Sartorius Stedim Biotech Sartocube User manual

User Manual | Bedienungsanleitung
Sartocube®|Sartocon®|Sartocon®Slice|
Sartocon®Slice 200 Cassettes
White Silicone | Weißes Silikon
1000035949 Vers. 11 | 2018

2Contents
English page 3
Deutsch Seite 31

3
Contents
Contents
1. About this Document .............................................................4
1.1 Accompanying Documents...................................................5
1.2 Symbols Used.................................................................5
2. Shelf Life of unused Filtration Units.............................................6
3. Safety Instructions ................................................................7
4. Components of a Crossflow System ............................................ 10
5. Start up of cassettes ............................................................ 11
5.1 Installing Filter Cassettes in a Holding Device.............................. 11
5.2 Clamping Forces ............................................................ 12
5.3 Rinsing Cassettes ........................................................... 13
5.4 Integrity Test ............................................................... 13
5.4.1 Manual Integrity Test .............................................. 14
5.4.2 Automatic Integrity Test (Pressure Decay) ......................... 14
5.5 Determining Clean Water Flux for Filter Cassettes (CWF) .................. 15
5.6 Thermal Sterilization of Filter Cassettes.................................... 16
5.6.1 In-Line Steam Sterilization of Sartocon®Microfilter Cassettes .... 16
5.6.2 In-Line Steam Sterilization of Sartocon®Ultrafilter Cassettes..... 18
5.6.3 Autoclaving the Filter Cassette .................................... 20
5.7 Filtration.................................................................... 21
5.8 Cassette Cleaning........................................................... 22
5.9 Cassette Storage............................................................ 24
5.9.1 Short Term Storage ................................................ 24
5.9.2 Long Term Storage ................................................. 24
5.10 Cassette Return Instructions ............................................... 25
5.11 Disposal..................................................................... 25
6. Technical Data................................................................... 26
6.1 Technical Specifications Sartocon®Slice 200............................... 26
6.2 Technical Specifications Sartocon®Slice ................................... 27
6.3 Technical Specifications Sartocon®......................................... 28
6.4 Technical Specifications Sartocube®........................................ 29

4About this Document
1. About this Document
This user manual provides you with all the information necessary to install
the Sartocube®, Sartocon®, Sartocon®Slice and Sartocon®Slice 200 Cassettes.
These cassettes will also hereinafter be referred to as product or cassette.
− The user manual informs you about how to operate the product according
to the safety requirements.
The user manual must be read, understood and used by all persons entrusted with the
installation and use of the product. This applies particularly to the safety instructions
listed.
− Please read this user manual carefully and completely before working with
the cassette.
− This user manual is part of the product. Keep it in a safe and easily accessible place
near the device's site of installation.
− If the manual should be lost or misplaced, please contact Sartorius for a
replacement or download the latest version from our website: www.sartorius.com
In addition to the user manual, all generally valid, legal and otherwise binding
regulations for accident protection and environmental protection of the country of
use must be observed.
This user manual must always be kept at the place of use of the cassette.
− Any guarantees and warranties shall apply to manufacturing-related defects and
malfunctions.
− The device is designed for standard laboratory conditions and techniques.
This user manual describes the product at the time of printing stated in the revision
number.
All data has been compiled with care, although no guarantee can be given for the
data provided. Sartorius Stedim Biotech GmbH reserves the right to make technical
changes to the design and equipment of its products or to make changes to the
associated documentation without any prior notice or specific mention.
Because Sartorius' products are constantly undergoing further development, some
components and their operation may not be described in this manual.
This manual may also contain information that does not apply to setup. Please notify
us if any information is missing that is important to you, if you find any errors in the
content or require more extensive information on specific components.
If you have any questions about our product program or the use of the cassette
which are not dealt with in this manual, please contact:
Sartorius Stedim Biotech GmbH
Crossflow Business Unit
August-Spindler-Strasse 11
37079 Goettingen, Germany
Phone [phone]
Fax +49.551.308.289
[email protected]
www.sartorius-stedim.com

