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Steam In Place
technical information • product support • new developments
domnick hunter bring extensive experience through our scientists, engineers and sales
representatives to the process of offering specific filtration systems to meet the needs of your
production process. Support services are available covering a wide range of activities including
scale up advice from laboratory through pilot scale to production systems, validation support,
design and manufacturing of custom housings and filtration products and on-site technical
support.
Committed to quality
Quality is of paramount importance to domnick hunter. As such domnick hunter has been
certified to ISO 9001 since 1987, providing a quality management system that covers the entire
organisation from R&D, production, warehousing, materials management and customer support.
In addition, our manufacturing facilities operate to the principles of cGMP.
This commitment is underlined by our registration to ISO 14001 during 2001 and our move to
ISO9001:2000.
To certify that domnick hunter products meet the required regulatory and quality standards of
the industries we supply, all filters are supplied with a certificate of conformance. These
certificates are linked to validation guides for both pre-filter and sterilising grade membrane filter
cartridges that define methodologies and data appropriate to each filter type. This information
typically includes:
• technical specifications
• biological safety testing including Current USP<88> Class VI - 121°C Plastics
• extractable testing including 21 CFR 211.72 and 210.3(b), (6) for fibre releasing filters
• effluent quality including TOC, bacterial endotoxins, water conductivity and particle release
• chemical compatibility information
• thermal stability
• correlation of a non destructive integrity test to a defined bacterial challenge
Where appropriate these data are included in the domnick hunter Drug Master File – DMF 7564
at the U.S. Food and Drug Administration (FDA).
domnick hunter has extensive laboratory facilities and trained personnel capable of providing a
range of validation support services to support manufacturers meet their requirements for
process validation relating to the use of filtration products.
Section
1: Introduction
2: General Principles
3: Practical SIP
4: Steam-in-Place Procedures
The ability of a cartridge filter to be sterilised in situ within its housing represents a significant
operational advantage for many filter users. Steam in place (SIP) avoids the need to use
chemical sanitising agents or to compromise the integrity of the filtration installation, minimises
operator hands on time and plant downtime and can be easily incorporated into automated
production facilities. To achieve reproducible sterilisation conditions (typically a minimum of
121°C for 30 minutes) and to avoid damage to the installed filter cartridge(s), it is important to
carefully design and monitor SIP procedures. Factors including steam temperature and quality,
condensate removal, differential pressure and cooling cycles need to be considered.
The purpose of this document is to detail the recommended methods of SIP for domnick hunter
cartridge filters, to avoid accidental damage to cartridges and maximise the steam life of installed
filters.
Condensate:
Optimum steam sterilisation of filter cartridges can be achieved using dry steam. Wet steam
(steam containing high level of condensed water) will not flow easily through the filter. This
resistance to flow will generate increased differential pressure across the filter at elevated
temperatures, conditions which cause the maximum stress to the filter cartridge. Condensate
should therefore be removed by a manual valve or an automated steam trap, located as close
to the filter as possible, to avoid condensate contact with the filter.
Particulate:
Many steam lines suffer from corrosion over a prolonged time period. This can introduce
particulate into the steam which will be retained by the filter being steamed. This will accelerate
the rate of filter blockage or worse, cause damage to the filter. Pipe corrosion can result in metal
fragments which when carried to the filter could puncture the support materials and membrane.
To control particulate in steam lines, so protecting the filter cartridge to be steamed,
domnick hunter supply a range of in line steam filters. Details of the domnick hunter stainless
steel steam filter range are available from your local domnick hunter office.
Chemical additives:
Chemicals are often added to the feed water in steam generators. These chemicals will form part
of the steam and so will contact the filter cartridge being steam sterilised. Most standard steam
generator additives do not pose any problem for the steam filter or filter cartridge being sterilised.
If you have any doubt regarding steam generator additives please contact Technical Support
Group, Process Filtration, domnick hunter.
There is a direct relationship between steam temperature and pressure. Increasing the steam
pressure facilitates an increase in the temperature of the pressurised steam. The following graph
illustrates this relationship.
Temperature Pressure Relationship
135
130
125
Temperature (°C)
120
115
110
105
100
0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 2.0
Pressure bar (Gauge)
1 Thermodynamic and Transport Properties of Fluids. SI units by G.F.C Rogers and Y.R Mayhew.
Oxford Basil Blackwell 1981 (0631 128913).
