1. d h d h domnick hunter ltd. PROCESS DIVISION dh Intermediate Level Module 21A Steam Sterilisation - Liquid Filters

2. d h d h domnick hunter ltd. PROCESS DIVISION dhObjectives mRepresent a typical LIQUID filter Steam In Place (SIP) procedure mHighlight potential problems and offer solutions

3. d h d h domnick hunter ltd. PROCESS DIVISION dh Some Questions mWhy Steam? To STERILISE the filter and probably downstream pipework mMinimum Requirements? Time = 20 mins Temperature = 121 0 C Pressure = 1.0 bar g

4. d h d h domnick hunter ltd. PROCESS DIVISION dh CAUTION !! mAll cartridge filters will have a finite steam life under optimum steaming conditions. Poor steaming conditions WILL reduce the steam life of a cartridge filter mFilter cartridges with a polypropylene core are more susceptible to damage at high temperature mTo prevent cartridge filter damage during steaming avoid excess differential pressure at high temperature

5. d h d h domnick hunter ltd. PROCESS DIVISION dh How To Guide mThese guides give step by step instructions for the SIP of a typical LIQUID filter system mThey can be used to check actual SIP methods mThey should be used as the basis for writing customer-specific SIP procedures

6. d h d h domnick hunter ltd. PROCESS DIVISION dh THE PROBLEM ! THE PROBLEM ! PHOTO OF BLOCKED/DAMAGED BLOCKED/DAMAGED PALL PALL LIQUID FILTER SIP

7. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Liquid filters - The Ideal Set-up

8. d h d h domnick hunter ltd. PROCESS DIVISION dhRemember mIt is very unlikely the existing system will exactly match the ideal layout mUse the principles and procedures from this training to evaluate or constructively evaluate an existing system mPractically adapt the typical system to meet the system requirements

9. d h d h domnick hunter ltd. PROCESS DIVISION dhNote mLiquid filters should be steamed in the FORWARD direction only mDetails of maximum steam temperatures and steam life for specific filters are given in the relevant data sheets

10. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Valve Sequence for Product Liquid Flow

11. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Drain the Product - This is best achieved using a compressed air chase

12. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Drain the Product. This is best achieved using a compressed air chase Isolate the filter system for Steam In Place (SIP)

13. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Valve positions Pre SIP

14. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Open valves V 4, V 6 and V7

15. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Open valves V 4, V 6 and V7 = Pipework HOT

16. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 When the steam trap (ST 2) below V 5 closes, slowly open V 5

17. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 When the steam trap below V 5 closes, slowly open V 5 Note the steam flow across the filter

18. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 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

19. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 When LIVE steam flows from valve V 4, slowly close V 4 This will direct the steam flow through the filter

20. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 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

21. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 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

22. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 When the Steam Trap (ST 3) below valve V7 closes the system pressure will begin to rise. Sterilisation = 121 0 C for 20mins - Reduced time and or temperature would NOT guarantee sterility

23. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Sterilisation = 121 0 C for 20mins.Reduced time and or temperature would NOT guarantee sterility Sensor T 1 must maintain 121 0 C for the 20 mins

24. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Sensor T 1 must maintain 121 0 C for the 20 mins The differential pressure (dp) must not exceed 0.2-0.34 bar g (3-5psi)

25. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 On completion of the steam sterilisation cycle, close valves V 2, V 5 and V 7

26. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 On completion of the steam sterilisation cycle, close valves V 2, V 5 and V 7

27. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 On completion of the steam sterilisation cycle, close valves V 2, V 5 and V 7 Slowly open valve V 4

28. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 On completion of the steam sterilisation cycle, close valves V 2, V 5 and V 7. Slowly open valve V 4

29. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Slowly open valve V 4 Allow the steam to exit the system until pressure gauges P1 and P2 display 0 bar g

30. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 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)

31. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Close valve V 4

32. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Close valve V 4

33. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Close valve V 4 Allow the filter temperature to fall to the normal operating temperature

34. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Close valve V 4 Allow the filter temperature to drop to the normal operating temperature

35. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 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

36. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced Close valve V 6

37. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced. Close valve V 6

38. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced Close valve V 6

39. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 For PROCESS sterilisation Ensure valve V 2 is closed and V 3 and V 7 are open

40. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 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

41. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Open valve V 8

42. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Open valve V 8

43. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Open valve V 8 Allow the temperature to increase to the sterilisation minimum

44. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Allow the temperature to increase to the sterilisation minimum. Hold the minimum temperature for the minimum time

45. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Hold the minimum temperature for the minimum time Close valves V 3, V 7 and V 8

46. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Hold the minimum temperature for the minimum time Close valves V 3, V 7 and V 8

47. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Close valves V 3, V 7 and V 8 Allow the process to cool

48. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Close valves V 3, V 7 and V 8 Allow the process to cool

49. d h d h domnick hunter ltd. PROCESS DIVISION dh STEAM PRODUCT LIQUID PROCESS STEAM V 1V 2V 3 V 4 V 5 V 6 V 7 V 8 ST 1 ST 2 ST 3 P1 P2T1 Valve Sequence for Product Liquid Flow

50. d h d h domnick hunter ltd. PROCESS DIVISION dh Liquid Filter SIP - Check List mEnsure the system is fully drained prior to starting the SIP mFlow steam across the filter to an open vent or drain before attempting to flow steam through the filter mMonitor the differential pressure during SIP mDo not generate high steam flow through the filter by steaming to an open end

51. d h d h domnick hunter ltd. PROCESS DIVISION dh mDo not generate high steam flow through the filter by steaming high volume downstream systems through the filter mVent the steam slowly to avoid pressure surges mAvoid the formation of a vacuum during cooling post SIP Liquid Filter SIP - Check List

52. d h d h domnick hunter ltd. PROCESS DIVISION dh Intermediate Level Module 21A Steam Sterilisation - Liquid Filters