d h d h domnick hunter ltd. process division dh intermediate level module 21a steam sterilisation -...

dhdhdomnick hunter ltd.domnick hunter ltd. PROCESS DIVISIONPROCESS DIVISION

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Intermediate LevelIntermediate Level

Module 21AModule 21A

Steam Sterilisation - Liquid FiltersSteam Sterilisation - Liquid Filters


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ObjectivesObjectives

Represent a typical LIQUID filter Steam In Represent a typical LIQUID filter Steam In Place (SIP) procedurePlace (SIP) procedure

Highlight potential problems and offer Highlight potential problems and offer solutionssolutions


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Some QuestionsSome Questions

Why Steam?Why Steam?To STERILISE the filter and probably To STERILISE the filter and probably downstream pipeworkdownstream pipework

Minimum Requirements?Minimum Requirements?Time = 20 minsTime = 20 minsTemperature = 121Temperature = 12100CCPressure = 1.0 bar gPressure = 1.0 bar g


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CAUTION !!CAUTION !!

All cartridge filters will have a finite steam life under All cartridge filters will have a finite steam life under optimum steaming conditions. Poor steaming optimum steaming conditions. Poor steaming conditions WILL reduce the steam life of a cartridge conditions WILL reduce the steam life of a cartridge filterfilter

Filter cartridges with a polypropylene core are more Filter cartridges with a polypropylene core are more susceptible to damage at high temperaturesusceptible to damage at high temperature

To prevent cartridge filter damage during steaming To prevent cartridge filter damage during steaming avoid excess differential pressure at high temperatureavoid excess differential pressure at high temperature


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““How To” GuideHow To” Guide

These guides give step by step instructions for These guides give step by step instructions for the SIP of a typical LIQUID filter systemthe SIP of a typical LIQUID filter system

They can be used to check actual SIP methodsThey can be used to check actual SIP methods

They should be used as the basis for writing They should be used as the basis for writing customer-specific SIP procedurescustomer-specific SIP procedures


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THE THE PROBLEM ! PROBLEM !

PHOTO OFPHOTO OF BLOCKED/DAMAGEDBLOCKED/DAMAGED PALLPALL

LIQUID FILTER LIQUID FILTER SIPSIP


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Liquid filters - The Ideal Set-upLiquid filters - The Ideal Set-up


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RememberRemember

It is very unlikely the existing system will exactly It is very unlikely the existing system will exactly match the “ideal” layout match the “ideal” layout

Use the principles and procedures from this Use the principles and procedures from this training to evaluate or constructively evaluate an training to evaluate or constructively evaluate an existing systemexisting system

Practically adapt the typical system to meet the Practically adapt the typical system to meet the system requirementssystem requirements


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Note Note

Liquid filters should be steamed in the Liquid filters should be steamed in the FORWARD direction onlyFORWARD direction only

Details of maximum steam temperatures and Details of maximum steam temperatures and steam life for specific filters are given in the steam life for specific filters are given in the relevant data sheetsrelevant data sheets


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Valve Sequence for Product Liquid Flow


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 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


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Drain the Product. This is best achieved using a compressedair chaseIsolate the filter system for Steam In Place (SIP)


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Valve positions Pre SIP


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Open valves V 4, V 6 and V7


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Open valves V 4, V 6 and V7

= Pipework HOT


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 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


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

When the steam trap below V 5 closes, slowly open V 5Note the steam flow across the filter


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

When the steam trap below V 5 closes, slowly open V 5Note the steam flow across the filterWhen LIVE steam flows from valve V 4, slowly close V 4


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

When LIVE steam flows from valve V 4, slowly close V 4This will direct the steam flow through the filter


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

When LIVE steam flows from valve V 4, slowly close V 4This will direct the steam flow through the filterThe differential pressure (dp) must not exceed 0.2-0.34 bar g (3-5psi)

dp = P1- P2


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 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


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 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 = 1210C for 20mins -Reduced time and or temperature would NOT guarantee sterility


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Sterilisation = 1210C for 20mins.Reduced time and or temperature would NOT guarantee sterilitySensor T 1 must maintain 1210C for the 20 mins


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Sensor T 1 must maintain 1210C for the 20 minsThe differential pressure (dp) must not exceed 0.2-0.34 bar g (3-5psi)


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

On completion of the steam sterilisation cycle, closevalves V 2, V 5 and V 7


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

On completion of the steam sterilisation cycle, closevalves V 2, V 5 and V 7Slowly open valve V 4


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

On completion of the steam sterilisation cycle, closevalves V 2, V 5 and V 7.Slowly open valve V 4


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Slowly open valve V 4Allow the steam to exit the system until pressure gauges P1 andP2 display 0 bar g


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Allow the steam to exit the system until pressure gauges P1 andP2 display 0 bar gDuring this process the differential pressure (dp) must not exceed 0.2-0.34 bar g (3-5psi)


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Close valve V 4


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Close valve V 4Allow the filter temperature to fall to the normal operating temperature


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Close valve V 4Allow the filter temperature to drop to the normal operating temperature


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Allow the filter temperature to drop to the normal operating temperatureDuring the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 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


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 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


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 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


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

For PROCESS sterilisationEnsure valve V 2 is closed and V 3 and V 7 are open


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

For PROCESS sterilisationEnsure 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


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Open valve V 8


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Open valve V 8Allow the temperature to increase to the sterilisation minimum


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 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


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Hold the minimum temperature for the minimum timeClose valves V 3, V 7 and V 8


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Close valves V 3, V 7 and V 8Allow the process to cool


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STEAM

PRODUCTLIQUID

PROCESS

STEAM

V 1 V 2 V 3

V 4

V 5V 6

V 7

V 8

ST 1 ST 2 ST 3

P1

P2T1

Valve Sequence for Product Liquid Flow


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Liquid Filter SIP - Check ListLiquid Filter SIP - Check List

Ensure the system is fully drained prior to Ensure the system is fully drained prior to starting the SIPstarting the SIP

Flow steam across the filter to an open vent or Flow steam across the filter to an open vent or drain before attempting to flow steam through drain before attempting to flow steam through the filterthe filter

Monitor the differential pressure during SIPMonitor the differential pressure during SIP Do not generate high steam flow through the Do not generate high steam flow through the

filter by steaming to an ‘open end’filter by steaming to an ‘open end’


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Do not generate high steam flow through the Do not generate high steam flow through the filter by steaming high volume downstream filter by steaming high volume downstream systems through the filtersystems through the filter

Vent the steam slowly to avoid pressure surgesVent the steam slowly to avoid pressure surges

Avoid the formation of a vacuum during cooling Avoid the formation of a vacuum during cooling post SIPpost SIP

Liquid Filter SIP - Check ListLiquid Filter SIP - Check List


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Intermediate LevelIntermediate Level

Module 21AModule 21A

Steam Sterilisation - Liquid FiltersSteam Sterilisation - Liquid Filters

d h d h domnick hunter ltd. process division dh intermediate level module 21a steam sterilisation -...

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