5
About this Document
1.1 Accompanying Documents
This user manual describes how to install the product along with the standard
equipment intended for this purpose.
In addition to these instructions, please observe the user manual for the filter holder.
1.2 Symbols Used
As a means of instruction and direct warning against hazards, all text statements to
be particularly noted in this user manual will be marked as follows:
This instruction denotes a possible danger with medium risk that death or severe
injury may result if it is not avoided.
This symbol denotes a possible danger with risk that moderate or minor injury
may result if it is not avoided.
This symbol denotes a danger with the low risk
that could result in property damage if the risk is not avoided.
This symbol indicates that the preservative is not suitable for consumption.
This symbol
− is an indication of a function or setting on the device.
− that caution should be exercised while working.
− identifies useful information.
The following presentations will also be used:
–Texts that follow this mark are lists.
tTexts that follow this mark describe activities that must be carried out
in the specified order.
yTexts that follow this mark describe the result of an action.
“ ” Texts in quotes are references to other chapters or sections.
[Æ]Texts following this symbol make reference to other chapters, sections
or documents.

6Shelf Life of unused Filtration Units
2. Shelf Life of unused Filtration Units
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.

7
Safety Instructions
3. Safety Instructions
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 [ÆChapter “5.2 Clamping Forces”,
page 12]. Torquing the filter cassettes too tightly will damage them.
The maximum inlet pressure must not be exceeded
[ÆChapter “6. Technical Data”, page 26].
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 compensating 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
compatibility before beginning a filtration run in order to avoid damaging the
membranes. 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, espe-
cially 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.

8Safety Instructions
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 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 cas-
settes, please contact our application specialist.
Make sure that the correct crossflow conditions are maintained during
filtration. Otherwise, the flux rate of the filter cassettes will decrease rapidly
during filtration under static conditions (dead-ended filtration) [ÆChapter “5.7
Filtration”, page 21].
Sartocon®Slice 200
Cassette
Sartocon®Slice Cassette Sartocon®Cassette Sartocube®Cassette

9
Safety Instructions
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 “Technical Specifications,” the pressure resistance
of the crossflow system will decrease.
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).

10 Components of a Crossflow System
4. Components of a Crossflow System
Holding Device
Sartocon®Slice 200
(Holder for max. 2 Slice 200
Cassettes)
Mat. No. #17525---01
Sartocon®Slice
(for 1-3 Slice Cassette Holder)
Mat. No. #17521---001
Need for No. #: 1ZLI-V0001
additional longspacers to run
a Slice 200 cassette
Sartocon®Slice
(for 1-5 Slice Cassette Holder
[Sartoflow®Alpha])
Mat. No. #17521---002
Sartocon®2 plus
1–10 Cassettes
[Order Nr.: 17546*]
Sartoflow®10 Holder
1–10 Cassettes
Sartoflow®20 Holder
2–20 Cassettes

11
Start up of cassettes
5. Start up of cassettes
5.1 Installing Filter Cassettes in a Holding Device
To install the cassettes in a Sartorius Stedim Biotech holding device, proceed as
follows:
t Remove filter cassette from its packaging.
t Check and record cassette labelling.
t Place the filter cassette with the semi-circular cutouts facing downward on the
two guide rods between the two holding plates.
t Alternately tighten the compression nuts until the filter cassette(s) is (are) secured
in place by the holding plates.
t Use a torque wrench to tighten the copression nuts alternately to the torque
specified. Please see [ÆChapter “5.2 Clamping Forces”, page 12,].
t 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 and take special care to avoid
contaminating them with grease! If the threading becomes contaminated with
grease or dirt, the tensioning forces will be affected and the cassettes may be
destoyed.
Sartocon®2 plus
[Order Nr.: 17546*]
Pressure compensating torque nuts
Semi-circular cutouts
Guide rods

