ISO 14644 and Cleanrooms

Cleanrooms have been part of Life Science manufacturing for a long time, for example a device, pharmaceutical or a pharmacy clean room all have specific design requirements to make sure that they add value. As cleanrooms have evolved in parallel with the manufacturing processes and techniques themselves, it is difficult to evaluate in isolation, just…

This white paper describes the changes outlined in the Draft International Standard (DIS) editions of ISO 14644-1 and ISO 14644-2 relating to clean room & clean air device classifications: ISO 14644–1 and ISO 14644–2. When the standards are published towards the end of 2012, changes will have to be made to the way every cleanroom and…