Major pharmaceutical companies are investing in new biologics, most of which will be manufactured using aseptic processing. Continuous non-viable particle monitoring (NVP), when properly configured, provides useful information on changes in the aseptic environment with minute-by-minute updates of count populations and trends, which catch contamination events and thereby identify and quantify risks (i.e. a non-zero result). Both the FDA and EU specifically reference continuous monitoring of NVP during aseptic processing for the purpose of real time event detection. This paper gives an overview of the trends, best practices and tips to consider when setting up an NVP monitoring system.
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- Get a head start on the best practices and trends to set up a non-viable particle monitoring system
- Get details of the key considerations when implementing an NVP system
- Get started on putting together a User Requirements Specification
- Get useful tips on starting early rather than bolting on an NVP system
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