Media Fills in Validation of Aseptic Processes

The Guideline on Sterile Drug Products Produced by Aseptic Processing FDA, 1987 refers to media fills as an acceptable method of validating the aseptic assembly process. By 1994, the Guideline to Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products FDA, 1994 said that specifications for media fills should be among the information submitted in support of sterility assurance for products manufactured by aseptic...

Periodic Media Fills in Routine Operation

It is unlikely that any responsible regulatory body would tolerate a frequency of less than twice a year for periodic media fills. Media fills are probably the most sensitive method of detecting unexpected sources of process contamination. The regulatory standpoint coming from the principle of patient protection is that if unexpected process contamination occurs in a media fill, and is considered sufficient to compromise the sterility of past product, they would expect market withdrawal....

Environmental Monitoring and Media Fill Observation

Microbiological monitoring is a potential source of contamination that must be simulated in media fills, as one of the best ways of diagnosing the source of contamination arising in media fills. It should always be assumed that management is anxious to know what, where and why media fill contamination has arisen, in order to decide on appropriate corrective and preventive actions and improve their processes. For this reason it is advisable to have intensive microbiological monitoring over the...