What are the reasons to failure of bioburden in injectables?
Thanks in advance
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Your question is generic. There could be N number of reasons for failure to bioburden in injectables, which could be, but not limited to,
- Raw materials
- Primary packaging materials
- Poor controls on clean rooms (sterile area)
-Inadequate environmental controls - Inadequate cleaning of equipment
-Input water or WFI quality (microbiological aspects)
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