This FAQ paper is a follow up to the webinar, “3rd Annual Cleanroom Design and Engineering Forum” 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.
Establishing and maintaining cleanroom performance of aerosol particles in a cleanroom often requires the use of multiple particle counters with varying design parameters and display settings. Commonly, cleanroom personnel employ the use of multiple optical particle counters (as defined in ISO 14644-1) to report an array of airborne particle counts. This paper is a summary of the basic methods cleanroom personnel may use to ensure that the data that is reported by different aerosol particle counters can be compared effectively. This is accomplished by making sure differences are understood and appropriate data conversions can be made to make meaningful comparisons.
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…
With the release of the new EU GMP Annex 1, a review of current practices is required to ensure that the installed monitoring system, chosen to meet the needs of Annex 1, complies with the requirements. This chapter will review the needs of Annex 1 with systems designs currently being installed.
