Answers to questions asked during the webinar “Considerations and Steps for Building a Contamination Control Strategy”. Many questions were asked about contamination monitoring requirements in cleanrooms and sampling placement pertaining to process design.
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.
This FAQ paper is a follow up to the webinar, “ISO EN 17141 & ISO 14968 Overview”.
Some questions covered in this paper are
Is there any guidance or requirement that applies in a quality control laboratory? Or are they only applicable for cleanrooms in manufacturing areas?
How do I check the particles in nitrogen gas, and what are the specifications?
In May 2021, a revision to USP <1788> Methods for Determination of Subvisible Particulate Matter was published in order to provide clarification and support of the information given in chapters USP <788> Particulate Matter in Injections, USP <789> Particulate Matter in Ophthalmic Solutions, and USP <787> Sub-visible Particulate Matter in Therapeutic Protein Injections. While the previous version of USP <1788> only covered the testing requirements for Optical Light Obscuration testing and Microscope testing, the revision expands the scope of testing requirements to include newly viable technologies such as Flow Imaging and new therapeutic protein solutions. Particle Measuring Systems’(PMS) APSS-2000 testing system still fully complies with the requirements for use in the testing of solutions in the Normative Chapters and revised General Chapters.
