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FDA warns submissions sometimes measure component bioburden after sterilization rather than before
Summary
Chen said reviewers saw bioburden testing performed after filtration or sterilization, rather than pre‑sterilization testing that accurately reflects incoming microbial load; excessive acceptance limits also lacked justification.
Chen told attendees that a common error is performing bioburden testing after filtration or other sterilizing steps, which can understate the pre‑sterilization microbial load and mischaracterize process risk. She said pre‑sterilization bioburden testing of all phases is needed to depict overall bioburden accurately.
She also noted that when manufacturers propose high bioburden acceptance limits they must provide a scientific rationale supporting those limits; otherwise reviewers commonly issue information requests asking for justification.
