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.
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.
