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2. Initial Bioburden of Packaging Material

Microbiologic raw packaging material evaluation:

  • Before using packaging materials such as preforms, caps or bottles, the initial bioburden will be evaluated. This evaluation will be carried out on 10 units of the packaging material sampled in accordance with good laboratory practice.
  • Preforms or caps will be placed in sterile vials filled with a sterile recovery liquid based on pure sterile water containing 1 ‰ of Tween 80.
  • Inside of the bottles: fill 100 ml of the recovery agent in the bottle, and close it with a sterile cap. Complete bottles: cut the bottles in different parts under aseptic conditions in order to be able to place the pieces in a sterile container. Then proceed as with caps or preforms.
  • After shaking, the recovery liquid is filtered on a membrane that will be incubated on a Plate Count Agar during 5 days at 30°C.
  • After incubation the CFU’s will be counted.
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