Sartorius Stedim Biotech Sartocube User manual

User Manual | Bedienungsanleitung
Sartocube®| Sartocon®| Sartocon® Slice
Sartocon® Slice 200 Cassettes
White Silicone | Weißes Silikon
85032-541-09
85032-541-09 Vers. 03 | 2014

Contents of this Manual |
Inhalt dieser Anleitung
Legal Notices | Impressum .............................. Page | Seite 2
English .............................................. Page 2
Deutsch .............................................. Seite 29
If you require further information on crossflow filtration, other than mentioned in
this User Manual, please contact us.
Reproduction, translation and duplication in any form, in part or in full, requires
the written permission of the Sartorius Stedim Biotech GmbH.
For technical information write to:
Sartorius Stedim Biotech GmbH
August-Spindler-Strasse 11
D-37079 Goettingen
Internet: www.sartorius-stedim.com
Edition: March 2014
Order No.: 85032-541-09
Wenn Sie verbindliche Informationen zu bestimmten Eigenschaften Ihrer Crossflow
Cassetten benötigen, welche über die hier beschriebenen hinaus gehen, bitten wir um
Ihre Anfrage.
Nachdruck, Übersetzung und Vervielfältigung in jeglicher Form, auch auszugsweise,
bedürfen der schriftlichen Genehmigung der Sartorius Stedim Biotech GmbH.
Adresse der Technischen Dokumentation:
Sartorius Stedim Biotech GmbH
August-Spindler-Strasse 11
D-37079 Göttingen
Internet: www.sartorius-stedim.com
Germany
Version: März 2014
Bestellnummer: 85032-541-09
2

Contents 3
Contents
1. General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.1 Instructions to this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.2 Storage of unused cassettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3 Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4 Components of a Crossflow System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
2. Start Up Of Cassettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1 Installing Filter Cassettes in a Holding Device . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2 Clamp Force for Sartorius Stedim Biotech Cassettes . . . . . . . . . . . . . . . . . . . . 10
2.3 Flushing the Cassettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.4 Integrity Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.4.1 Manual Integrity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.4.2 Automatic Integrity Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.5 Determining Clean Water Flux for Filter Cassettes . . . . . . . . . . . . . . . . . . . . . 14
2.6 Thermal Sterilization of Filter Cassettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
2.6.1 In Line Steam Sterilization of Sartocon® Microfilter Cassettes . . . . . 16
2.6.2 In Line Steam Sterilization of Sartocon® Ultrafilter Cassettes . . . . . . 18
2.6.3 Autoclaving the Filter cassettes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
2.7 Filtration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
2.8 Cassette Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2.9 Cassette Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
2.10 Cassette Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
2.11 Cassette Return Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
2.12 Cassette Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
3. Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.1 Specifications Sartocon® Slice 200 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.2 Specifications Sartocon® Slice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3.3 Specifications Sartocon® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3.4 Specifications Sartocube® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

4 General
1.1 Instructions to this manual
1.2 Storage of unused
cassettes
1. General
t Please be sure to read this user manual prior to use of equipment.
t Please read all safety instructions.
t This user manual is part of the product. Keep it in a safe place
for future reference.
t Replacement manuals can be requested by telephone or it can be downloaded
from our Webpage at: www.sartorius-stedim.com
Symbol
The following symbols are used in this user manual:
This symbol indicates situations in which improper procedure could lead
to personal injury.
This symbol indicates that the preservative is not suitable for consumption.
This symbol indicates situations in which improper procedure could lead
to equipment damage.
This symbol draws attention to additional information.
The latest date of usage is 3 years from date of manufacture.
The following conditions have to be maintained during storage in order to guarantee
full cassette functionality:

Cassettes must be stored in a closed dry area.

Temperature has to be between 5°C to 40°C and absolutely frost free.

No direct solar radiation.

No direct contact with moisture.

Any mechanical influence or damage must be prevented.
Products with damaged packaging should be discarded.


The preservative is not suitable for consumption.

