Recent statements made by European regulators to justify the pre-use/post-sterilization integrity test (PUPSIT) require clarification.
The statements indicated that filter manufacturers have weaknesses within their quality control functions that may create risks, thereby,
requiring a pre-use, post-sterilization integrity test (PUPSIT). The statements included:
- Filter manufacturers have no transport qualification and lack
control over the transport of the filter elements shipped
- Filter manufacturers do not control the outsourced gamma
sterilization of their filter units, and, therefore, do not detect
- The quality control of the filter manufacturing processes and
the release criteria are insufficient and weak
- An anecdotal conversation alluded to an experience of a filter
flaw that was masked by blockage of the filter
We believe these statements require substantial clarification.