Filters should generally be supplied with steam from the upstream side (normal flow direction).
Steam flow from the downstream side should be avoided, but may be appropriate in some
circumstances for air filters. Reverse flow should not be used for liquid filters. Steam should not
be applied to both sides of the filter at the same time as this can potentially trap a pocket of dry
air between the steam supplies, reducing the heat transfer to the filter and therefore negatively
impacting the steam sterilisation conditions.
During normal steam sterilisation cycles, as steam is applied to the filter housing, air is purged
from the system such that saturated steam contacts and heats all the filter and housing surfaces.
As the steam heats and subsequently flows through the cartridge filter, there will be an inherent
resistance to that flow. The amount of resistance to the steam flow is measured as a drop in
pressure across the filter and is called the differential pressure.
Upstream Downstream
Differential Pressure = -
Steam Pressure Steam Pressure
When a cartridge filter is heated to 121°C or higher, this procedure places significant stress on
the unit. During the SIP process the physical properties of the cartridge filter components are
weakened at elevated temperature (e.g. increased plasticity of polymers). It is therefore
important that at temperatures of 121°C or higher, the differential pressure across the filter
cartridge should not exceed 0.3 barg. Differential pressure above this level may lead to filter
damage.
Consideration of process parameters to limit differential pressure during SIP is therefore critical
and includes:
The following considerations should be given to the installation of filter housings that will be
steam sterilised:
- The installation should ensure that condensate cannot accumulate in the housing. Housings
or upstream pipework should therefore be fitted with condensate drains.
Condensate removal is particularly important when steam sterilising hydrophobic gas filter
cartridges. domnick hunter manufacture a range of gas filter housings which incorporate a
plenum chamber. This upstream chamber collects steam condensate and inhibits contact with
the hydrophobic filter cartridge. The plenum chamber is one of the specific design features
that differentiate domnick hunter gas filter housings from liquid filter housings.
- The cartridge and housing should be in a normal orientation (vertical, with the open end of the
cartridge pointing downwards).
- The pipework downstream of the filter housing should be as short as possible. domnick
hunter recommend a maximum of 100cm. Tanks downstream of the filter should always be
steam sterilised separately.
- The pipework should be positioned at a slight incline allowing gravity to collect the steam
condensate at a steam drain or steam trap.
- Length of pipeline, relative to steam flow rate, may result in pressure loss. The length of steam
supply pipework should be kept to a minimum.
Whilst saturated steam behaves as a gas and so flows easily through filters, contact with any
cool surface (e.g. stainless steel housings or pipework) will lead to the generation of condensate
as the steam cools. In some systems, very large volumes of condensate may be generated due
to this process (e.g. multiple cartridge housings, extended pipework run etc). In any case, the
removal of condensate from any SIP system is important for a number of reasons:
1. Condensate can ‘blind’ both hydrophilic and hydrophobic membranes to steam flow,
potentially leading to filter damage due to the development of high differential pressures
across the membrane at high temperature.
3. Hydraulic shock may occur due to ‘slugs’ of steam being forced through the line.
In designing process systems, the effects of condensate generation can also be minimised by
ensuring that housings are not located at the bottom of long pipe runs, or that these are steam
sterilised separately from the filter.
As discussed above, the removal of condensate from systems is important to ensure efficient
steam sterilisation. A thermodynamic steam trap or condensate trap is a mechanical valve to
remove condensate. They are located at points upstream and downstream of the filter where
condensate would collect (i.e. low points in the system). These steam traps work on the
principle that as condensate collects the temperature at the trap falls below that required for
effective steam sterilisation (121°C). At this point the valve opens, drains the condensate and
draws in live steam from the steam supply. Steam traps can be replaced by a manual valve that
is left slightly open, but requires control by a skilled operator to ensure effective condensate
removal without draining excessive steam.
Steam sterilisation under carefully controlled conditions is an accepted process operation for
filter cartridges. However, this does represent an aggressive process condition and can lead to
filter damage should steam sterilisation conditions deviate from controlled norms. It is therefore
recommended that filter cartridges are integrity-tested in-situ after steam sterilisation and before
use. For advice on in-situ integrity testing of filter cartridges please refer to domnick hunter.
domnick hunter cartridge filters undergo extensive steam sterilisation verification trials during
their development. During these trials a number of filter cartridges from several production lots
are steam sterilised at 121-142°C depending on the filter type. After each 30-minute steam
sterilisation cycle the filter under test is integrity tested. Testing continues until the cartridge fails
integrity test and the steam life for that cartridge type is then defined from this data,
incorporating a safety margin.
