USP 797 Particle Monitoring Solutions
As of January 1, 2004, pharmacies compounding sterile preparations have been required to monitor their facilities and processes to standards mandated by USP 797. However, between the complicated language of the regulation and the expense of meeting some of the requirements, many compounding pharmacies are still not in compliance. We provide solutions to both USP 797 problems.
Go to the bottom of this page to read USP 797 Frequently Asked Questions (FAQs), or submit your own question.
Papers
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Summary for USP 797 Operating Docs - Complete Document provided with Handilaz Mini Purchase (64.6 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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Quick Steps to Meet USP 797 Compliance (203.5 KB) The current USP 797 requirements for particle monitoring can be summarized as to prove that a cleanroom, or clean device, meets the defined ISO 14644-1 classifications. (Download paper to learn more) Download above file for full tables and figures, or for overview, see HTML Version. |
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USP 797 Particle Monitoring (603.8 KB) Download above file for full tables and figures, or for overview, see HTML Version. |
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Particle Counters for Cleanroom Monitoring and Certification (381.5 KB) This paper explains the various microcontamination requirements of pharmaceutical manufacturing, defines a clean manufacturing environment, and shows how to certify a cleanroom. Special examples of a sterilizing tunnel and lyophilizer are included. Learn more now... Download above file for full tables and figures, or for overview, see HTML Version. |
WEBCAST: The Plain Truth About USP 797This webcast can be attended live on January 30, 2007, or can be viewed on demand until Jan 30, 2008. |
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Basic Guide to Particle Counters and Particle Counting (8.4 MB) This overview of particle contamination starts by discussing sources of contamination and monitoring technologies available, and continues by discussing various... Download above file for full tables and figures, or for overview, see HTML Version. |
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