Knowledge Category: Air
Portable Particle Monitoringin Pharmaceutical Cleanrooms
All pharmaceutical and biotech products must be manufactured in accordance with the current Good Manufacturing Practice (cGMP) regulations. Environmental monitoring of these pharmaceutical manufacturing areas meets the requirement for contamination control of an environment, which is essential in defining clean manufacturing and demonstrating the necessary controls are working.
Cleanroom Classification for Pharmaceutical Applications
Pharmaceutical products are manufactured to meet exacting standards of both efficacy and quality. All aspects of quality are reviewed considering the risks associated with the delivery method (injected, ingested etc.) and the manner in which they were produced (aseptic, terminally sterilized, or under lesser controlled conditions). This paper looks at two parts of that process: the quality of the environment in which the product is manufactured and the standards that surround the particle concentration limits that determine what a controlled environment consists of.
A Practical Guide to Aerosol Particle Counter Matching
A common question related to aerosol particle counters is how well particle counting results should match each other. New airborne particle counters added to an existing fleet won’t always match the counts of the old. This could be as a result of different manufacturer’s, but even when the particle counters are supplied by the same manufacturer, it is not uncommon for variation to exist. In this short paper, we provide a practical guide for the expectations one should have when comparing particle count data from similar and dissimilar instruments.