GE Healthcare

Steam Sterilization Handbook

Hollow fiber cartridges for membrane separations

18-1174-71 AA
Table of contents

Important safety considerations 5

Introduction
About this handbook 6
Target audience 6
Where to find more information 6
Getting help 6
Safety 6
Specific advice to help you work safely 6
Return authorization 7
Warranty 7
List of figures 8

Chapter 1—Housing design and assembly

Housing and cartridge design 9
Housing design 10
Membrane filter cartridge element design 10
How to install a membrane filter cartridge element in a housing 10
Installing an STM cartridge element in an STM housing 10
Installing an SMO cartridge element in an SMO housing 10
Installing an MSM cartridge element in an MSM housing 11
Where and how to install the filter 12
Where to install the housing 12
How to install the housing 13

Chapter 2—Expert tips

Introduction 14
General recommendations 15
Streamlining the steam-in-place process 15
Process design for effective sterilization 15

Chapter 3—Steam sterilizing procedure

The five SIP stages 16
Stage 1—Configure system for steaming 17
Stage 2—Introduce steam, flush, and hold 18
Stage 3—Cool and pressurize 19
Stage 4—Check filter integrity 20
Stage 5—Configure system for processing 21

Index 23

Steam Sterilization Handbook 3

4 Steam Sterilization Handbook
Important safety considerations
• Always ensure that all lines and components of your system
are steamable.

• Do not run steam through retentate side only. Steam must be

introduced equally on retentate and permeate sides—see
chapter 3 for complete steam sterilizing procedure.

• Ensure that no crimping, blockage, or unwanted valve shutoff

occurs, to prevent rupture or component failure.

• Ensure that steam traps are positioned at low point drains to

prevent condensate from cooling in the recirculation loop or
permeate at any point.

• Know—and do not exceed—the maximum operating pressure

of your system components.

• Monitor pressure with appropriate instrumentation during

sterilization.

• Install cartridges with all requisite O-rings, connectors,

and/or clamps.

• Develop and enforce standard operating procedures for

effective sterilization.

• Work to maintain sterility by ensuring that no contaminant

can enter the system prior to production.

• Check membrane filter cartridge and housing integrity after

sterilization—see page 20 for details.

• Ensure that all system valves, lines, and configurations are set for
processing before transitioning from sterilization to production.

• Steam that undergoes an abrupt expansion at high flow rates

can carry latent heat, commonly called “superheated steam.”
The high temperatures in superheated steam can cause
damage to polymers and elastomers. Superheated steam can
be avoided by properly reducing pressure through a sequence
of regulators. The steam pressure on the upstream side of the
regulator used to control the pressure on these membranes
should not exceed 2 barg (30 psig).

Steam Sterilization Handbook 5

Introduction Getting help
Contact GE Healthcare customer and technical support teams by
About this handbook calling 1-800-526-3593 in the USA, or by contacting your local
GE Healthcare office.
This handbook describes how to assemble, install, and steam
sterilize GE Healthcare STM, SMO, and MSM membrane filter
cartridges. Safety
This handbook shows the general system features necessary When using any laboratory, pilot scale, or production filtration
to comply with the steps outlined in the protocol presented. For equipment, the potential exists for personal injury unless you
example, the bypass valves that are used to warm the system follow established safety procedures. When using GE Healthcare
under low pressure conditions are critical to this sequence of test procedures and products, you should follow OSHA, federal,
operations. The membrane filter cartridge expands more than the state, and local safety mandates and regulations. You should
stainless steel housing and the warming process is necessary to follow your company’s safety procedures and the safety
avoid thermal stress that could lead to a breach of integrity. instruction provided in this handbook.

This handbook is designed for online viewing and navigation using This handbook uses highlighted text with safety flags to provide
Adobe® Acrobat®. Print the Acrobat file to obtain a hard copy. You safety information and expert advice:
can download this handbook from the GE Healthcare Web site.
 Safety
Target audience WARNING: A safety warning flag describes conditions
This handbook is intended for experienced users of microfiltration or actions that can cause bodily harm and describes
and ultrafiltration membrane filter cartridges. Specifically, the how to avoid the risk.
handbook addresses the needs of scientists, process engineers,
and technicians who operate research, laboratory, pilot, and
production filtration systems.
 Expert Advice
To use this handbook, you should know how to complete basic
technical procedures. For example, you should be qualified to set TIP: An expert advice tip flag provides information to
up laboratory and pilot equipment; measure temperatures, pres- use your hollow fiber membrane cartridge and system
sures, and flows; and understand filtration applications. If you do efficiently to achieve the best results.
not have these capabilities now, call GE Healthcare for assistance.
See “Getting help” on this page for contact information.

