Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-032.00 Effective date: mm/dd/yyyy
Approved by:
51.7.2.8.1 Media-Fill Runs Exceeding Action Levels and Corrective Actions
Investigation shall include all the steps defined in Section 51.7.2.7.1.
• A contaminated container should be examined carefully for any breach in the container
system.
• All positives (from integral containers) should be identiied till the species level.
• The identiication of contaminant should be compared to the database of the organisms
recently identified.
• The biochemical proile of the contaminant can be compared with that of microorganisms
obtained from the sterility tests and bio-burden and environmental monitoring programs,
in order to help identify the potential sources of the contaminant.
If the media fill contaminant is the same as the sterility test contaminant:
• Increase media ill units and routine illing environmental monitoring to identify the
source of contamination.
• Review environmental data obtained during line set up.
If the media fill contaminant is the same as the media fill environmental contaminant:
• Increase routine environmental monitoring to determine if the contamination potential
exists during routine filling operation.
If the media fill contaminant is the same as the routine environmental contaminant:
• Increase media ill environmental monitoring (in the same location) to conirm the con-
taminant source.
If the sterility tests contaminant is the same as the media fill environmental contaminant:
• Increase routine environmental monitoring (in the same location) and number of media ill
vial to conform.
If the sterility test contaminant is the same as the routine environmental contaminant:
• Sterility test voided.
• Investigate sterility test procedures and room sanitation/sterilization methods to eliminate
cause.
If the media fill environmental contaminant is the same as the routine environmental contaminant:
• Increases the number of media ill vials in media ill in order to determine the product risk
potential.
• Review monitoring technique for possible problem.
• Review personnel practices, gowning, sanitation, and sterilization.
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