As part of the ISO periodic review cycle, ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness is being revised. ISO TC209 Working Group 01, an ...

This is especially relevant given the recent revision to EU Annex 1 – Manufacture of Sterile Medicinal Products (2022). The Technical Report (TR) outlines how particle counters are used to monitor and ...

OCS Indonesia has achieved ISO 14644-1:2015 certification for Air Particle Testing, becoming the only facilities management provider in the region to hold this accreditation. The certification ...

This webinar, presented by one of the US members to the international revision group, discusses how the newly-revised ISO 14644-1 and -2 standard for counting airborne particles in cleanrooms may ...

Pharmaceutical products are produced to meet strict standards for effectiveness and quality. Every aspect of quality is assessed, taking into account the risks associated with the method of delivery ...

Revised versions of ISO 14644 adopt changes to sampling procedures and monitoring plans for cleanrooms. The International Organization for Standardization (ISO) published the long-awaited revisions to ...

A technician at Microtest performs bioburden testing using the aseptic technique. There are no commonly accepted levels of environmental bioburden. Industrial sterilization and contamination control ...

Thermo Fisher Scientific TSX and TDE Series ultra-low freezers are tested according to ISO 14644-14 and designated ISO Class 5.5; operational; 0.1 μm, 0.2 μm, 0.3 μm, 0.5 μm, 1.0 μm, contributing to ...

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones. Revised versions of ISO 14644 Parts 1 and 2 introduce changes ...