Recommended maximum steam life for domnick hunter filter cartridges at a range of
temperatures is shown in Table 1. It should be noted that these are only provided as guidelines
as actual filter life will depend on individual steam sterilisation conditions.
The following sections in this guide provide step by step procedures for developing SIP
protocols in three operational conditions:
Each procedure has a system diagram and valve sequence table to illustrate the step by step
procedure. The procedures represent ideal systems for SIP, which may not be identical to
existing systems. For recommendations, modifications or more information regarding these
procedures please contact the domnick hunter Technical Support Group.
4. Steam-in-Place Procedures
See pages11-13.
across the filters and through valve V4 & V5. This will allow DRAIN
V1
the heating of the housing, the filters and associated pipework STEAM
without generating a significant differential pressure across Steam trap Steam trap
the filters. Note: The steam trap below valve V3 & V4 will DRAIN DRAIN
8. Ensure the steam pressure/temperature does not exceed the maximum allowable pressure/temperature for the cartridge type
being steamed. If reading from pressure gauges it is recommended the maximum steam pressure is 2.0 barg in the forward
direction.
9. Steam sterilise the cartridges for 30 minutes ensuring the conditions stated in steps 5 to 7 are followed. The valves should now
be in positions indicated for Steam-In-Place.
10. On completion of the Steam-In-Place cycle, close V4, V6, V3 and V1 in that order.
11. Slowly open V10 to release the steam pressure from the filter system and associated pipework. When the pressure on P2 reads
0.1 barg pressure close valve V10. Fully open valve V9 to release the remaining steam pressure from the filter system. When the
pressure on P1 reads 0.1 barg pressure, close valve V9.
12. Allow the system to cool for 30 minutes. The valves should now be in the positions indicated for post Steam-In-Place.
NOTES:
1. A double downstream valve (V7, V8) is recommended so that under the cartridge steaming protocol the valves sealing faces of V7 can be effectively sterilised. The
sealing valve faces of V8 can be similarly sterilised when the tank is steamed. When steam sterilising the tank, V7 would be closed and V6 and V8 open. Normally
the tank would be steamed separately before steaming the filter. If the filter is steamed before steaming the tank it is recommended that valve V7 is closed in the
post Steam-In-Place settings to maintain sterility. The valve V7 must be closed during Step 10.
2. Valve V7 should be installed horizontally and valve V6 / steam trap installed immediately downstream of V7.
3. All drains should be fitted vertically to allow liquid removal.
4. Large volume downstream systems should not be steam through the filter; e.g. when steaming process tanks a secondary steam supply should be used.
the filters. Note: The steam trap below valve V3 & V4 will V1
STEAM
receive the condensate and will repeatedly open and close.
Steam trap Steam trap
DRAIN DRAIN
4. When ‘live’ steam flows from valve V5, close valve V5. This
will direct the steam through the heated filter.
Valve Position
5. Observe the pressure gauges P1 and P2 and control the Code Valve Procedure V1 V2 V3 V4 V5 V6 V7 V8
V1 Steam Isolation Valve Pre SIP
steam flow rate at valve V3 to ensure the differential pressure V2 Inlet Air Isolation Valve SIP
V3 Steam Isolation Valve
does not exceed 0.2 - 0.3 barg. Post SIP
V4 Drain Valve
V5 Vent Valve
Key
V6 Drain Valve
6. When the steam trap below valve V6 closes, the steam V7 Downstream Isolation Valve
Valve Closed
Valve Open
pressure will begin to rise. V8 Downstream Isolation Valve
7. Ensure the steam pressure/temperature does not exceed the maximum allowable pressure/temperature for the cartridge type
being steamed. If reading from pressure gauges it is recommended the maximum steam pressure is 3.0 barg in the forward
direction.
8. Steam sterilise the cartridges for 30 minutes ensuring the conditions stated in steps 5 to 7 are followed. The valves should now
be in positions indicated for Steam-In-Place.
9. On completion of the Steam-In-Place cycle, close V4, V6, V3 and V1 in that order.
10a. Open V2 to allow compressed air into the system. The pressure of the air should be no more than 0.5 barg above the steam
pressure.
11. Allow the system to cool for 15 minutes, then close V5 (flash-dry only). The valves should now be in the positions indicated for
post Steam-In-Place.
