Procedure for aseptic filling or media fill validation in pharmaceuticals, frequency, number of runs and interpretation of results.
EQUIPMENT / SYSTEM DESCRIPTION:Location : Manufacturing Area ( Mixing room and filling room)
IDENTIFICATION OF CRITICAL CONTROL MONITORING PARAMETER
Worst Case Consideration:
Frequency, Duration and Number of runs:
Incubation and examination of filled units:
Interpretation of Test Result:
CIP and SIP for LVP line:
Dispensing of Soybean Casein Digest Medium for 750 L batch size:
Batch Preparation 750 L:
Filling And Sealing:
Incubation and Examination of Media Filled Units:
Interpretation of Results:
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