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Steam Sterilisation - Sterile Air Filters
  • Intermediate Level
  • Module 21B
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Objectives
  • Represent a typical GAS filter Steam In Place (SIP) procedure
  • Highlight potential problems and offer solutions
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Some Questions
  • Why Steam?
    To STERILISE the filter and downstream pipework
  • Minimum Requirements?
    Time = 20 mins
    Temperature = 1210C
    Pressure = 1.0 bar g
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CAUTION !!
  • All cartridge filters will have a finite steam life under optimum steaming conditions - poor steaming conditions WILL reduce the steam life of a cartridge filter
  • Filter cartridges with a polypropylene core are more susceptible to damage at high temperature
  • To prevent cartridge filter damage during steaming avoid excess differential pressure at high temperature
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“How To” Guide
  • These guides give step by step instructions for the SIP of a typical  GAS  filter system
  • They can be used to check actual SIP methods
  • They should be used as the basis for writing customer-specific SIP procedures
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Remember
  • It is very unlikely the existing system will exactly match the “ideal” layout
  • Use the principles and procedures from this training to evaluate or constructively evaluate an existing system
  • Practically adapt the typical system to meet the system requirements
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Note
  • Gas filters should be steamed in the FORWARD direction when possible
  • However in some applications it is necessary to reverse steam filters
  • Details of maximum steam temperatures and steam life for specific filters are given on the relevant data sheets
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Alternative Method to flash drying
  • Instead of flash drying the filters
  • compressed air can be used


  • Compressed air should always be used for systems larger than single
    10” / 250 mm filters
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Both Methods
  • Resume normal air / gas
  • sterilisation or conduct
  • an IN-LINE integrity test
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For Both Methods
  • Resume normal air / gas
  • sterilisation or conduct
  • an IN-LINE integrity test
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Gas Filter SIP
The 3 Golden Rules
  • CONDENSATE
  • CONDENSATE
  • CONDENSATE
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Gas Filter SIP - Check List
  • PTFE filters are strongly hydrophobic so condensate will generate high differential pressure at high temperature
  • Flow steam across the filter to an open vent or drain before attempting to flow steam through the filter
  • Monitor the differential pressure during SIP
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Gas Filter SIP - Check List
  • Do not generate high steam flow through the filter by steaming to an open end
  • Do not generate high steam flow through the filter by steaming high volume downstream systems through the filter
  • Slope pipework to and from the filter housing so condensate will naturally run away from the filter
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Steam Sterilisation - Sterile Air Filters
  • Intermediate Level
  • Module 21B