Considerations and Steps for Building a Contamination Control Strategy (CCS) Frequently Asked Questions
This FAQ paper is a follow-up to the webinar, “Considerations and Steps for Building a Contamination Control Strategy” presented by Anna Campanella and Ugonna Omeronyé. 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 and Ugonna Omeronyé, below. If you have any additional queries for our experts, submit them directly here.
Some questions covered in this paper are
- From your experience, does CCS risk management using FMEA depend on historical data or experience and expectations?
- What is the air classification of a vial sealing/capping area and what is the right location for a non-viable counter?
- How far can airborne sensors be placed from the critical measuring point and how can we know that our points actually give us a good aseptic representation of the cleanroom?
- Many more…..