The newly published ISO 14644 part 21 provides clarification on the application of sound airborne particle sampling techniques in support of ISO 14644-1:2015 for classification of cleanrooms and clean zones, and ISO 14644-2:2015 for airborne particle monitoring, to provide evidence of cleanroom performance related to air cleanliness by particle concentration….
Pinpointing a particle source can be a challenge in cleanrooms and laboratory flow equipment where the movement
The role of data quality systems in pharmaceutical organizations has grown faster than any other function during the last 15 years. During this period, a small group dedicated to traditional Compliance grew and expanded to include Quality Experts in areas such as validation, product release, operations, sterility assurance, and other…
Welcome to our USP 1116 questions and answers blog, where Particle Measuring Systems answers commonly asked questions pertaining to the USP 1116 guidance. What guidance is there for non-sterile facilities in regards to CRR (aseptic processing)? It is important to note that <1116> is a “general information” chapter, and as such,…
