The recent revision of ISO 14644-1 and-2 has introduced several changes for cleanroom classification and monitoring guidelines. This paper highlights the major changes in the new ISO 14644-1 compared to the previous version, as well as the possible impact on the Pharmaceutical EU GMP Annex 1 and FDA Aseptic Processing Guideline.
Archives for February 2016
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Particle Measuring Systems
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NEW MICROBIAL TESTING TECHNOLOGY FOR CLEANROOMS ANNOUNCED BY MOCON, PARTICLE MEASURING SYSTEMS
Minneapolis (February 3, 2016) – Cleanroom operators will now be able to detect the presence of extremely low levels of microbial cells on surfaces much faster than traditional solutions. The capability is a result of a global marketing agreement between MOCON, Inc. (NASDAQ: MOCO) and Particle Measuring Systems (PMS).