Sartorius stedim Sartocube User manual

85037-550-97 Vers. 07|2015
User Manual | Bedienungsanleitung
Sartocube®|Sartocon®|Sartocon®Slice|
Sartocon®Slice 200 Cassettes
White Silicone | Weißes Silikon

English page 3
Deutsch Seite 46
2Contents

3
Contents
Contents
1. About this Document .............................................................4
1.1 Accompanying Documents...................................................6
1.2 Symbols Used.................................................................7
2. Shelf Life of unused Filtration Units.............................................8
3. Safety Instructions ................................................................9
4. Components of a Crossflow System ............................................ 14
5. Start up of cassettes ............................................................ 16
5.1 Installing Filter Cassettes in a Holding Device.............................. 16
5.2 Clamping Forces ............................................................ 17
5.3 Rinsing Cassettes ........................................................... 19
5.4 Integrity Test ............................................................... 20
5.4.1 Manual Integrity Test .............................................. 20
5.4.2 Automatic Integrity Test (Pressure Decay) ......................... 21
5.5 Determining Clean Water Flux for Filter Cassettes (CWF) .................. 22
5.6 Thermal Sterilization of Filter Cassettes.................................... 24
5.6.1 In-Line Steam Sterilization of Sartocon®Microfilter Cassettes .... 25
5.6.2 In-Line Steam Sterilization of Sartocon®Ultrafilter Cassettes..... 29
5.6.3 Autoclaving the Filter Cassette .................................... 32
5.7 Filtration.................................................................... 34
5.8 Cassette Cleaning........................................................... 35
5.9 Cassette Disinfection ....................................................... 38
5.10 Cassette Storage............................................................ 39
5.10.1 Short Term Storage ................................................ 39
5.10.2 Long Term Storage ................................................. 40
5.11 Cassette Return Instructions ............................................... 41
5.12 Disposal (Status: May 2009)................................................ 41
6. Technical Data................................................................... 42
6.1 Technical Specifications Sartocon®Slice 200............................... 42
6.2 Technical Specifications Sartocon®Slice ................................... 43
6.3 Technical Specifications Sartocon®......................................... 44
6.4 Technical Specifications Sartocube®........................................ 45

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.

5
About this Document
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.

6About this Document
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
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.

7
About this Document
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.

8Shelf 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.

9
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 17, 18].
Torquing the filter cassettes too tightly will damage
them.
The maximum inlet pressure must not be exceeded
[ÆChapter “6. Technical Data”, page 42–45].
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 compensa-
tion 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.

10 Safety Instructions
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 damag-
ing 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 technolog-
ically possible.
The effective torque on hydraulic holding devices
should be kept constant, especially when the hold-
ing device is installed in a large filtration system.
The maximum allowable back pressure on the per-
meate 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.

11
Safety 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 exam-
ple, 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.

12 Safety Instructions
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. Otherwise, the flux
rate of the filter cassettes will decrease rapidly
during filtration under static conditions (dead-end-
ed filtration) [ÆChapter “5.7 Filtration”,
page 34].
Sartocon®Slice 200 Cassette Sartocon®Slice Cassette
Sartocon®Cassette Sartocube®Cassette

13
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 cross-
flow 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 manufac-
turer (e.g. gaskets, tubing or hoses).

14 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

15
Components of a Crossflow System
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

16 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 17, 18].
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

17
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*
Required
compression
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…
14–17 kN 20 Nm 17 Nm t.b.d.
Sartocon®
Slice 200 and
Sartocon®Slice
PESU UF
308146…
305154...
18–21 kN 25 Nm 17 Nm t.b.d.
Sartocon®
Slice 200 and
Sartocon®Slice
PESU Max
308146AL…
305146AL…
14–17 kN 25 Nm 25 Nm No thermal
sterilization
Sartocon®
Slice 200 and
Sartocon®Slice
Hydrosart®MF
308186…
305144…
14–17 kN 20 Nm 25 Nm t.b.d.
Sartocon®
Slice 200 and
Sartocon®Slice
PESU MF
308154…
305146…
18–21 kN 25 Nm 17 Nm t.b.d.
* List of sterilizable cassettes is available in “Technical Specifications”, section 6.1.

18 Start up of cassettes
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
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.

19
Start up of cassettes
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 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 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.

20 Start up of cassettes
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.
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 42–45], 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