This guide, which was built from the Beginner Guide to Particle Counting, helps those new to particle counting get comfortable with the basic details and concepts around monitoring and controlling contamination.
The recent revision of ISO 14644-1:2015 has introduced several changes for cleanroom classification and monitoring guidelines. This paper will highlight the major changes in the new ISO 14644-1 compared to the previous version and the possible impact on the Pharmaceutical EU GMP Annex 1 and FDA Aseptic Processing Guideline.
Over the last five years, the ISO Technical Committee 209 has been working on the revision of the basic airborne cleanliness classification, 14644-1 and -2.
Learn about traditional 5.0 and 0.5 μm Particle limit expectations for GMP.
Viable air monitoring is a crucial part of an environmental monitoring program in pharmaceutical manufacturing. The absence of microbial contamination is considered a critical quality attribute due to its potential to dramatically impact, directly or indirectly, the safety and/or the efficacy of the drug product. It has been many years since common viable air monitoring methodologies have been introduced and become standard. It is well documented that traditional methods are insensitive. Singular results only provide an indicator of cleanroom status, and very often no direct correlation between number of organisms and product contamination risks are found.
