologies, Inc.
Contec, Inc.
Decon Labs Inc.
Dycem's CleanZone
Lymtech Scientific
Medical Specialties Distributors, LLC(MSD)
Techniglove International
Cleanroom Design/Build Companies:
TAC Americas
TCA
Compliance Action Plans:
Clinical IQ, LLC
Global Quality Alliance, LLC
Lasco Services
Quality Solutions, LLC
RJ Lee Group, Inc.
Environmental Monitoring:
AES-Chemunex, Inc.
Biotest
Controlled Environment Testing Association
Lighthouse Worldwide Solutions
RJ Lee Group, Inc.
Technical Safety Services, Inc.
Software:
Simplifi 797
Testing & Certification
Aemtek, Inc.
Certco, Inc.
Technical Safety Services, Inc.
USP 797 Related Products:
The Baker Company
CriticalPoint, LLC
EMSL Analytical Inc.
Esco Technologies
Germfree LaboratoriesIncorporated
Isotech Design
RJ Lee Group, Inc.
Trion, Inc. Air Purification Systems
www.usp797.org is a privately-owned website.
For more information about usp 797, go to the usp 797 website: www.usp797.org. Or go to the USP website itself at www.usp.org.
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