Particle Count Cleanroom Certification versus Routine Particle Monitoring and current GMP requirements

Cleanroom Certification is a process of validation. This validation process certifies that the Cleanroom operating conditions meet the intended design parameters. Room Particle Counts are tested using a Portable Particle Counter sampling at a defined volume at evenly spaced test locations around the cleanroom based on current Cleanroom Standards. The most accepted and widely used Cleanroom standard is ISO 14644-1 (2015) Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration.

Mar 14, 2022