Aseptic Filling Validation Media Fill Studies

4 ASEPTIC FILLING VALIDATION (MEDIA FILL STUDIES) [Pg.151]

The protocol will include acceptance criteria for sterility assurance level and growth promotion. [Pg.151]

Also included will be details of data collection, growth promotion sampling, environmental and personnel monitoring schedule, personnel movement documentation, incubation time and temperature, etc. [Pg.151]

Upon successful completion (end-point contamination level of not more than 0.1%) of three (3) consecutive media fills for the vial/stopper combination and ampoules, the aseptic process will be considered validated. [Pg.151]

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