Specific advice to help you work safely

Where to find more information Potentially, the heat or pressure of steam can rupture a weakened
This handbook is a supplement to the Operating Handbook, or improperly assembled connection, kinked hoses or lines, and
Hollow fiber cartridges for membrane separations. In addition, other system components. Such a rupture can expose personnel
GE Healthcare publishes easy-to-use handbooks related to its to high pressure steam and cause severe injury.
cross flow filtration equipment. You can view and download
To avoid the unexpected rupture of a filter system or connection
these handbooks from our Web site, www.gehealthcare.com
due to improper assembly or overpressurization you should:

• Ensure you read the entire handbook before sterilizing a

cartridge with steam

• Ensure all system components are steamable

• Ensure all system components are assembled correctly

• Know—and do not exceed—the maximum operating pressure

of your system components

The Operating Handbook, Hollow fiber cartridges for membrane

separations, describes the maximum operating pressure of the
Figure 1. Other handbooks in the cartridge filter documentation set cartridge filters. To avoid exceeding the maximum operating
pressure and to monitor the sterilization process effectively, it is
Operating Handbook, Hollow fiber cartridges for membrane separations, a
downloadable handbook posted on our Web site and available in hard copy critical that you install pressure gauges on the system as
from GE Healthcare and its distributors described in this handbook.
Selection Handbook, Hollow fiber cartridges and systems for membrane separations,
a downloadable handbook posted on our Web site and available in hard copy from To avoid injury in the event of an unexpected steam leak, wear
GE Healthcare and its distributors appropriate personal protection gear in accordance with your
company’s safety policy (or national or regional regulations).

6 Steam Sterilization Handbook

Return authorization
To return a cartridge purchased from GE Healthcare in the USA,
call us at 1-800-526-3593 to obtain a return authorization number.
Clean, sanitize, and securely package cartridges before returning
them. Ship microfiltration cartridges dry. Include the details of its
operational history—for example, pages from a laboratory
notebook. Ship it prepaid to GE Healthcare Corporation, P.O. Box
1327, Piscataway, NJ 08855-1327, USA. We will repair or replace
defective cartridges. Outside the USA, you can contact your local
GE Healthcare representative using the telephone numbers listed
on the back cover of this handbook.

Warranty
GE Healthcare Corporation warrants its hollow fiber cartridges
to be free from defects in workmanship and materials for a period
of 30 days after the date of shipment from GE Healthcare or its
authorized dealers, provided that the cartridges have been operated
in accordance with GE Healthcare published specifications and
good engineering practices.

GE Healthcare shall have no liability under this warranty or other-

wise for improper application or abuse of the subject cartridge or
cartridges. This warranty is exclusive of all other implied warranties
including merchantability or fitness for a particular purpose.

The information contained in this handbook is not intended to constitute

any representation of warranty by GE Healthcare Corporation.

Steam Sterilization Handbook 7

List of figures
Figure 1. Other handbooks in the cartridge filter documentation set 6
Figure 2. Cutaway view of an STM cartridge element in an STM housing 10
Figure 3. Position of components of SMO membrane filter cartridge and housing 10
Figure 4. MaxCell™ MSM cartridge and housing 11
Figure 5. Typical installation of steam-in-place equipment 12
Figure 6. Connection specifications for representative sizes of STM, SMO, and MSM housings 13
Figure 7. Starting setup for Stage 1—configure system for steaming 17
Figure 8. Starting setup for Stage 2—introduce steam, flush, and hold 18
Figure 9. Starting setup for Stage 3—cool and pressurize 19
Figure 10. Starting setup for Stage 4—check filter integrity 20
Figure 11. Starting setup for Stage 5—configure system for processing 21

8 Steam Sterilization Handbook

Chapter 1

Housing design and assembly

This chapter describes:

• Housing and cartridge design

• How to install a cartridge in a housing

• Where and how to install a housing in your filtration system

Housing and cartridge design

GE Healthcare manufactures three models of steamable
housings and membrane filter cartridge elements identified by
model designations STM, SMO, and MSM. The SMO and STM
families are based on a 7.6-cm (3-in) diameter element. SMO
cartridges have an open face and a single O-ring seal at each
end. STM units have end caps at each face that neck down to
a double O-ring seal for connection to stainless steel end fittings.
Larger MSM steam-in-place (SIP) elements have a nominal
10.2-cm (4-in) diameter and an open face configuration.

