David
Muchemu has authored an article of interest for Controlled Environments. The
article concerns the essential requirements for validating a cleanroom and
certifying it to a particular class before it is used for process operations.
The
introduction reads:
“A
cleanroom is a modular environment in which the following environmental factors
are kept under control; temperature, airborne particulates, microbes, relative
humidity, differential pressure, and air flow.
Cleanroom
Validation is performed for a variety of reasons. To ensure that the design of
the facility is fit for its intended purpose; to ensure that the facility,
equipment, and environment meets User Requirement Specifications (URS); to
ensure that the facility, equipment, and environment meet defined regulatory
requirements; to ensure that the facility, equipment, and its environment
function together as a system to meet defined standards.
Cleanrooms
are validated and then certified to a chosen class of ISO 14644-1. Each class
of ISO14544-1 has its unique requirements that must be made for a facility to
be classified in the specified classification.”
Posted by Tim Sandle
No comments:
Post a Comment
Pharmaceutical Microbiology Resources