During in-line sterilization of the holding device with hot steam, the entire system
becomes very hot. Do not touch any part of the system with your bare hands. If you
need to handle any part of the system, wear heavy safety gloves to avoid getting
severely burned.

During in-line steam sterilization, hot steam exits from the feed inlet and from the
permeate outlets. Keep a safe distance to these outlets and do not try to reach inside
them; as there is a serious risk of severe burns.

Do not apply more than the torque given in the ”Specifications”. Torquing the filter
cassettes too tightly will damage them.

The maximum inlet pressure must not be exceeded (see ”Specifications“).
Over pressurizing will damage the filter cassettes.

Before thermal sterilization, exchange the torque nuts for normal operation to the
torque nuts for pressure compensation. These pressure compensation torque nuts
keep the torque constant even when the temperature fluctuates. If the pressure com-
pensating torque nuts are not used, the torque will increase beyond the maximum
allowable compression during thermal sterilization, causing irreversible damage to
the filter cassettes.

Do not allow any type of filter cassette to dry out to avoid loss of filtration
properties.

Make sure that the filter cassettes you plan to use have the required chemical com-
patibility before beginning a filtration run in order to avoid damaging the mem-
branes. If you are not sure about the compatibility of a filter cassette with a certain
chemical, please consult your nearest Sartorius Stedim Application specialist.

Do not combine cassettes with white and gray silicone encapsulation in one
holding device.

Avoid abrupt changes in pressure (approximately > 1 bar/sec), such as those that can
occur when the pump is switched on or when the valves settings are changed.

Keep vibration to the lowest level that is technologically possible.

The effective torque on hydraulic holding devices should be kept constant, especially
when the holding device is installed in a large filtration system.

The maximum allowable back pressure on the permeate side must not exceed 0.5 bar
for Hydrosart® UF and 1 bar for PESU max and Hydrosart® open channel cassettes.

The outer silicone sealing of cassettes should be washed of with DI water,
after submerged storage, before installation into a cassette holding device.
General 5
1.3 Safety instructions

Sartocon® Slice 200
Sartocon® Slice Cassette
Retentate backpressure is defined as follows:
Permeate pressure is higher than the Retentate pressure
Pperm > P ret ;
P back = Pperm - P ret .
Hydrostatic pressure on the permeate side (height and the inner diameter of the
filtrate tubing) has an impact on backpressure.
Please make sure that the maximum backpressure pressure is never exceeded.
Note
This has to be distinguished from Transmembrane Pressure.
Transmembrane pressure (TMP):
TMP = [(pfeed + pret)/2] - pperm
and from Differential Pressure:
Δp = pfeed - pret
Feed pressure (pfeed) and retentate pressure (pret), both measureable with a gauge.
Permeate pressure (pperm) is the average pressure on the permeate side, measureable
with a gauge.

If the possibility of crystalline particles entering the cassettes cannot be completely
ruled out (for example, due to abrasion in the pumps), a prefilter must be used.

Make sure that crystallization caused by changes in temperature or concentration
cannot occur during operation or storage.

Do not combine cassettes that have a different feed inlet design. Sartocon cassettes
have alternating oval and round ports.

Install the filter cassettes in the appropriate holding device only. You will need either
a Sartocon® Slice, Sartocon® 2 plus or a SARTOFLOW® holding device, depending on
the type and amount of filter cassette you plan to use. If you wish to use holding
devices supplied by other manufacturers, you may need to apply a different torque
pressure when installing cassettes. To avoid damaging the cassettes, please contact
our application specialist.

Make sure that the correct crossflow conditions are maintained during filtration. Oth-
erwise, the flux rate of the filter cassettes will decrease rapidly during filtration under
static conditions (dead-ended filtration) (refer to “Filtration”).

The temperature of the retentate must not exceed that given for continuous
operation, which is listed in the “Specifications.” During crossflow filtration, the
temperature will increase over time because the kinetic energy of the pump is
transferred to the liquid undergoing filtration. If the temperature increases beyond
that indicated in the “Specifications,” the pressure resistance of the crossflow system
will decrease.
6 General

Sartocon® Cassette
Sartocube®

You should use a prefilter. This will enhance the flux rate and increase the service life
of the filter cassettes.