Steam Sterilization Handbook 9

Housing design 3. Holding the cartridge at one end, push a retentate end cap
with 3-in gasket over the double O-rings at the other end of the
Housings are constructed of stainless steel and accept steamable, element. Repeat this process to install the gasket and retentate
replaceable membrane filter cartridge elements. O-rings and end end cap on the other end of the element.
plates seal the membrane filter cartridge element in the housing.
Sanitary connectors on the housing end plates enable connection 4. Clamp the housing using the supplied 7.6-cm (3-in) Tri-Clamps®.
to your filtration system (Fig 2).

Additional 0.5-in sanitary connections are used for low point

condensate drain and steam trap installation.

Membrane filter cartridge Figure 2. Cutaway view of an STM cartridge element in an STM housing

element design
Installing an SMO cartridge element in an SMO
Hollow fiber membranes are cast of polysulfone, and are designed
and tested for the temperatures and pressures required for auto-
housing
claving and steam-in-place sterilizing as described in this handbook. Follow these steps to install an SMO cartridge element into an
Membrane filter cartridges are machined of polysulfone also. The SMO housing (see Fig 3):
fiber bundles are held within the cartridge by coarse polypropylene
1. Place the stainless steel housing horizontally on a workbench
screens. Fibers are potted at each end in CFR-listed food grade
(see Fig 3 for positioning).
epoxy. All components conform to USP XXVII Class VI Biological
Test for Plastics. 2. Position an O-ring around one end of the cartridge and push it
into place using an end cap.
GE Healthcare supplies three families of steam-in-place designs:
STM, SMO, and MSM. The SMO and STM designs have a diameter
of 7.6 cm (3 in), while the MSM design is 10.2 cm (4 in). Each design
is unique and requires a dedicated, matching membrane filter
cartridge and housing. These devices are not interchangeable,
although each of the designs incorporates similar features.

How to install a membrane

filter cartridge element in a housing 3. Slide membrane filter cartridge (which now has one O-ring in
position) into one end of housing. Clamp end cap.
Installing an STM cartridge element in an STM
housing
Follow these steps to install an STM cartridge element into an STM
housing (see Fig 2):

1. Install double O-rings at each end of the cartridge.

4. Add a second O-ring as shown below and clamp end cap.

2. Place the stainless steel housing horizontally on a work bench

and slide the cartridge element into the housing.

Figure 3. Position of components of SMO membrane filter cartridge and housing

10 Steam Sterilization Handbook

Installing an MSM cartridge element in an MSM 3. Place the second O-ring in the groove and return the cartridge
to a vertical orientation (housing down/cartridge up) and push
housing
the cartridge down until centered in the housing.
Follow these steps to install an MSM cartridge element into an
MSM housing (see Fig 4):

1. Install an O-ring on the groove at one end of the cartridge

element. If the O-ring seems snug, moisten the O-ring with high
purity water for lubrication.

2a. To properly center the membrane filter cartridge inside the

housing, place the housing on a protective surface in a vertical
orientation. Pushing down on the face of the cartridge, force
the cartridge into the housing until the lower face makes 4. Secure the endplates with Tri-Clamp gaskets and clamps.
contact with the surface of the table.

Figure 4. Maxcell MSM cartridge and housing

The design of the MSM housing and retentate end cap requires a Tri-Clamp gasket
between the housing and end cap.

2b. Lay the cartridge in a horizontal position and continue to push

the cartridge into the housing until the O-ring groove emerges
 Expert Advice
from the other end.
TIP: Do not strike the cartridge face. Use only hand
pressure to apply a steady downward force.

Steam Sterilization Handbook 11

Where and how to install the filter  Expert Advice
Where to install the housing
TIP: We recommend that you connect the vent valve
To complete steam-in-place sterilization, you must integrate to an air line pressurized to about 1.03 barg (15 psig)
steam lines, steam traps, additional valves, and instrumentation to permit the use of an air “overpressure” condition
into the filtration system. Specific installation requirements and
at the end of the cycle, to ensure that no unsterilized
design can vary according to process variables; however, a
air can infiltrate the system.
typical setup includes a steam line piped into the retentate port
and a steam condensate line with a steam trap and isolation You should place a hydrophobic 0.2-micron micro-
valve piped into the feed line (Fig 5). porous filter in the vent line to maintain sterility.
You may be able to use steam traps as small as
0.25 in, depending upon the size of your system.

