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- W67234054 abstract "This chapter examines the primary qualification test for aseptic processing: media simulation trials. Media trials are undertaken once an aseptic process has been qualified and are designed to provide assurance that the process of filling products aseptically is done with a minimal likelihood of contamination. Media trials use a microbiological growth medium in place of product and subject the aseptic process to ‘worst case’ conditions, including practising personnel interventions. Filled vials are then incubated and later inspected for microbial growth. However, there are many variables to consider when establishing media trials. The chapter outlines the requirements for a media trial policy, explores acceptance criteria, outlines the steps involved in the media trial process, and concludes by outlining the important considerations for a failure investigation." @default.
- W67234054 created "2016-06-24" @default.
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- W67234054 date "2013-01-01" @default.
- W67234054 modified "2023-09-26" @default.
- W67234054 title "Media simulation trials" @default.
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- W67234054 doi "https://doi.org/10.1533/9781908818638.227" @default.
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