You should clean the filter cassettes after every filtration run. During filtration a
layer caused by fouling builds up on the membranes. Over time, this layer becomes
compacted, making it difficult to remove completely. As a result, the flux rate of your
filter cassettes will decrease.

All filter cassettes used in one holding device must have identical membranes.

If you do not need to use filter cassettes for a relatively long period, you should store
them in a solution that contains a preservative. This will protect the filter cassettes
from microbial contamination and from drying out.

Do not attempt to operate the filtration system with accessories or spare parts other
than those supplied by the original manufacturer. In the event that the filtration
system is tampered with in any way, we cannot guarantee or take any responsibility
for the performance or safety of the system. This may also endanger the safety of the
operator.

Use only materials recommended by the manufacturer (e.g. gaskets, tubing or hoses).
General 7













Holding Device
SARTOFLOW® 10 Holder
1–10 Cassettes
Sartocon Slice 200 (Holder for
max. 2 Slice 200 Cassettes)
Mat. No. #17525---01
Sartocon Slice
(for 1-5 Slice Cassette Holder
[Sartoflow Alpha])
Mat. No. #17521---002
Sartocon Slice (for 1-3 Slice
Cassette Holder) Mat. No.
#17521---001 Need for No. #:
1ZLI-V0001 additional long-
spacers to run a Slice 200 cassette
Sartocon® 2 plus 1–10 Cassettes
[Order Nr.: 17546*]
SARTOFLOW® 20 Holder
2–20 Cassettes
1.4 Components of a
Crossflow System
8 General













2.0 Start up of cassettes
2.1 Installing Filter Cassettes in a To install the cassettes in a Sartorius Stedim Biotech holding device,
Holding Device proceed as follows:
1. Remove filter cassette from its packaging.
2. Check and record cassette labelling.
3. Place the filter cassette with the semi-circular cutouts facing downward on the
two guide rods between the two holding plates.
4. Alternately tighten the compression nuts until the filter cassette(s) is (are) secured
in place by the holding plates.
5. Use a torque wrench to tighten the copression nuts alternately to the torque
specified. Please see ”Clamp Force for Sartorius Cassettes“.
6. After 15 minutes, check the torque and, if necessary, re-adjust to the torque
specified.
Do not torque the holding device beyond the torque specified.
Keep the threads of the holding device clean to ensure adequate torque.
Semi-circular cutouts
Sartocon® 2 plus
[Order Nr.: 17546*]
Pressure compensating torque nuts
Guide rods
Start up 9

2.2 Clamp Force for Sartorius Stedim Biotech Cassettes
Sartocon® Slice 200 Holding Device, Manual closure
Required Compression Torque applied on Tie Rods with a Torque Wrench
Operating Conditions Sterilization* Operating Conditions Sterilization*
PESU UF | MF 18–21 kN No thermal 25 Nm No thermal
Sartocon® Slice 200 Cassettes sterilization sterilization
308146… | 308154...
PESUmax (308146AL…) 25 kN No thermal 25 Nm No thermal
sterilization sterilization
Hydrosart® UF | MF 14–17 kN No thermal 20 Nm No thermal
Sartocon® Slice 200 Cassettes sterilization sterilization
308144… | 308186…
Sartocon® Slice Holding Device, Manual closure
Required Compression Torque applied on Tie Rods with a Torque Wrench
Operating Conditions Sterilization* Operating Conditions Sterilization*
Sartocon® Slice 18–21 kN < 2 kN 25 Nm first notch
Cassettes MF | UF
305146… | 305154…
PESUmax 305146AL… 18–21 kN No thermal 25 Nm No thermal
sterilization sterilization
Hydrosart® MF | UF
Sartocon® Slice
305144… | 305186… 14–17 kN < 2 kN 20 Nm first notch
Sartocon® 2 plus Holding Device, Manual closure
Required Compression Torque applied on Tie Rods with a Torque Wrench
Operating Conditions Sterilization* Operating Conditions Sterilization*
Sartocube® and 18–35 kN < 10 kN 80 Nm first notch
Sartocon® Cassettes
302146... | 302154…
PESUmax 302146AL… 21–35 kN No thermal 80 Nm No thermal
sterilization sterilization
Hydrosart® MF | UF 18–25 kN < 10 kN 60 Nm first notch
Sartocube® and
Sartocon® Cassettes
302144… | 302186…
Sartoflow® 10 | Sartoflow® 20 and Sartoflow® Systems with Hydraulic Piston, 12.5 cm2
Required Compression Hydraulic Pressure
Operating Conditions Sterilization* Operating Conditions Sterilization*
Sartocube® and 18–35 kN < 10 kN 170 bar (2466 PSI) 80 bar (1160 PSI)
Sartocon® Cassettes (17 MPa) (8 MPa)
302146... | 302154…
PESUmax 302146AL… 21–35 kN No thermal 170 bar (2466 PSI) No thermal
sterilization (17 MPa) sterilization
Hydrosart® MF | UF 18–25 kN < 10 kN 170 bar (2466 PSI) 80 bar (1160 PSI)
Sartocube® and (17 MPa) (8 MPa)
Sartocon® Cassettes
302144… | 302186…
* List of sterilizable cassettes is available in “Specifications”, section 3.1.
10 Clamp Force

