Viable and non viable count observation during batch filling.batch

During regular filling (sterile unit) i found viable and NVPC count what i have to do with that batch shall i reject or accepct the batch.can any one briefly explain it.

You should not reject the batch unitll it fails in sterility or bioburden test.

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During working condition Nonviable particle count Limit change as compare to rest .
Rejection only if sterility or pyrogen test fail.


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