12 Start up of cassettes
5.2 Clamping Forces
Sartocon®Slice 200 and Sartocon®Slice Holding Device, Manual closure
Cassette type Order
number Previous Slice holder
and Slice 200
holder
New Slice 200
and Slice
holder with
trapezoidal
thread,
PEEK washer
and bronze nut
(available since
July 2014**)
Sterilization*
Torque applied
with a torque
wrench
Torque
applied
with a
torque
wrench
Torque
applied
with a
torque
wrench
Sartocon®
Slice 200 and
Sartocon®Slice
Hydrosart®UF
308144…
305186…
20 Nm 17 Nm t.b.d.
Sartocon®
Slice 200 and
Sartocon®Slice
PESU UF
308146…
305154...
25 Nm 17 Nm t.b.d.
Sartocon®
Slice 200 and
Sartocon®Slice
PESU Max
308146AL…
305146AL…
25 Nm 25 Nm No thermal
sterilization
Sartocon®
Slice 200 and
Sartocon®Slice
Hydrosart®MF
308186…
305144…
20 Nm 25 Nm t.b.d.
Sartocon®
Slice 200 and
Sartocon®Slice
PESU MF
308154…
305146…
25 Nm 17 Nm t.b.d.
* List of sterilizable cassettes is available in “Technical Specifications”, section 6.1.
Sartocon®2 plus Holding Device, Manual closure
Cassette type Order
number Required Compression Sterilization* Torque applied
on Tie Rods
with a
Torque
Wrench
Sterilization*
Operating Conditions Operating Conditions
Sartocube®and
Sartocon®
Cassettes
302146...|
302154…
18–35 kN < 10 kN 80 Nm first notch
PESUmax 302146AL…21–35 kN No thermal
sterilization
80 Nm No thermal
sterilization
Sartocube®and
Sartocon®
Hydrosart®MF|UF
302144…|
302186…
18–25 kN < 10 kN 60 Nm first notch

13
Start up of cassettes
Sartoflow®10 | Sartoflow®20 and Sartoflow®Systems
with Hydraulic Piston, 12.5 cm2
Cassette type Order
number Required Compression Sterilization* Hydraulic Pressure
Sterilization*
Operating Conditions Operating Conditions
Sartocube®and
Sartocon®
Cassettes
302146...|
302154…
18–35 kN < 10 kN 170 bar
(2466 PSI)
(17 MPa)
80 bar
(1160 PSI)
(8 MPa)
PESUmax 302146AL…21–35 kN No thermal
sterilization
170 bar
(2466 PSI)
(17 MPa)
No thermal
sterilization
Sartocube®and
Sartocon®
Hydrosart®MF|UF
302144…|
302186…
18–25 kN < 10 kN 170 bar
(2466 PSI)
(17 MPa)
80 bar
(1160 PSI)
(8 MPa)
* List of sterilizable cassettes is available in “Technical Specifications”, section 6.1.
** After every tenth time of use, the PEEK washers should be replaced. The bronze nut or
the trapezoidal thread should be replaced as soon as abrasion is visible. It is essential that
the bronze nut and the trapezoidal thread are kept clean.
5.3 Rinsing Cassettes
Flush the filter cassettes as indicated below:
− Before initial use with purified water
− With buffer or physiological saline before filtration
− With buffer or physiological saline before cleaning
− With purified water after cleaning
− With purified water after disinfection
− With purified water before checking the functionality of the filter cassettes
− With purified water before sterilization
Flush Procedure for Cassettes
The installed cassettes must be flushed with purified water or RO water at the recom-
mended 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 Approx. 1 : 1
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 m2filter area.
5.4 Integrity Test
For multiple cassette integrity testing see ”#1 Technical Data Package Integrity testing
Sartocon®Cassettes“.
The Technical Data Package Integrity testing is available upon request from your local
application specialists.
Ensure the filter cassettes are sufficiently wet before measuring the air diffusion.