Flushing 11
2.3 Flushing the Filter Cassettes Flush the filter cassettes as indicated below:
t Before initial use with purified water
t With buffer or physiological saline before filtration
t With buffer or physiological saline before cleaning
t With purified water after cleaning
t With purified water after disinfection
t With purified water before checking the functionality of the filter cassettes
t With purified water before sterilization
Flush Procedure for Cassettes
The installed cassettes must be flushed with purified water or RO water at the
recommended approx. ratio of retentate to permeate flow as listed below.
Cassette Type Ratio of Retentate to
Permeate flow
Ultrafilters 1 kD | 2 kD Approx. 5 : 1
Ultrafilters 5 kD Approx. 3 : 1
Ultrafilters 8 kD up to 300 kD and
Microfilters 0.1 µm Approx. 1 : 1
Microfilters 0.2 µm and 0.45 µm and PESU MAX Approx. 1 : 2
The cassette must be flushed with 10 l purified of water per 0.1 m2 filter area.

2.4 Integrity Testing For multiple cassette integrity testing see ”#1 Technical Data Package Integrity
testing Sartocon® Cassettes“.
Ensure the filter cassettes are sufficiently wet before measuring the
air diffusion.
2.4.1 Manual Integrity Test Proceed as follows:
1. Attach a hose to the feed inlet (V1), and connect the other end of the hose to
a compressed air source.
2. Close the retentate outlet (V2).
3. Adjust the inlet test pressure pinlet to the value specified (see ”Specifications“
section 2.16), and keep this pressure constant.
4. Close the lower permeate outlet valve V3.
5. At a constant inlet pressure pfeed, wait four minutes until the system
has stabilized.
6. Use a flow meter or an inverted burette filled with water to measure the air
diffusion at the upper permeate outlet.
12 Manual Integrity Test
V4
Retentate valve
outlet closed
Compressed air Feed
Inlet
V2
P2
P1
P3V3
Permeate
closed
Cassette
V1
Permeate
open
Fig. 1: System set up for manual integrity testing

Integrity Test 13
2.4.2 Automatic Integrity Test Proceed as follows:
(Pressure Decay)
1. Connect the integrity tester [such as Sartocheck® 3 plus (16290) or Sartocheck® 4
Plus (26288)] to the power supply and pressure source.
2. Close the retentate outlet (V2) and open the permeate outlets (V3, V4). Open V5 and
close V1.
3. Enter the required test parameter according to the Sartocheck® instruction manual
and cassette data.
4. Use the following parameter:
stab. time: 4 min.
test time: 2 min.
5. Enter the maximum allowable diffusion value (see "Specifications ").
6. Start the Integrity Test.
If the hold up volume exceeds 9 l, please contact your Sartorius Stedim
application specialist.
Fig. 2: System set up for automatic integrity testing. V1–V5: valves; P1–P3: pressure gauge.
Sartocheck®
Retentate outlet
closed
V5
V2
Pump V1V4
V3
Feed inlet
closed
Permeate open
Permeate open
Cassette
P1
P2
P3

