[change country]- 21 CFR 1271 for Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P)
- 21 CFR Part 11 Compliance
- Airborne Particle Counters
- DI Water / UPW Particle Monitoring
- GAMP® Requirements and Solutions
- GMP and cGMP Particle Counting Requirements for EU and FDA Regulations
- ISO 14644 Cleanroom Classes for Particle Monitoring
- ISO 21501: Determination of Particle Size Distribution
single particle light interaction methods - ISO Cleanroom Class Particle Monitoring
- ITRS Roadmap Solutions
- Microbial
- Monitoring Particles in Injectables for USP 788 and EP6
- NEW INFORMATION GUIDES
- NEW INFORMATION GUIDES
- Optical Haze Blurs the Bottom Line
- Particle Counters for Gas Applications
- USP 797 Particle Monitoring Solutions
- WET PROCESS CONTROL
- processcontrols
Monitoring Particles in Injectables for USP 788 and EP6
Testing of finished injectable solutions requires compliance to both the USP 788 and, where European regulation need to be met, EP6. See below to learn about requirements from the papers and find solutions from the products shown.
For further information on USP 788, or for specific pharmaceutical monitoring questions, please contact Mark Hallworth, Pharmaceutical Specialist, at 303.443.7100 or mhallworth@pmeasuring.com
Papers
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Particle Counters for Injectable Solutions, 2007 USP 788 Update (244.3 KB) Learn about the requirements laid out by US (USP), European (EP), and Japanese (JP) Pharmacopoeia standards, including the most recent USP 788 (April 2007), EP 5.1 and JP 15 release information. These standards demand that... Download above file for full tables and figures, or for overview, see HTML Version. |
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Basic Guide to Particle Counters and Particle Counting 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. |
Products
SamplerSight Particle Monitoring SoftwareProvides a comprehensive view of batch-based liquid particle counter information with histogram, time plot, and tabular data. |
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. |
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. |
Information on this website is subject to change without notice.
