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- 21 CFR 1271 for Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P)
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single particle light interaction methods - ISO Cleanroom Class Particle Monitoring
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21 CFR 1271 for Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P)
For specific questions please contact Mark Hallworth at mhallworth@pmeasuring.com or 303.443.7100.
Papers
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The FDA requires human cell, tissue, and cellular and tissue-based product establishments to follow the current Good Tissue Practice (GTP), which governs the methods used in, and the facilities and controls used for, the manufacture of human tissue and cellular and tissue-based products. The 21 CFR Part 1271 regulation was enforced as of May 25, 2005... 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 (380.3 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. |
Products
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Lasair® III Particle CounterThe Lasair® III particle counter is ISO 21501 compliant through the use of an on-board PHA. Its large IR touch screen with simplified user interface makes the new standard for particle counters. |
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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. |
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