2.5 Determining Clean Water Flux for The water flux test is an easy and non-destructive test that measures the ability
Filter Cassettes (CWF) of water to pass through the membrane in a specific system setup. Residuals on the
membrane surface will impact water flux rates. Determining the water flux rate
enables the user to confirm the ability of a cleaning cycle to restore filtration rate of
the system. The water flux should be trended over time and evaluated for potential
membrane and system changes.
It cannot be used to assess the removal of preservative, cleaning or process residue.
Specific analytical techniques are required to quantify residues.
Determine a clean water flux
Proceed as follows:
1. Rinse new installed cassettes to remove preservatives.
2. Post use sanitization cassettes with 1 N Sodium hydroxide and neutralize.
3. Run the clean water flux with purified water as specified in the table below.
4. Measure retentate rate and permeate rate at constant temperature (20°C).
5. Trend the clean water flux and water flux determined after cleaning to detect
membrane and system changes. The clean water flux is used as the base line value.
Any changes in water quality, applied pressure, temperature and viscosity,
system design and membrane, will have an effect on the water flux.
In systems containing more than one Sartocon® or a Sartocube®, the interpretation can
be simplified by establishing a baseline for a given set of devices in a given system.
Flow path restriction may not allow performing the flux test with the above-men-
tioned parameters. In that case a different test pressure should be used to perform a
water flux test. Once the parameters are defined they have to remain constant during
every test to assure comparability.
System Pressure Examples for Water Flux Determination:
Cassette Design Feed Pressure Retentate Permeate Pressure
valve open Pressure valve open
[psi|bar|kPa] [psi|bar|kPa] [psi|bar|kPa]
Sartocon® Slice 29|2|200 7|0.5|50 0|0|0
Cassette and
Slice 200
Sartocon® Cassette 29|2|200 7|0.5|50 0|0|0
Multiple Sartocon® 29|2|200 10–14|0.7–1|70–100 < 7|0.5|50
Cassettes
Sartocube® Cassette 29|2|200 10–14|0.7–1|70–100 < 7|0.5|50
14 Clean Water Flux

Sterilization 15
Although the flux rate of used filter cassettes will normally not be fully regained,
the flux rate after use and cleaning should approximate the clean water flux.
Trending the water flux helps to evaluate the cleaning status of the system.
Cleaning optimization should be considered:
t If the permeate flux rate is below 70% of the clean water flux.
t If the permeate flux rate decreases from run to run.
In case of further questions please contact our Sartorius Stedim application specialist.
2.6 Thermal Sterilization of
Filter Cassettes  Check steamability with ”Specifications“.
During in-line steam sterilization the entire system, including stainless steel
piping and cassette filter holder, will attain > 121°C. Exercise due caution when
working around hot equipment.
Please note that steaming in place (SIP), due to high thermal and mechanical
stress, may impact the physical properties of a membrane in terms of flow
performance and rejection. Therefore multiple use is limited.
During in-line steam sterilization, hot steam exits from the feed inlet and the
permeate outlets. Keep a safe distance away from these outlets.
Before thermal sterilization, exchange the operating torque nuts to the torque
nuts for pressure compensation.
This special compensation tool is designed to maintain constant clamp force during
thermal sterilization. If the pressure compensation tool is not used, the torque will
increase beyond the maximum allowable value as temperature increases. This may
cause irreversible damage to the filter cassettes.
Thermal sterilization should only be performed on clean filter cassettes.
Contaminants will be irreversibly fixed by thermal sterilization.
The Stabilizing pressure inlet air should be sterile filtered.

