Advanced guide to particle technology
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.