Steam to Retentate steam Air inlet/vent valve

retentate side inlet valve

Steam inlet
Retentate outlet
P Permeate steam inlet valve
Steam to
permeate side

Permeate outlet

Permeate outlet valve

GE Healthcare filter

Steam trap
bypass valve
Low-point
permeate drain Closed valve

Steam trap
isolation valve Partially open valve
P
Feed inlet
ST Open valve

Steam trap Steam trap

isolation valve Condensate P Pressure gauge
bypass valve
ST ST Steam trap

Condensate
0.2 micron filter (optional)

Figure 5. Typical installation of steam-in-place equipment

12 Steam Sterilization Handbook

How to install the housing
Pipe the housing into your system using established standards
for piping and pipe support. Consult national, regional, local, and
your company’s piping regulations and guidelines.

Steamable housing models STM, SMO, and MSM use sanitary

connectors to connect feed, retentate, permeate, drain, and
vent ports. Connect the ports to your system using sanitary
connectors, O-rings, and Tri-Clamps (Fig 6).

Housing 35STM Housing 45MSM-DP

Length = 43.4 cm (17.1 in) Length = 52.8 cm (20.8 in)
Diameter = 9.1 cm (3.6 in) Diameter = 11.4 cm (4.5 in)
Permeate ports = 1.5-in Tri-Clamp Permeate ports = 1.5-in Tri-Clamp
Feed/retentate ports = 1.5-in Tri-Clamp Feed/retentate ports = 2-in Tri-Clamp
Drain/vent ports = 0.5-in Tri-Clamp Drain port = 0.5-in Tri-Clamp

Housing 55STM Housing 65MSM-DP

Length = 75.2 cm (29.6 in) Length = 75.7 cm (29.8 in)
Diameter = 9.1 cm (3.6 in) Diameter = 11.4 cm (4.5 in)
Permeate ports = 1.5-in Tri-Clamp Permeate ports = 1.5-in Tri-Clamp
Feed/retentate ports = 1.5-in Tri-Clamp Feed/retentate ports = 2-in Tri-Clamp
Drain/vent ports = 0.5-in Tri-Clamp Drain port = 0.5-in Tri-Clamp

Housing 85MSM-DP
Length = 134 cm (52.7 in)
Diameter = 11.4 cm (4.5 in)
Permeate ports = 1.5-in Tri-Clamp
Feed/retentate ports = 2-in Tri-Clamp
Drain port = 0.5-in Tri-Clamp

Optional elbow adapters are available for

Housing 35SMO-DP 85MSM stainless steel housing
Length = 37.3 cm (14.7 in) (SS-85MSM-EL-DP)
Diameter = 9.1 cm (3.6 in)
Permeate ports = 1.5-in Tri-Clamp
Feed/retentate ports = 1.5-in Tri-Clamp
Drain port = 0.5-in Tri-Clamp

Housing 55SMO-DP
Length = 69.3 cm (27.3 in)
Diameter = 9.1 cm (3.6 in)
Permeate ports = 1.5-in Tri-Clamp
Feed/retentate ports = 1.5-in Tri-Clamp
Drain port = 0.5-in Tri-Clamp

Figure 6. Connection specifications for representative sizes of STM, SMO, and MSM housings

Steam Sterilization Handbook 13

Chapter 2

Expert tips

Introduction
In many cross flow filtration applications—particularly in the
pharmaceutical and biotechnology fields—the sterility of the filter
must be ensured before using it. Steaming-in-place is one
method to sterilize cartridge filters. Steaming-in-place requires
the proper equipment, operated properly and consistently, to
ensure complete sterilization and validation. Therefore, the goal
of this chapter is to provide recommendations and techniques to
help ensure efficient and effective steam sterilization.

14 Steam Sterilization Handbook

General recommendations
Streamlining the steam-in-place process
From an operational standpoint, here are some steps that can be
taken to streamline the steam-in-place process:

• Permanently install the steam-in-place components on the

filtration system to save setup time and not disturb the
process system.