Make sure that the steam you will be using is of pharmaceutical quality, free of
rust and other particles and does not contain any hydrazine.
Prior to thermal sterilization check the filter cassettes for residual traces of
chlorine or disulfide. To denature chlorine, flush with 1% sodium thiosulfate
solution followed by flushing with purified water.
Handling safety is increased if you attach thermal condensate run-off valves to
the retentate outlet and to the permeate outlets.
2.6.1 In-Line Steam Sterilization of
Sartocon® Microfilter Cassettes
1. Assemble system as shown on the diagram.
2. Open V2, V3, V4 and V1, close V5.
3. Install cassettes into filter holder.
4. Attach a RO water source to the feed line.
5. Rinse cassette with RO water for 5 minutes at an inlet pressure of
29 psi|2 bar|200 kPa and retentate pressure of 7 psi|0.5 bar|50 kPa. Adjust valve
settings to achieve pressure values if needed.
6. Drain the system.
7. Close valve V2. Connect V2 at the retentate line with a steam generator.
16 In-Line Steam Sterilization
Stabilizing pressure inlet
Cassette
Permeate
Permeate
Feed Line
V2
V5
P
P2
P3 P1
P4
V1
V4
V3
Steam
generator
Diagram of the system for in-line steam sterilization of Microfilter cassettes.
V1–V5: valves; P1–P4: pressure gauge, P: pump

In-Line Steam Sterilization 17
8. Exchange the normal operation torque nuts to the pressure compensating torque
nuts. For specific information related to the filter holder see user manual of the
installed filter holder.
9. Use a torque wrench to tighten the pressure compensation nut to the first
notch (see picture).
10. Close valve V3 and V4 on the permeate outlets as well as V5.
11. Adjust the steam generator pressure to 14.5 psi|1.0 bar|100 kPa, and slowly open
valve V2 to initiate steam flow in to the system.
12. We highly recommend the installation of condensate run off valves.
The following step has to be incorporated if no condensate run off valves
are used. Reduce V1 valve setting on the feed line to allow a small amount
of steam to exit the system. Slowly start to increase pressure build up to
14.5 psi|1.0 bar|100 kPa by closing V1. A small amount of steam has to remain
exiting the system, which means V1 will not be closed completely.
The rentate pressure must not exceed 14.5 psi|1.0 bar|100 kPa at 121°C.
If inline pressure gauges are used, please consider that high temperatures may
cause the display to be inaccurate. Usually the actual pressure is lower than
indicated. Make sure the pressure is correctly monitored during your validation
procedure.
13. We highly recommend the installation of condensate run off valves.
The following step has to be incorporated if no condensate run off valves are
used. Once the feed pressure P1 has reached 14.5 psi|1.0 bar|100 kPa slowly
start to open the permeate valves V3|V4. A small amount of steam has to escape
from each valve.
14. Once the permeate pressure has reached 14.5 psi|1.0 bar|100 kPa the actual
sterilization begins.
15. After 30 minutes, sterilization is completed. Close valves V3|V4.
16. Close valve V1 on the feed line, V2 on the retentate line. Open V5 to apply sterile
filtered stabilizing pressure of 14.5 psi|1.0 bar|100 kPa. At this point, shut off the
steam supply.
17. Allow the holding device to cool down for 90 minutes. During cool down V5 has
to remain open.
18. After 90 minutes cool down time close V5.
19. Vent system through upper permeate valve V3. Do not open V3 completely.
Only vent excess pressure. If sterile air venting is required, please implement
a sterilizing air filter.
first notch (steaming position)
second notch (processing position)
Pressure compensating
torque nuts

