Microbial Contamination Monitoring and cleanroom data management
Contamination Control Strategies for Innovation and Regulatory Compliance FAQ

Particle Measuring Systems (PMS) recently hosted a webinar titled 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. This easy to read compendium for quick consultation consists of questions received in conjunction with the webinar along with questions from years of supporting our customers in their compliance journey. Questions are answered below by Ugo Omeronye .

Particle Contamination in High-Purity Process Chemicals
ISO/14644 -21:2023 Technical Report 21 / TR 21

The Technical Committee (ISO/TC209) responsible for ISO 14644, the set of Standards governing cleanrooms and associated controlled environments, looked at the need for a new document to aid users in the application of airborne particle counters; especially considering the new revision to EU Annex 1 – Manufacture of Sterile Medicinal Products (2022). The Technical Report (TR) describes the application of particle counters for classification and monitoring to provide sufficient proof that the cleanroom performance both meets the required standard and is demonstrated to be maintained within ‘normal’ operating conditions.