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When performing process validation for a new preformed sterile barrier system across multiple sealers (9) with little rationale for equivalence, how do I reduce sample size for PQ lot runs?
Last Updated On May 15, 2008
The different sealers need to be evaluated for similarities, not necessarily absolute equivalence. For example, it may be possible to group heated bar sealers together, impulse sealers together, and/or band sealers together. It is likely that the IQ and OQ work will demonstrate that there are significant similarities between some of the sealers that could be used to rationalize grouping them together for validation runs. Depending on the sealers involved you should be able to reduce the number of groups tested to something much less than nine. Just remember to document your rationalization for doing so.