Biomedical Engineering Reference
In-Depth Information
If the media fill environmental contaminant is the same as sterility test contaminant and if the rou-
tine environmental contaminant is the same as the sterility test contaminant:
• Check environmental monitoring methods and techniques closely for problems.
• Review personnel practices, gowning, sanitation, and sterilization.
• If the contaminated unit
is less
than the action limit: Cease qualification media fill, inves-
tigate the cause, repeat initial performance qualification (three media fills).
51.8 reason for revision
First time issued for the ABC Pharmaceutical Company.
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