Cleanroom standards

Microbiology books

As an update for Pharmaceutical Microbiology readers, here is a list of the published ISO 14644 cleanroom series of standards, including those in development.

ISO 14644 consists of the following parts, under the general title Cleanrooms and associated controlled environments:

Part 1: Classification of air cleanliness by particle concentration

Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1

Part 3: Test methods

Part 4: Design, construction and start-up

Part 5: Operations

Part 6: Vocabulary

Part 7: Separative devices (clean air hoods, glove boxes, isolators, mini-environments)

Part 8: Classification of air cleanliness by chemical concentration (ACC)

Part 9: Classification of surface cleanliness by particle concentration

Part 10: Classification of surface cleanliness by chemical concentration

The following part is under preparation:

Part 12: Classification of air cleanliness by nanoscale particle concentration

Readers should also note that cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications will form the subject of a future Part 13.

Posted by Tim Sandle