14 Start up of cassettes
5.4.1 Manual Integrity Test
Proceed as follows:
t Attach a hose to the feed inlet (V1), and connect the other end of the hose to a
compressed air source.
t Close the retentate outlet (V2).
t Adjust the inlet test pressure pinlet to the value specified [ÆChapter “6. Technical
Data”, page 26], and keep this pressure constant.
t Close the lower permeate outlet valve V3.
t At a constant inlet pressure pfeed, wait four minutes until the system has stabilized.
t Use a flow meter or an inverted burette filled with water to measure the air
diffusion at the upper permeate outlet.
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
5.4.2 Automatic Integrity Test (Pressure Decay)
Proceed as follows:
t Connect the integrity tester [such as Sartocheck®3 plus (16290) or S
artocheck®4 Plus (26288)] to the power supply and pressure source.
t Close the retentate outlet (V2) and open the permeate outlets (V3, V4).
Open V5and close V1.
t Enter the required test parameter according to the Sartocheck®instruction manual
and cassette data.
t Use the following parameter:
stab. time: 4 min.
test time: 2 min.
t Enter the maximum allowable diffusion value [ÆChapter “6. Technical Data”,
page 26].
t Start the Integrity Test.
Sartocheck®
Retentate outlet
closed
V5
V2
Pump V1V4
V3
Feed inlet
closed
Permeate open
Permeate open
Cassette
P1
P2
P3
Fig. 2: System set up for automatic integrity testing. V1–V5: valves; P1–P3: pressure gauge.
If the hold up volume exceeds 9 l, please contact your Sartorius Stedim application
specialist.

15
Start up of cassettes
5.5 Determining Clean Water Flux for Filter Cassettes (CWF)
The water flux test is an easy and non-destructive test that measures the ability 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:
t Rinse new installed cassettes to remove preservatives.
t Post use sanitization cassettes with 1 N Sodium hydroxide and neutralize.
t Run the clean water flux with purified water as specified in the table below.
t Measure retentate rate and permeate rate at constant temperature (20°C).
t 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-
mentioned 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
valve open
[psi|bar|kPa]
Retentate
Pressure
[psi|bar|kPa]
Permeate Pressure
valve open
[psi|bar|kPa]
Sartocon®Slice
Cassette and
Slice 200
29|2|200 7|0.5|50 0|0|0
Sartocon®Cassette 29|2|200 7|0.5|50 0|0|0
Multiple Sartocon®
Cassettes
29|2|200 10–14|0.7–1|70–100 <7|0.5|50
Sartocube®Cassette 29|2|200 10–14|0.7–1|70–100 <7|0.5|50
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:
− If the permeate flux rate is below 70% of the clean water flux.
− If the permeate flux rate decreases from run to run.
In case of further questions please contact our Sartorius Stedim application specialist.

16 Start up of cassettes
5.6 Thermal Sterilization of Filter Cassettes
Check steamability with ”Specifications“[ÆChapter “6. Technical Data”,
page 26].
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.
5.6.1 In-Line Steam Sterilization of Sartocon®Microfilter Cassettes
Stabilizing pressure inlet
Cassette
Permeate
Permeate
Feed Line
V2
V5
P
P2
P3 P1
P4
V1
V4
V3
Steam
generator
Fig. 3: Diagram of the system for in-line steam sterilization of
Microfilter cassettes. V1–V5: valves; P1–P4: pressure gauge, P: pump

17
Start up of cassettes
t Assemble system as shown on the diagram.
t Open V2, V3, V4and V1, close V5.
t Install cassettes into filter holder.
t Attach a RO water source to the feed line.
t 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.
t Drain the system.
t Close valve V2. Connect V2at the retentate line with a steam generator.
t 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.
t Use a torque wrench to tighten the pressure compensation nut to the first notch
(see picture).
t Close valve V3and V4on the permeate outlets as well as V5.
t Adjust the steam generator pressure to 14.5 psi|1.0 bar|100 kPa, and slowly open
valve V2to initiate steam flow in to the system.
t 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 V1will
not be closed completely.
The feed 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.
Pressure compensating torque nuts
First notch
(steaming position)
Second notch
(processing position)
t 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 P1has 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.
t Once the permeate pressure has reached 14.5 psi|1.0 bar|100 kPa the actual
sterilization begins.

