BY PACKAGING


Sterile Product: Quality Control

  1. Product and pack compatibility – the components must be washed and sterilized through a validated procedure. The vials must be filled with the sterile product under sterile conditions and terminally sterilized if this is a part of the intended if this is a part of the intended product operation. Components performance should be monitored during the compatibility trials to ensure that deterioration has not occurred.
  2. Seal integrity – the seals of each vial should be examined before the experiment to ensure that there are no defectives, and then each vial should be inserted into a tray containing the challenge bacteria. The samples should be cycled through temperature and pressure changes expected on the market for several weeks. Careful cleaning of the vials and examination of contents for sterility will determine the seal quality.