20. Using a torque wrench, alternately retighten the stainless steel pressure
compensating nuts to the torque indicated below:
Clamp Force for Sartocon® Cassettes
For detailed information see Page 9
Holding Device Clamp Force
Sartocon® Slice 25 Nm Polyethersulfone
20 Nm Hydrosart®
Sartocon® 2 plus 80 Nm Polyethersulfone
60 Nm Hydrosart®
SARTOFLOW® 10 and 20 For details see instruction manual.
21. After steam sterilization is completed flush filter cassettes with RO water until
system has reached room temperature, this will also ensure that the membranes
will not dry out.
2.6.2 In-Line Steam Sterilization of Ultrafilter cassettes are sterilized through the retentate and the permeate flowpaths
Sartocon® Ultrafilter Cassettes simultaneously to maintain equal pressure within the cassette.
18 In-Line Steam Sterilization
Stabilizing pressure inlet
Cassette
Permeate
Permeate
Feed Line
V2
V5
P
P2
P3
P1
P4
V1
V4
V3
Steam
generator
Diagram of the crossflow system for in-line steam sterilization of polyethersulfone Ultrafilter cassettes.
V1–V6: valves; P1–P4: pressure gauge, P: pump
V6
Retentate Line

In-Line Steam Sterilization 19
1. Assemble system as shown on the diagramm.
2. Open V2, V3, V4, V6 and V1, close V5.
3. Install cassettes into filter holder.
4. Attach a RO water source to the feed line.
5. Rinse cassette with RO water for 5 minutes at an inlet pressure of 29 psi|2 bar|
200 kPa and retentate pressure of 7 psi|0.5 bar|50 kPa. Adjust valve settings to
achieve pressure values if needed.
6. Drain the system.
7. Close valve V2. Connect V2 at the retentate line with a steam generator.
8. Exchange torque the normal operation nuts to the pressure compensating torque
nuts. For specific information related to the filter holder see user manual of the
installed filter holder.
9. Use a torque wrench to tighten the compensation nut to the first notch
(see picture).
10. Open the connection between the retentate and permeate V6.
11. Close Valve V3 and V4 on the permeate outlets as well as V5.
12. Adjust the steam generator pressure to 14.5 psi|1.0 bar|100 kPa, and slowly open
Valve V2 to initiate steam flow in to the system.
13. We highly recommend the use of condensate run off valves. The following step
has to be incorporated in case no condensate run off valves are used. Reduce V1
valve setting on the feed line to allow a small amount of steam to exit the
system. Slowly start to increase pressure build up to 14.5 psi|1.0 bar|100 kPa by
partially closing V1. A small amount of steam has to remain exiting the system,
which means V1 will not be closed completely.
The rentate pressure must not exceed 14.5 psi|1.0 bar|100 kPa at 121°C.
If inline pressure gauges are used, please consider that high temperatures
may cause the display to be inaccurate. Usually the actual pressure is lower than
indicated. Make sure the pressure is correctly monitored.

14. We highly recommend the installation of condensate run off valves.
The following step has to be incorporated in case that no condensate run off
valves are used. Once the feed pressure P1 has reached 14.5 psi|1.0 bar|100 kPa
slowly start to open the permeate valves V3|V4. A small amount of steam has to
escape from each valve.
15. Once the permeate pressure has reached 14.5 psi|1.0 bar|100 kPa the actual
sterilization begins.
16. After 30 minutes, sterilization is completed. Close valves V3|V4.
17. Close valve V1 on the feed line, V2 on the retentate line. Open V5 to apply sterile
filtered stabilizing pressure of 1 bar. At this point, shut off the steam supply.
18. Allow the holding device to cool down for 90 minutes. During cool down V5 has
to remain open.
19. After 90 minutes cool down time close V5.
20. Vent system through upper permeate valve V3. Do not open V3 completely
only vent excess pressure. If sterile air venting is required, please implement
a sterilizing air filter.
21. Using a torque wrench, alternately retighten the stainless steel pressure
compensating nuts to the torque indicated below:
Clamp Force for Sartocon® Cassettes
Holding Device Clamp Force
Sartocon® Slice and Slice 200 25 Nm Polyethersulfone
20 Nm Hydrosart®
Sartocon® 2 plus 80 Nm Polyethersulfone
60 Nm Hydrosart®
SARTOFLOW® 10 and 20 For details see instruction manual.
22. After steam sterilization flush filter cassettes with RO water until system
has reached room temperature, this will also ensure that the membranes will
not dry out.
20 In-Line Steam Sterilization
First notch (steaming position)
Second notch (processing position)
Pressure compensating
torque nuts