3rd Annual Cleanroom Design and Engineering Forum Frequently Asked Questions
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.
Some questions covered in this paper are
- For the ORABS system filling machine, what is the correct sequence of activities? Installation of gloves or keeping microbial monitoring plate inside the filling machine cabinet?
- What is the efficiency of counters able to monitor viable and particle concurrently?
- According to the newest Annex 1 draft, the CNC rooms should be specified as ISO 8, ISO 9 or lower. Does that mean we should qualify them as part of the cleanroom? If so, which test qualification should be used?
- Many more…..