Regulatory Archives

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cleanroom classification cards for Annex 1 and ISO 14644 and more

Cleanroom Compliance Quick-Reference Cards

Simplify cleanroom compliance with these free, downloadable reference cards from Particle Measuring Systems. Designed for cleanroom operators and quality professionals, the cards summarize key ISO 14644-1 and EU GMP Annex 1 requirements, including particle limits, microbial guidelines, and cleanroom classifications.

Use them to stay compliant, support audits, and train your team.

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Microbial Contamination Monitoring and cleanroom data management Cleanroom Classification v. Cleanroom monitoring

Contamination Control Strategy in the Pharmaceutical Industry

Particle Measuring Systems (PMS) recently hosted a webinar Contamination Control Strategies for Innovation and Regulatory Compliance to explain how the implementation of a CCS attempts to address the varied causes of contamination and compromised sterility. Download the paper to get answers to all questions asked.

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Particle Contamination in High-Purity Process Chemicals

ISO 14644 – Technical Report 21: 2023

This paper written by Mark Hallworth, one of the ISO TR 14644 21 committee members, discusses why this new technical report was released, the implications, and next steps for practical application. Complete with explanatory diagrams and a decision tree.

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Maintaining Quality in Stem Cell Products: Quality Control Considerations (Series Part 3 of 4)

Bacteria to Consider for the Growth Promotion Test: Should Anaerobic Cultures Be Included?

The purpose of the Growth Promotion Test (GPT) is to determine the appropriateness of the culture media to be used in environmental monitoring sampling. The medium is challenged with a small number of microorganisms to assure the nutritive properties, functionality and media quality are adequate for the detection and enumeration of microbial contaminants.

Knowledge Category: Regulatory

Cleanroom Compliance Quick-Reference Cards

Contamination Control Strategy in the Pharmaceutical Industry

ISO 14644 – Technical Report 21: 2023

Bacteria to Consider for the Growth Promotion Test: Should Anaerobic Cultures Be Included?

Without measurement there is no control®

Cleanroom Compliance Quick-Reference Cards

Contamination Control Strategy in the Pharmaceutical Industry

ISO 14644 – Technical Report 21: 2023

Bacteria to Consider for the Growth Promotion Test: Should Anaerobic Cultures Be Included?

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Without measurement there is no control®