Aseptic filling batch manufacture

Media fill units are treated in the same manner as product and require batch record documentation. All aseptically assembled products manufactured subsequent to a media fill failure are placed in quarantine until acceptable media fill results are obtained. 

Recipe/formulation management Batch manufacturing instruction and records In-process testing Yield calculation Purified water Aseptic filling... 

A quantity of an appropriate sterilized placebo powder is blended with sterile excipients prior to filling (if needed) in a manner similar to the production process being simulated. The medium is passed through the run as though it were an actual product batch, and all routine procedures used in manufacture of a batch are performed. Once the medium has been processed, it is held for a period of time at least equal to that for aseptically produced materials. Any aseptic manipulations performed during and at the end of the hold period should be simulated hold times and product recalculation. 

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