• Ensure all components in the system, such as values and

pressure gauges, are steamable by reviewing equipment
specifications. Using steamable process equipment ensures
safety and minimizes component replacement and
maintenance.

Process design for effective sterilization

Cartridge integrity and proper sterilizing steps are required to help
ensure sterilization.

Establish, through trials, a sterilization procedure that provides

the desired results. Validate this procedure, and write and use
standard operating procedures (SOPs) for consistency.

Superheated steam can overheat the cartridge, causing damage

to the cartridge or influencing membrane performance. Ensure
the temperature and quality of the steam is consistent.

As part of your SOP, check all valve positions before operating or

steam cleaning your system.

Do not induce a backpressure on the membrane cartridge.

Steam Sterilization Handbook 15

Chapter 3

Steam sterilizing procedure

The five SIP stages

To steam sterilize a GE Healthcare STM, SMO, or MSM cartridge
assembly in a steam-in-place application, inject steam into both
the feed and permeate ports using the steps and process
conditions described below. Steam penetrates both sides of
the filter membrane and condensate exits from two low-point
steam traps.

There are five stages:

1. Configure system for steaming

2. Introduce steam, flush, and hold

3. Cool and pressurize

4. Check filter integrity

5. Configure system for processing

 Safety
WARNING: GE Healthcare filter cartridges and stain-
less steel housings are steamable. If other compo-
 Safety
nents in your filtration system are not designed to
withstand steaming, they can rupture, causing injury The following procedure is specific to steam-in-
from projectiles and live steam. To prevent injury due place of the cartridge and housing only. When
to rupturing, ensure all components in the system— steaming-in-place large process vessels or process
such as valves and pressure gauges—are steamable. systems with a large void volume, it is recommended
Confirm steamability by reviewing equipment specifi- that the steam line be introduced separately from
cations. If a steam leak occurs and personnel are not the filter. It is possible to introduce steam into
wearing proper personal protection, severe injury can small process systems via one steam line, however
result. Wear appropriate personal protection gear in this must be done very carefully and slowly to pre-
accordance with company safety policy, or national vent reverse steam pressure on the filter cartridge.
or regional regulations.

16 Steam Sterilization Handbook

Stage 1—Configure system for steaming
Configure the system for steaming (see Fig 7) as follows:

1. Ensure all glycerine is removed from ultrafiltration cartridges.

2. Isolate the steam traps.

3. Close the feed inlet, permeate outlet, low-point permeate drain,

retentate outlet, and air inlet/vent valves.

4. Open the retentate and permeate inlet steam valves.

5. Open the feed steam trap bypass valve.

6. Close the permeate steam trap bypass valve.

Steam to Retentate steam Air inlet/vent valve

retentate side inlet valve
Steam inlet
Retentate outlet
P Permeate steam inlet valve

Steam to permeate side

Permeate outlet
Permeate outlet valve

GE Healthcare filter

Steam trap
bypass valve
Low-point
permeate drain Closed valve

Steam trap
isolation valve Partially open valve
P
Feed inlet
ST Open valve

Steam trap Steam trap

isolation valve Condensate P Pressure gauge
bypass valve
ST ST Steam trap

Condensate 0.2 micron filter (optional)

Figure 7. Starting setup for Stage 1—configure system for steaming

Steam Sterilization Handbook 17

Stage 2—Introduce steam, flush, and hold Steam flush—slowly increase the pressure
4. Open the process retentate valve slightly.
Steam the cartridge following these steps:
5. Slowly open the main steam inlet valve.
Introduce steam
1. Crack open the steam inlet valve or adjust regulator to 6. Let the pressure increase, but do not exceed 1.03 barg (15 psig).
0.07 barg (1 psig). Steam and water should trickle from the
steam trap bypass valve (feed). Adjust the steam inlet valve so
Hold steam at pressure
7. Open the process feed, retentate outlet, and permeate outlet
that the system outlet temperature reaches about 100°C
valves slightly.
(212°F) in five to ten minutes (Fig 8).
8. If introducing steam to the remainder of a small process
2. Once the system outlet temperature reaches 100°C, wait five
system, slowly open the retentate outlet and feed inlet valves,
minutes and open the permeate steam trap bypass valve. Wait
ensuring the steam pressure does not drop. When the remainder
five more minutes. Close both steam trap bypass valves.
of the process system comes up to pressure, fully open the
3. Open the steam trap isolation valves, maintaining steam flow retentate outlet and feed inlet valves.
into both sides (retentate and permeate) of the filter.
9. Steam for 30 minutes at the specified pressure.
Condensate will drain from the steam traps.

