530 likes | 854 Vues
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
E N D
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 • Minimum Requirements?Time = 20 mins Temperature = 1210CPressure = 1.0 bar g
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
“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
LIQUID FILTER SIP THE PROBLEM ! PHOTO OF BLOCKED/DAMAGED PALL
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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’