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Steam Sterilisation - Liquid Filters

Steam Sterilisation - Liquid Filters. Intermediate Level Module 21A. Objectives. Represent a typical LIQUID filter Steam In Place (SIP) procedure Highlight potential problems and offer solutions. Some Questions. Why Steam? To STERILISE the filter and probably downstream pipework

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Steam Sterilisation - Liquid Filters

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  1. Steam Sterilisation - Liquid Filters Intermediate Level Module 21A

  2. Objectives • Represent a typical LIQUID filter Steam In Place (SIP) procedure • Highlight potential problems and offer solutions

  3. Some Questions • Why Steam?To STERILISE the filter and probably downstream pipework • Minimum Requirements?Time = 20 mins Temperature = 1210CPressure = 1.0 bar g

  4. 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

  5. “How To” Guide • These guides give step by step instructions for the SIP of a typical LIQUID filter system • They can be used to check actual SIP methods • They should be used as the basis for writing customer-specific SIP procedures

  6. LIQUID FILTER SIP THE PROBLEM ! PHOTO OF BLOCKED/DAMAGED PALL

  7. Liquid filters - The Ideal Set-up STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  8. 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

  9. Note • Liquid filters should be steamed in the FORWARD direction only • Details of maximum steam temperatures and steam life for specific filters are given in the relevant data sheets

  10. Valve Sequence for Product Liquid Flow STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  11. Drain the Product - This is best achieved using a compressed air chase STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  12. Drain the Product. This is best achieved using a compressed air chase Isolate the filter system for Steam In Place (SIP) STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  13. Valve positions Pre SIP STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  14. Open valves V 4, V 6 and V7 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  15. Open valves V 4, V 6 and V7 = Pipework HOT STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  16. When the steam trap (ST 2) below V 5 closes, slowly open V 5 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  17. When the steam trap below V 5 closes, slowly open V 5 Note the steam flow across the filter STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  18. When the steam trap below V 5 closes, slowly open V 5 Note the steam flow across the filter When LIVE steam flows from valve V 4, slowly close V 4 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  19. When LIVE steam flows from valve V 4, slowly close V 4 This will direct the steam flow through the filter STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  20. When LIVE steam flows from valve V 4, slowly close V 4 This will direct the steam flow through the filter The differential pressure (dp) must not exceed 0.2-0.34 bar g (3-5psi) dp = P1- P2 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  21. The differential pressure (dp) must not exceed 0.2-0.34 bar g (3-5psi) When the Steam Trap (ST 3) below valve V7 closes the system pressure will begin to rise STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  22. When the Steam Trap (ST 3) below valve V7 closes the system pressure will begin to rise. Sterilisation = 1210C for 20mins -Reduced time and or temperature would NOT guarantee sterility STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  23. Sterilisation = 1210C for 20mins.Reduced time and or temperature would NOT guarantee sterility Sensor T 1 must maintain 1210C for the 20 mins STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  24. Sensor T 1 must maintain 1210C for the 20 mins The differential pressure (dp) must not exceed 0.2-0.34 bar g (3-5psi) STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  25. On completion of the steam sterilisation cycle, close valves V 2, V 5 and V 7 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  26. On completion of the steam sterilisation cycle, close valves V 2, V 5 and V 7 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  27. On completion of the steam sterilisation cycle, close valves V 2, V 5 and V 7 Slowly open valve V 4 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  28. On completion of the steam sterilisation cycle, close valves V 2, V 5 and V 7. Slowly open valve V 4 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  29. Slowly open valve V 4 Allow the steam to exit the system until pressure gauges P1 and P2 display 0 bar g STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  30. Allow the steam to exit the system until pressure gauges P1 and P2 display 0 bar g During this process the differential pressure (dp) must not exceed 0.2-0.34 bar g (3-5psi) STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  31. Close valve V 4 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  32. Close valve V 4 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  33. Close valve V 4 Allow the filter temperature to fall to the normal operating temperature STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  34. Close valve V 4 Allow the filter temperature to drop to the normal operating temperature STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  35. Allow the filter temperature to drop to the normal operating temperature During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  36. During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced Close valve V 6 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  37. During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced . Close valve V 6 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  38. During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced Close valve V 6 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  39. For PROCESS sterilisation Ensure valve V 2 is closed and V 3 and V 7 are open STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  40. For PROCESS sterilisation Ensure valve V 2 is closed and V 3 and V 7 are open. This PREVENTS the filter and the process being steam sterilised at the same time STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  41. Open valve V 8 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  42. Open valve V 8 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  43. Open valve V 8 Allow the temperature to increase to the sterilisation minimum STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  44. Allow the temperature to increase to the sterilisation minimum. Hold the minimum temperature for the minimum time STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  45. Hold the minimum temperature for the minimum time Close valves V 3, V 7 and V 8 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  46. Hold the minimum temperature for the minimum time Close valves V 3, V 7 and V 8 STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  47. Close valves V 3, V 7 and V 8 Allow the process to cool STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  48. Close valves V 3, V 7 and V 8 Allow the process to cool STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  49. Valve Sequence for Product Liquid Flow STEAM P1 V 4 V 8 T1 P2 V 1 V 2 V 3 PRODUCT LIQUID V 5 V 7 V 6 STEAM ST 2 ST 1 ST 3 PROCESS

  50. Liquid Filter SIP - Check List • Ensure the system is fully drained prior to starting the SIP • 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 • Do not generate high steam flow through the filter by steaming to an ‘open end’

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