Knowledge Category: Air
Cleanroom Design Questions & Answers
This FAQ paper is a follow up to the webinar, ā3rd Annual Cleanroom Design and Engineering Forumā presented by Anna Campanella. Many thoughtful questions were asked about non-viable particle counting requirements in cleanrooms and sampling placement pertaining to process design. Questions submitted during and after the webinar are answered by Anna Campanella, below. If you have any additional queries for our experts, submit them directly here.
Understanding ISO 21501-4
ISO 14644-1:2015 introduces the need for particle counters calibrated to ISO 21501-4. The calibration methods assure data accuracy and repeatability. The methods outlined in ISO 14644 and ISO 21501-4 represent an important step in more accurate evaluations of cleanroom contamination and improved process control.
Process Analytic Technologies (PAT) and Non-Viable Particle Counting
Pharmaceutical manufacturing environments have traditionally seen particle counting as a burden required to demonstrate compliance to a cleanroom standard. Now, however, Process Analytical Technologies (PAT) changes the focus to be on the final quality of the product…