Bioburden analysis

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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