Steam to Retentate steam Air inlet/vent valve

retentate side inlet valve
Steam inlet
Retentate outlet
P Permeate steam inlet valve

Steam to
permeate side

Permeate outlet
Permeate outlet valve

GE Healthcare filter

Steam trap
bypass valve
Low-point
permeate drain Closed valve

Steam trap
isolation valve Partially open valve
P
Feed inlet
ST Open valve

Steam trap Steam trap

isolation valve Condensate P Pressure gauge
bypass valve
ST ST Steam trap

Condensate
0.2 micron filter (optional)

Figure 8. Starting setup for Stage 2—introduce steam, flush, and hold

18 Steam Sterilization Handbook

Stage 3—Cool and pressurize Note: It is recommended that the vent valve be connected to air
pressure adjusted to approximately 1.03 barg (15 psig).
Cool the cartridge element and housing following these steps:
Maintaining positive pressure will assure that no unsterilized air
1. Close the steam inlet valve (Fig 9). infiltration will occur anywhere in the system. A sterile, 0.2-micron
hydrophobic filter must be positioned in the vent line to maintain
2. Release the pressure by opening one of the steam trap bypass
sterility.
valves and slowly opening the air inlet/vent valve.

3. Allow the cartridge and system to cool to ambient temperature.

Typically cooling requires about four hours at ambient
temperature.

Steam to Retentate steam Air inlet/vent valve

retentate side inlet valve
Steam inlet
Retentate outlet
P Permeate steam inlet valve
Steam to
permeate side

Permeate outlet
Permeate outlet valve

GE Healthcare filter

Steam trap
bypass valve
Low-point Closed valve
permeate drain
Steam trap Partially open valve
P isolation valve
Feed inlet
ST Open valve

Steam trap Steam trap

isolation valve Condensate P Pressure gauge
bypass valve
ST ST Steam trap

Condensate
0.2 micron filter (optional)

Figure 9. Starting setup for Stage 3—cool and pressurize

Steam Sterilization Handbook 19

Stage 4—Check filter integrity 2. Attach flexible tubing to permeate steam trap bypass valve and
immerse in a beaker of water.
Checking the integrity of the filter is optional, but recommended
and sometimes required in many applications. See the 3. Perform pressure hold integrity test by introducing air at
GE Healthcare Integrity testing handbook for additional details. approximately 0.34 barg (5 psig) through the air vent. Watch for
The basic steps to complete integrity testing include: bubbles emanating from the permeate drain.

1. Close all valves except the air inlet/vent valve, retentate steam 4. If only small bubbles emanate, the cartridge has integrity.
inlet valve, and permeate steam trap bypass valve (Fig 10).

Steam to Retentate steam Air inlet/vent valve

retentate side inlet valve
Steam inlet
Retentate outlet
P Permeate steam inlet valve

Steam to permeate side

Permeate outlet
Permeate outlet valve

GE Healthcare filter

Steam trap
bypass valve
Closed valve

Steam trap Partially open valve

P isolation valve
Feed inlet
ST Open valve

Steam trap Steam trap

isolation valve Condensate P Pressure gauge
bypass valve
ST ST Steam trap
Condensate
0.2 micron filter (optional)

Figure 10. Starting setup for Stage 4—check filter integrity

20 Steam Sterilization Handbook

Stage 5—Configure system for processing
Follow these steps to configure the system for processing:

1. Close the air inlet/vent valve, retentate, and permeate steam

inlet valves, steam trap isolation valves, and steam trap bypass
valves.

2. Open feed inlet valve, permeate outlet valve, and retentate

outlet valve.

3. The system is now ready for processing.

Steam to Retentate steam Air inlet/vent valve

retentate side inlet valve
Steam inlet
Retentate outlet
P Permeate steam inlet valve

Steam inlet to permeate side

Permeate outlet
Permeate outlet valve

GE Healthcare filter

Steam trap
bypass valve
Low-point Closed valve
permeate drain
Steam trap
Partially open valve
P isolation valve
Feed inlet
ST Open valve

Steam trap Steam trap

isolation valve Condensate P Pressure gauge
bypass valve
ST ST Steam trap

Condensate
0.2 micron filter (optional)

