What is Sterilization in Place (SIP)

 Most pharmaceutical GMP systems available today incorporate some form of sterilization using steam. In situ sterilization of equipment using a medium called Pure Saturated Steam. The installation comprises of one or more pieces of processing equipment

Example • Fermentor or a centrifugal separator to handle harvests, connected by rigid stainless steel or flexible Teflon-lined piping

Why is there a need for sterilization?

  • To increase the level of sterility assurance associated with those products made by aseptic processing.
  • The size and configuration of large number of process equipment utilized in the production of Biological/parenteral restricts them to be placed inside an autoclave for sterilization.
  • To assure a higher degree of sterility assurance for these items, they should be sterilized in situ rather than sanitized.
  • SIP is required as a result of desire for enhanced sterility assurance for aseptically produced materials.
  • Steam SIP is in daily use in the Biological & parenteral industry.

What makes SIP a critical process?

  • Steam-in-place sterilization enables the entire processing system to be sterilized as a single entity thereby reducing the need for aseptic connections.
  • Criticality of system design to achieve sterility with SIP is considered more closely than the steam sterilizer.
  • SIP employs the same moist heat mechanism as steam sterilization in autoclaves.

SIP Fundamentals

  • SIP differs only slightly from steam sterilization in autoclaves.
  • To achieve effective SIP, the elements necessary for process effectiveness inherent in the autoclave design and operation must be provided in the SIP system.

What is a saturated pure steam?

  • Saturated steam is a steam-water mixture in which the vapour phase (steam) is in equilibrium with the liquid phase (water or condensate).
  • The addition of heat to saturated steam can result in its de-saturation (or superheating).
  • The loss of heat from saturated steam will result in its condensation.

SIP Design Considerations

  • Complete displacement and elimination of entrapped air.
  • Constant bleeds of steam at all low points to eliminate condensate build-up Heating large masses of stainless steel from ambient temperature to 121°C results in the creation of large quantities of condensate.
  • Strict adherence to the sterilization procedures.
  • Proper maintenance of the sterility after the process.

  • SIP system design concepts is achieved through a review of the equipment elements that make up that system.
• The Components of an SIP system:
   Pressure Vessels
   Piping system
   Filters

  • The system must be designed in a way that condensate can be readily removed.
  • To achieve this objective, system is sterilized in multiple patterns, in which each pattern sterilizes a portion of the larger system.
  • Some portions of the system must be sterilized more than once to assure that all portions of the system are fully covered.

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