This article outlines guidelines for the testing of high pressure gases utilized in cleanrooms according to the cleanliness limits stated in the FDA cGMP guidelines, the ISO 14644-1 cleanroom ...

Understanding the Requirements for Particle Monitoring in Pharmaceutical Cleanrooms begins with a grasp of the current regulations. The current international standards for defining contamination ...

Modern manufacturing techniques frequently require clean environments designed, constructed, and maintained to facilitate the highest production yields possible while also meeting predictable ...

Ionization systems, installed in medical device manufacturing facilities’ gown-up rooms and product transfer areas have proven to be critical components in reducing particle counts in the associated ...

When using particle counters, many operators are unaware that during conventional manifold sampling, the monitor can undercount the ambient particle concentration. The manifold pump creates an ...