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3. Validation Format

  • Only one format is chosen for microbiological validation: Usually this is the one with the lowest treatment time available i.e., the smallest bottle because it runs at highest speed and represents the most critical condition.
  • In agreement with both parties, also the main contractual format or the one with the most difficult shape or geometry may be selected as the validation format.
  • If the microbiological performance has been proven with this format all other formats perform equal or better. In this case, no further microbiological tests with other formats are required.
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