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 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 Monitoring (441.3 KB) 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
The APSS-200 syringe sampling system is designed to size and count suspended particles in a wide range of liquids. This system meets and exceeds all current USP 788 requirements and is engineered to adapt to future regulatory changes. The APSS-200 system consists of an LS-200 syringe sampler, a LiQuilaz® particle counter, and SamplerSight-Pharma software, which meets FDA 21 CFR Part 11 "Electronic Records and Signatures" rulings.
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Provides a comprehensive view of batch-based liquid particle measurement systems information with histogram, time plot, and tabular data.
Services
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