Both the USA cGMP 1 and EU GMP 2 dictate that cleanroom classification must be carried out according to ISO 14644-1. The version of this ISO standard released in 1999 4 was rewritten by a group of ...

Possible cross-contamination issues should be eliminated at the early stage of the project. The project sponsor should ensure that all relevant personnel from the production, quality control, ...

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 Clean Room, or cleanroom, is a laboratory environment that ensures that airborne particles are maintained at a very low concentration. This room is isolated, actively cleansed, and prevented from ...