Using Data from Cleanroom Microbial Monitoring
This FAQ paper is a follow up to the webinar, Leveraging Microbial Contamination Monitoring Data for Actionable Insights to Meet and Exceed the Auditor’s Expectations.
Some questions covered in this paper are:
What statistical methods do you suggest for evaluation of environmental monitoring data?
Monitoring data starts out as raw counts and is typically normalized by dividing by the sampling volume. There are no specific requirements for how your data should look, but it needs to be in a form that can be routinely analyzed by Quality Control. Often, this involves a normal distribution using mean and standard deviations with confidence levels and intervals.
Does Pharma 4.0 allow for comparative study between particle size monitoring and microbiological data?
Several studies have been performed and published. See our paper on Comparing Microbiological Air
Monitoring Techniques for Critical Environments.
How is monitoring frequency determined? What about after qualification?
Current good manufacturing practices (cGMPs) state monitoring frequency should be based on risk assessment, which is an evaluation of contamination risk to your product. Auditors expect all controls to be scientifically justified and accurately demonstrate the state of environmental conditions for cleanrooms, airlocks and pass-throughs used for material and equipment transfer.
How is the BioCapt Single-Use microbial impactor packaged? Can it be used in an isolator?
The BioCapt Single-Use microbial impactor is quadruple-bagged to preserve sterility of the product, and can be added
seamlessly to isolators and other microenvironments.
Learn more… Complete the form to download the full paper.
