Steam Sterilisation - Liquid Filters dh Intermediate Level Module 21A dh domnick hunter ltd. PROCESS DIVISION Objectives m Represent a typical LIQUID filter Steam In Place (SIP) procedure m Highlight potential problems and offer solutions dh dh domnick hunter ltd. PROCESS DIVISION Some Questions m Why Steam? To STERILISE the filter and probably downstream pipework dh m Minimum Requirements? Time = 20 mins Temperature = 1210C Pressure = 1.0 bar g dh domnick hunter ltd. PROCESS DIVISION CAUTION !! m 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 dh m Filter cartridges with a polypropylene core are more susceptible to damage at high temperature m To prevent cartridge filter damage during steaming avoid excess differential pressure at high temperature dh domnick hunter ltd. PROCESS DIVISION “How To” Guide m These guides give step by step instructions for the SIP of a typical LIQUID filter system m They can be used to check actual SIP methods dh m They should be used as the basis for writing customer-specific SIP procedures dh domnick hunter ltd. PROCESS DIVISION LIQUID FILTER SIP dh PHOTO OF BLOCKED/DAMAGED PALL THE PROBLEM ! dh domnick hunter ltd. PROCESS DIVISION Liquid filters - The Ideal Set-up P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Remember m It is very unlikely the existing system will exactly match the “ideal” layout m Use the principles and procedures from this training to evaluate or constructively evaluate an existing system dh m Practically adapt the typical system to meet the system requirements dh domnick hunter ltd. PROCESS DIVISION Note m Liquid filters should be steamed in the FORWARD direction only m Details of maximum steam temperatures and steam life for specific filters are given in the relevant data sheets dh dh domnick hunter ltd. PROCESS DIVISION Valve Sequence for Product Liquid Flow P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Drain the Product This is best achieved using a compressed air chase P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Drain the Product. This is best achieved using a compressed air chase Isolate the filter system for Steam In Place (SIP) P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Valve positions Pre SIP P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Open valves V 4, V 6 and V7 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Open valves V 4, V 6 and V7 = Pipework HOT P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION When the steam trap (ST 2) below V 5 closes, slowly open V 5 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION When the steam trap below V 5 closes, slowly open V 5 Note the steam flow across the filter P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION 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 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION When LIVE steam flows from valve V 4, slowly close V 4 This will direct the steam flow through the filter P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION 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 V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION 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 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION 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 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Sterilisation = 1210C for 20mins.Reduced time and or temperature would NOT guarantee sterility Sensor T 1 must maintain 1210C for the 20 mins P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION 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) P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION On completion of the steam sterilisation cycle, close valves V 2, V 5 and V 7 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION On completion of the steam sterilisation cycle, close valves V 2, V 5 and V 7 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION On completion of the steam sterilisation cycle, close valves V 2, V 5 and V 7 Slowly open valve V 4 STEAM P1 V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION On completion of the steam sterilisation cycle, close valves V 2, V 5 and V 7. Slowly open valve V 4 STEAM P1 V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Slowly open valve V 4 Allow the steam to exit the system until pressure gauges P1 and P2 display 0 bar g STEAM P1 V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION 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) P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Close valve V 4 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Close valve V 4 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Close valve V 4 Allow the filter temperature to fall to the normal operating temperature P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Close valve V 4 Allow the filter temperature to drop to the normal operating temperature P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION 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 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced Close valve V 6 STEAM P1 V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced . Close valve V 6 STEAM P1 V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced Close valve V 6 STEAM P1 V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION For PROCESS sterilisation Ensure valve V 2 is closed and V 3 and V 7 are open P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION 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 V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Open valve V 8 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Open valve V 8 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Open valve V 8 Allow the temperature to increase to the sterilisation minimum P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Allow the temperature to increase to the sterilisation minimum. Hold the minimum temperature for the minimum time P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Hold the minimum temperature for the minimum time Close valves V 3, V 7 and V 8 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Hold the minimum temperature for the minimum time Close valves V 3, V 7 and V 8 P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Close valves V 3, V 7 and V 8 Allow the process to cool P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Close valves V 3, V 7 and V 8 Allow the process to cool P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Valve Sequence for Product Liquid Flow P1 STEAM V4 V8 PRODUCT LIQUID V1 STEAM ST 1 T1 P2 V2 dh V6 V5 ST 2 V3 V7 ST 3 PROCESS dh domnick hunter ltd. PROCESS DIVISION Liquid Filter SIP - Check List m Ensure the system is fully drained prior to starting the SIP m Flow steam across the filter to an open vent or drain before attempting to flow steam through the filter m Monitor the differential pressure during SIP m Do not generate high steam flow through the filter by steaming to an ‘open end’ dh dh domnick hunter ltd. PROCESS DIVISION Liquid Filter SIP - Check List m Do not generate high steam flow through the filter by steaming high volume downstream systems through the filter dh m Vent the steam slowly to avoid pressure surges m Avoid the formation of a vacuum during cooling post SIP dh domnick hunter ltd. PROCESS DIVISION Steam Sterilisation - Liquid Filters dh Intermediate Level Module 21A dh domnick hunter ltd. PROCESS DIVISION
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