Figure 11. Starting setup for Stage 5—configure system for processing

Steam Sterilization Handbook 21

22 Steam Sterilization Handbook
Index F

A Filter cartridge element design, 9

About this handbook, 6 Filter integrity testing, 20

Additional information, 6 Flow diagrams

Stage 1—configure system for steaming, 17

C Stage 2—introduce steam, flush, and hold, 18

Stage 3—cool and pressurize, 19
Cartridge design, 9
Stage 4—check filter integrity, 20
Cartridge element installation, 10,11,12,13
Stage 5—configure system for processing, 21
Cartridge filter documentation set, 6
Typical installation of steam-in-place equipment, 12
Check filter integrity, 20
Configure system for processing, 21
H
Configure system for steaming, 17
Connection specifications, 13 Handbook introduction, 6

Contact information, 6 Handbooks, 6

Cooling after steaming, 19 Help, 6

Customer support, 6 Housing

Connector specifications, 13
How to install the housing, 13
D
Installation location, 12
Drawings
Housing and cartridge design, 9
Connection specifications for representative sizes of STM,
Housing design, 10
SMO, and MSM housings, 13
Housing design and assembly, 9
MSM cartridge element installation, 11
MSM cartridge and housing design, 11
I
SMO cartridge components position, 10
SMO cartridge element installation, 10 Important safety considerations, 5

STM cartridge element installation, 10 Information sources, 6

STM cartridge and housing design, 10 Installation

Documentation set, 6 Connector specifications, 13

How to install the housing, 13

E MSM cartridge element, 11

SMO cartridge element, 10
Expert advice, 6
STM cartridge element, 10
O-ring installation, 11
Where to install the housing, 12
Steam trap sizing, 12
Installing a membrane filter cartridge element in a housing,
Expert advice flags, 6
10,11,12,13
Expert tips, 14
Introduce steam to the system, 18
Introduction, 14
Introduction, 6
General recommendations, 15
Introduction to steaming-in-place, 14
Process design for effective sterilization, 15
Streamlining the steam-in-place process, 15
K

Knowledge required to use equipment. see Target audience, 6

Steam Sterilization Handbook 23

L Stage 4—Check filter integrity, 20

List of figures, 8 Stage 5—Configure system for processing, 21

Figure 1. Cartridge filter documentation set, 6 SMO cartridge element installation, 10

Figure 2. Cutaway view of an STM cartridge element in an SOP, 15

STM housing, 10
Specific advice to help you work safely, 6
Figure 3. Position of components of SMO membrane filter
Steam trap sizing, 12
cartridge and housing, 10
Steaming
Figure 4. MaxCell MSM cartridge and housing, 11
Specific safety precautions, 16
Figure 5. Typical installation of steam-in-place equipment, 12
Standard operating procedures. see SOP, 15
Figure 6. Connection specifications for representative sizes of
STM, SMO, and MSM housings, 13 Steam-in-place

Figure 7. Starting setup for Stage 1—configure system for Check filter integrity, 20
steaming, 17
Configure system for processing, 21
Figure 8. Starting setup for Stage 2—introduce steam, flush,
Configure system for steaming, 17
and hold, 18
Cool and pressurize, 19
Figure 9. Starting setup for Stage 3—cool and pressurize, 19
Ensuring effective sterilization, 15
Figure 10. Starting setup for Stage 4—check filter integrity, 20
Expert tips, 14
Figure 11. Starting setup for Stage 5—configure system for
processing, 21 Five stages, 16
Streamlining the process, 15

M Steaming the cartridge element, 18

MSM cartridge element installation, 11 Steam-in-place procedure, 16

Membrane filter cartridge element design, 10 Steaming precautions, 16

Steam sterilizing procedure, 16

O Sterilization, 15

Operator skill level. see Target audience, 6 STM cartridge element installation, 10
Streamlining the steam-in-place process, 15

Precautions (general), 6 T

Precautions (steaming), 16 Table of contents, 3

Process design for effective sterilization, 15 Target audience, 6

Technical support, 6

R Tips, 14

Return authorization, 7
U

S User skill level. see Target audience, 6

Safety, 6
Safety flags, 6 W

Safety precautions, 6 Warranty, 7

SIP stages, 16 Web site, 6

Stage 1—Configure system for steaming, 17 Where to find more information, 6

Stage 2—Introduce steam, flush, and hold, 18

Stage 3—Cool and pressurize, 19

24 Steam Sterilization Handbook

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