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 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 ...

TÜV Rheinland, a global leader in independent testing and certification, has enhanced its Clean Room Validation Services to meet stringent sterility and contamination-control requirements across ...

Clean rooms are critical areas in bio/pharma facilities, and it is essential that users are responsible for their care and upkeep, and familiarize themselves with the relevant regulations. Clean rooms ...

Standard environmental monitoring with a cart of equipment that collects samples at pre-established locations of the cleanroom is a process that many have grown accustomed to performing. These ...

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 ...

Today’s standards define airborne particle monitoring in units of particles per cubic meter (particles/m 3). These standards tend to require sampling an entire cubic meter (1 m 3) to establish an ...