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- USP 797 Particle Monitoring Solutions
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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 (54.4 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. |
Products
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Handheld Particle Counter: Handilaz® MiniThis handheld particle counter provides a low |
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Services
Particle Counter Rental / Leasing OptionsIf you need a particle counter or molecular contamination monitor for a short-term project or troubleshooting, we offer a comprehensive rental program. |
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Pharmaceutical Microcontamination Monitoring ServicesWe have managed over 150 fully integrated system projects worldwide in a variety of applications including: aseptic, tableting, powder fill, and medical devices. |
FAQ's
Information on this website is subject to change without notice.
