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STERILIZATION IN PLACE (SIP) SYSTEMS
Pharmaceutical Sterilization-in-Place (SIP) systems are designed to sterilize a collection of process equipment after a batch of product is completed. Equipment such as bioreactors, fermentors and the accompanying tubing must be cleaned and/or sterilized before a new production cycle .
The steam pressures seen are typically in the 20-30 psi range with corresponding temperatures ranging from 121ºC to 135ºC. The relationship between pressure and temperature is a given, however sterilization times will range depending on the temperature and the nature of the item being sterilized. In general, the lower the temperature, the longer it takes to sterilize. The sterilization time/temperature relationship in a typical SIP process will occur at about 121ºC for 30-40 minutes. For systems with hard to reach components, times can increase.
Steam quality is also an important consideration. Typically, a dedicated clean-steam generator is used to provide the necessary volume, temperature and pressure of steam needed to sterilize each system. To ensure that each component and all areas of the piping reach the sterilization temperature for the requisite time, temperature sensors are placed in critical areas as well as in hard-to-reach locations to ensure that complete sterilization occurs. During this entire process, modulating valves are utilized to maintain the
required clean steam pressure, temperature and flow levels.
During the SIP process, condensate is generated from steam which must be quickly removed. Proper placement of clean steam traps will ensure timely and adequate removal of the condensate, which, in turn, will help to maintain the high temperatures needed for the sterilization cycle.
Besides the critical function of the clean steam generator, three components in particular are crucial to maintaining adequate wet temperature in SIP networks: sanitary control valves, sanitary pressure regulators and sanitary steam traps.
SYSTEM DETAILS
The SIP has a microprocessor control system for temperature monitoring throughout the sterilisation cycle with validation printout facility
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