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

Intermediate LevelIntermediate Level

Module 21AModule 21A

Steam Sterilisation - Liquid FiltersSteam Sterilisation - Liquid Filters

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

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

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

““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

THE THE PROBLEM ! PROBLEM !

PHOTO OFPHOTO OF BLOCKED/DAMAGEDBLOCKED/DAMAGED PALLPALL

LIQUID FILTER LIQUID FILTER SIPSIP

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

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

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

Valve Sequence for Product Liquid Flow

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

Drain the Product - This is best achieved using a compressed air chase

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

Valve positions Pre SIP

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

Open valves V 4, V 6 and V7

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

Open valves V 4, V 6 and V7

= Pipework HOT

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

When the steam trap (ST 2) below V 5 closes, slowly open V 5

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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)

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

Close valve V 4

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

Close valve V 4

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced Close valve V 6

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced .Close valve V 6

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

During the cooling period ensure a vacuum in excess of 0.34 bar g (5psi) is not produced Close valve V 6

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

Open valve V 8

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

Open valve V 8

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

Allow the temperature to increase to the sterilisation minimum.Hold the minimum temperature for the minimum time

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

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

PRODUCTLIQUID

PROCESS

V 1 V 2 V 3

V 5V 6

ST 1 ST 2 ST 3

Valve Sequence for Product Liquid Flow

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’

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

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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