NOTES:
1. A double downstream valve (V7, V8) is recommended so that under the cartridge steaming protocol the valves sealing faces of V7 can be effectively sterilised. The sealing valve
faces of V8 can be similarly sterilised when the tank is steamed. When steam sterilising the tank, V7 would be closed and V6 and V8 open. Normally the tank would be steamed
separately before steaming the filter. If the filter is steam before steaming the tank it is recommended that valve V7 is closed in the post Steam-In-Place prior to maintain sterility (step 9).
2. Valve V7 should be installed horizontally and valve V6 / steam trap installed immediately downstream of V7.
3. All drains should be fitted vertically to allow liquid removal.
4. Large volume downstream systems should not be steam through the filter; e.g. when steaming process tanks a secondary steam supply should be used.
5. Installation/use of domnick hunter air filter housings which utilise a plenum chamber are recommended, as this facilitates the collection and drainage of condensate.
6. When steaming in the reverse direction please contact domnick hunter for guidance.
5. When line steam flows from valve V6, close valve V6. When
Valve Position Valve Procedure V1 V2 V3 V4 V5 V6 V7
the steam trap below valve V5 closes, the steam pressure will Code Pre SIP
V1 Steam Isolation Valve SIP
begin to rise. V2 Steam Isolation Valve
Post SIP
V3 Downstream Isolation Valve
V4 Downstream Isolation Valve
Key
V5 Drain Valve
6. Ensure steam pressure/temperature does not exceed the V6 Vent Valve Valve Closed
Valve Open
maximum allowable pressure/temperature for the cartridge V7 Upstream Isolation Valve
7. Steam sterilise the cartridges for 30 minutes. The valves should now be in the positions indicated for Steam-In-Place. (This
method is typically suited to single cartridge systems).
8. On completion of the steam cycle time, close V5, V2, V1 in that order and then rapidly open V6 to flash dry the filter (or 8a).
8a. Isolate steam supply and open V7 to allow air into the system. The pressure of the air should be no more than 0.5 barg above
the steam pressure.
9. Allow the system to cool for 15 minutes then close V6, the valves should now be in positions indicated for post Steam-In-Place.
NOTES:
1. A double downstream valve (V4, V3) is recommended so that under the cartridge steaming protocol the valve sealing faces of V4 can be effectively sterilised - the sealing valve faces
of V3 can be similarly sterilised when the tank is steamed. When steam sterilising the tank V4 should be closed and valve V3 open. To ensure adequate drainage at V3, there should
be a slight fall in the pipework between V3 and the tank. As the same steam supply is used to sterilise the tank as well as the filter. A steam filter of a suitable flow rate capacity must
be selected.
2. All drains should be fitted vertically to allow liquid removal.
3. There should be a ‘fall’ in the pipework from V3 so that liquid can drain into the tank.
4. Large volume downstream systems should not be steamed through the filter; e.g. when steaming process tanks a secondary steam supply should be used.
5. Installation/use of domnick hunter air filter housings which utilise a plenum chamber are recommended, as this facilitates the collection and drainage of condensate.
6. Valve V7 should be placed as close as possible to the filter housing. If long lengths of pipe are present, the initial steam flows will be high as the downstream volume is pressurised.
This high steam flow can change the cartridge.
domnick hunter have a trained team of scientists and engineers available to answer questions
regarding the technical capabilities of our products, to assist in the selection and design of
appropriate filtration systems and to provide user training programs. The following services can
be delivered both on site and through our local domnick hunter offices:
For more information on any of the above support services please contact your local
domnick hunter representative.
email: tsg@domnickhunter.com
website: www.domnickhunter.com
domnick hunter limited domnick hunter gmbh domnick hunter pty ltd
Process Filtration Willich, Germany Boronia, Australia
Durham Road, Tel: +49 (0)2154 48100 Tel: +61 (0)3 9762 9922
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domnick hunter limited has a continuous policy of product development and although the Company reserves the right to change specification, it Website: http://www.domnickhunter.com
attempts to keep customers informed of any alterations. This publication is for general information only and customers are requested to contact
our Process Filtration Sales Department for detailed information and advice on a products suitability for specific applications. All products are sold Copyright domnick hunter limited 2002
subject to the company’s Standard conditions of sale. Publication Reference: PD93/11/02
Stock N°.: 17 950 1493
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