GMP and cGMP Particle Counting Requirements
Learn about viable and non-viable particle monitoring for cGMP compliance from the papers listed. Find monitoring solutions from the products listed below.
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Papers
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Technical Review: European GMP Annex 1, 2008 edition (709.0 KB) Read this technical summary of the updated particle monitoring recommendations in the 2008 EU GMP Annex 1. This paper discusses why the new Annex was needed, and how to comply. Download above file for full tables and figures, or for overview, see HTML Version. |
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GMP Update Summary - Particle Monitoring To Meet FDA and EU GMP Requirements (592.5 KB) Several changes have occurred that have brought an elevated review of practices with regard to non-viable particle monitoring, specifically the FDA Guideline on Aseptic Manufacture and the EU GMP Annex 1. Download above file for full tables and figures, or for overview, see HTML Version. |
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Particle Monitoring Requirements in Pharmaceutical Cleanrooms (381.5 KB) This paper explains the various microcontamination requirements of pharmaceutical manufacturing, defines a clean manufacturing environment, and shows how to... Download above file for full tables and figures, or for overview, see HTML Version. |
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How Many Particles, How Much Sample Volume? (254.3 KB) How many particles are needed to demonstrate statistical confidence for cleanroom control and how much sample volume is required to see them? Download above file for full tables and figures, or for overview, see HTML Version. |
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EU GMP 5 µm Particle Limits Advice (860.1 KB) There is a common industry misconception that 1m3 particle monitoring should be performed...(download file to continue to learn more) Download above file for full tables and figures, or for overview, see HTML Version. |
Products
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The Lasair III is ISO 21501 compliant through the use of an on-board PHA. Large IR touch screen with simplified user interface makes the new standard for particle counters.
Easy and cost-effective particle sensor to simultaneously monitor particles from multiple locations. Offer a small footprint, unparalleled performance, and superior data transmission capabilities.
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The MiniCapt portable sampler allows the user to move the unit around the clean area to collect microbiological samples and replicates the Lasair particle counter range of products in application. There are two accessories: a compressed gas kit for sampling high-pressure process gases and an isolator kit for remote sampling applications.
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The Air Trace® Viable Particle Sampler uses slit-to-agar technology which provides the ability to predict approximately when the contamination event took place during the sampling process. A remote head and compressed gas kit is available. This is used as the reference method the FDA requires as part of validation.
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When a full monitoring application is required, the AirCapt MP8+ (an integrated PLC controller with SCADA interface and capability of running up to eight remote heads) can be used. This interface fully integrates into standard FMS software and is designed for compatibility with the next generation FacilityNet software. Expansion of the base module allows a second multiple of eight sensor heads to be added to a single PLC controller.
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The DualCapt System combines the particle counting ability of the RNet 510 Particle Sensor with the BioCapt Impactor Head into a single enclosure resulting in a dual-capability viable and non-viable sampling system. This reduces the installation burden many companies see as they migrate to combined system capability.
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