18 Start up of cassettes
t After 30 minutes, sterilization is completed. Close valves V3|V4.
t Close valve V1on the feed line, V2on the retentate line. Open V5to apply sterile
filtered stabilizing pressure of 14.5 psi|1.0 bar|100 kPa. At this point, shut off the
steam supply.
t Allow the holding device to cool down for 90 minutes. During cool down V5has to
remain open.
t After 90 minutes cool down time close V5.
t Vent system through upper permeate valve V3. Do not open V3completely. Only
vent excess pressure. If sterile air venting is required, please implement
a sterilizing air filter.
t Using a torque wrench, alternately retighten the stainless steel pressure compen-
sating nuts to the torque indicated [ÆChapter “5.2 Clamping Forces”, page 12].
t 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.
5.6.2 In-Line Steam Sterilization of Sartocon®Ultrafilter Cassettes
Ultrafilter cassettes are sterilized through the retentate and the permeate flowpaths
simultaneously to maintain equal pressure within the cassette.
Stabilizing pressure inlet
Cassette
Permeate
Permeate
Feed Line
V2
V5
P
P2
P3
P1
P4
V1
V4
V3
Steam
generator
V6
Retentate Line
Diagram of the crossflow system for in-line steam sterilization
of polyethersulfone Ultrafilter cassettes.
V1–V6: valves; P1–P4: pressure gauge, P: pump
t Assemble system as shown on the diagramm.
t Open V2, V3, V4, V6and V1, close V5.
t Install cassettes into filter holder.
t Attach a RO water source to the feed line.
t 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.
t Drain the system.
t Close valve V2. Connect V2at the retentate line with a steam generator.
t 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.
t Use a torque wrench to tighten the compensation nut to the first notch

19Start up of cassettes
(see picture).
t Open the connection between the retentate and permeate V6.
t Close Valve V3and V4on the permeate outlets as well as V5.
t Adjust the steam generator pressure to 14.5 psi|1.0 bar|100 kPa, and slowly open
Valve V2to initiate steam flow in to the system.
t 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 V1valve
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
V1will not be closed completely.
The feed 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.
t 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 P1has 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.
Pressure compensating torque nuts
First notch
(steaming position)
Second notch
(processing position)
t Once the permeate pressure has reached 14.5 psi|1.0 bar|100 kPa the actual
sterilization begins.
t After 30 minutes, sterilization is completed. Close valves V3|V4.
t Close valve V1on the feed line, V2on the retentate line. Open V5to apply sterile
filtered stabilizing
pressure of 1 bar. At this point, shut off the steam supply.
t Allow the holding device to cool down for 90 minutes. During cool down V5has to
remain open.
t After 90 minutes cool down time close V5.

20 Start up of cassettes
t Vent system through upper permeate valve V3. Do not open V3completely only
vent excess pressure. If sterile air venting is required, please implement a sterilizing
air filter.
t Using a torque wrench, alternately retighten the stainless steel pressure compen-
sating nuts to the torque indicated [ÆChapter “5.2 Clamping Forces”, page 12].
t 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.
5.6.3 Autoclaving the Filter Cassette
t Tighten the filter cassettes along with the pressure compensation nuts of the hold-
ing device.
t Flush the filter cassettes with purified water as described under ”Rinsing Cassettes“
section 2.3.
t Use the torque wrench to tighten the pressure compensation nuts alternately up
to the first notch (autoclaving position).
t Connect a hose to each connection of the holding device.
t Place the holding device in the autoclave.
t Fill the hoses with purified water. Immerse all hose ends in a container filled with
5 l of purified water. Place this container in the autoclave as well. This will prevent
the filter cassettes from drying out during autoclaving.
t Start the autoclave. To avoid damage of the filter cassette, autoclave the system
without final vacuum.
t Autoclave the holding device and filter cassettes for 30 min. at 121°C.
t Seal the ends of the hoses immediately after you have opened the autoclave.
For this purpose, you can use either hose clamps or valves. This will prevent
contamination and will protect the filter cassettes from drying out.
t Allow the holding device to cool off.
t Use the torque wrench to tighten the pressure compensation nuts alternately up
to the second notch [ÆChapter “Cassette Disinfection”, page 23].
Pressure compensating torque nuts
First notch
(steaming position)
Second notch
(processing position)