Sartorius Virosart HF 3VI 28 Serie Gebrauchsanleitung

Instructions for Use
Virosart HF 3VI--28-... Process Modules
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1. Summary
The purpose of this document is to provide the
appropriate method for identifying, installing and using
Sartorius Stedim Biotech Virosart
The procedure should be strictly followed to ensure
operator safety and to maintain optimum performance
of Virosart HF filter elements.
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This document pertains to Sartorius Stedim Biotech
Virosart HF filter elements with the following part
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numbers:
3VI--28-HCGSF
(Virosart HF process module 0.8 m²)
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3VI--28-MCGSF
(Virosart HF process module 2.4 m²)
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All Virosart HF process modules have sanitary
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inlet & outlet connections.
2. Labeling of Virosart HF Process Modules
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The type, order code, lot number and serial number
are imprinted on the outer support of the housing of
the Virosart HF process module. In addition these
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specifications are printed on the labels of the plastic
bag and the cardboard box. The direction of venting is
indicated by an arrow on the module as well as all inlet,
venting and outlet connections are labeled with the
respective purpose.
3. Installation of Virosart
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In a validated production step Virosart
Process Modules are sterilized by gamma irradia­
tion according to EN ISO 11137. Sterility, however,
is only guaranteed when this primary packaging
is intact before using the Virosart
Modules as a sterile product. If the packaging is
damaged in any way the Virosart
Modules cannot be handled as a sterile product.
If the Virosart HF process module is to be used as
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a sterile product, care must be taken to prevent conta-
mination when connecting the module to the filtration
system. Virosart HF process modules are connected
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to the processing line at the inlet and outlet via triclamp
(please do not forget the gaskets!) connections. To
ensure appropriate wetting a pressure indicator at
inlet and outlet connection should be used as well as
a pressure regulator (e.g. diaphragm valve) at the out-
let connection (see picture below). It is recommended
to connect a valve (e.g. diaphragm valve) followed by
a venting filter (e.g. Sartofluor
to the vent connection via triclamp.
Typical wetting set up for Virosart
4. Wetting Virosart HF Process Modules
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(In the direction of filtration)
Before every integrity test or operation, the entire
system needs to be rinsed to ensure that it is particle-
free as well as for complete wetting of the membrane
and proper use of the whole filter capacity. Incomplete
wetting might result in failed integrity testing. For
proper wetting of the membrane, back pressure is
required as indicated in paragraph 3.
To rinse the filter element, open the connected valve
at the vent connection and fill the housing with WFI.
Outlets placed upwards will ensure air elimination.
To ensure that all the air has been removed from the
lumen, keep the valve in front of the venting filter
opened during the whole flushing procedure. Start
rinsing the filter at an inlet pressure of 2.5 bar | 36 psi
against an outlet pressure of 2.0 bar | 29 psi (set by the
connected diaphragm valve). Rinse the filter element
for >20 min under these conditions to insure proper
wetting for a following pre-use integrity test.
If no pre-use integrity test will be performed, flushing
without back pressure will be sufficient for operation.
The housing can be drained by opening the outlet
valves and using compressed air or nitrogen at a maxi-
mal pressure of 0.5 bar | 7 psi in the direction of filtration.
It can also be drained by simply opening the valves,
allowing the solution to drain out by gravity flow.
Outlet valves placed downwards will ensure complete
draining. After the housing is empty, close all the valves.
After the Virosart HF has been flushed according
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to the instructions, it is thoroughly wetted.
5. Integrity Testing of Virosart
It is very important to follow the wetting procedure for
Virosart HF to make sure that the filter is wetted out
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completely prior to the integrity test. The integrity test
of a Virosart HF filter must be done using an automated
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integrity test unit, preferably the Sartocheck
test unit. Before performing an integrity test the valve
at the vent connection has to be closed to avoid air
penetration within the connected air filter. When using
a Sartorius Stedim Biotech Sartocheck
system, the diffusion test can be performed automati-
cally, recording the corresponding integrity test data.
HF process modules.
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HF Process Modules
HF
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HF Process
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HF Process
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0,2 µm, 5185307T7--SS)
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HF filter elements
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HF Process Modules
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integrity
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integrity test
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The test pressure for diffusion testing is 4.5 bar |
65.25 psi with a stabilization as well as testing time of
5 min. Certain applications (e.g. single-use transfer
sets) may require a reduced test pressure. In this case
diffusion testing can be executed at 2.5 bar | 36.3 psi
with a stabilization as well as testing time of 5 min. For
additional information on how to perform an automatic
integrity test please see our installation and operating
instructions for the Sartocheck
Integrity Test Data for Virosart
Integrity test Filter type
Water based 3VI--28-HCGSF 2.5 bar |
Diffusion test
Water based 3VI--28-HCGSF 4.5 bar |
Diffusion test
Water based 3VI--28-MCGSF 2.5 bar |
Diffusion test
Water based 3VI--28-MCGSF 4.5 bar |
Diffusion test
Remark
All values given above were obtained at room tempera-
ture and using water as wetting agent.
6. Maximal Allowable Differential Pressure
Virosart HF process modules
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In the direction of filtration
In the reversed direction of
filtration
7. Filtration with Virosart
Virus filtration with Virosart
the end of the purification process prior to the last
buffer exchange | form and fill. The protein solution
which is subject to the virus filtration must be free of
aggregates, host cell protein & DNA to avoid prema-
ture blockage of Virosart
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nants should be removed either during the initial
recovery process or latest during the polishing process
of the target molecule, small amounts might be
sufficient to cause premature blockage of the final
virus filter. To prevent this, an efficient pre-filtration
step, such as the Virosart
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protection for the Virosart
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to final filter ratio has to be identified during develop-
ment of this process step. To make full use of the filtra-
tion area, the lumen must be vented completely free
of air. To do this, keep the valve connected to the vent
filter open during the whole operation. Then apply the
desired filtration pressure. The pre-filter should be
used in-line with the final virus filter under the same
conditions. The Virosart HF can be operated at any
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pressure from 1 bar up to 5 bar. The filter qualification
was performed at an operating pressure of 2 bar | 29 psi
to meet customer standard requirements. The flow rate
achieved through the Virosart
is a function of the purity of the feed stream, the target
molecule size and concentration. The flow rate might
decline with the progress of filtration and indicate the
respective blockage of the filter. After filtration the
Virosart HF module can be flushed to maximize pro-
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tein transmission. Therefore please flush the module
with 10 L/m² of buffer.
8. Changing out the Virosart
The Virosart HF process module must be changed,
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at the latest, when the maximum allowable differential
pressure is reached or when the validated process
volume has been processed over the filter.
9. Applications Support
If required, please contact your local Sartorius Stedim
Biotech representative to obtain further information
on technical data, product integrity testing or general
information concerning specific applications. Our
application specialists from Purification Technologies
will gladly assist in your filtration trial work if needed.
Moreover our validation service and support team are
always available to assist in questions concerning
product and process validation, as well as training of
staff and optimization of filtration processes.
10. Return of used filter elements
If you wish to return used filter elements to Sartorius
Stedim Biotech for inspection, it is necessary to
decontaminate and sterilize them prior to shipment.
This procedure has to be documented in the return
shipment form, available from your local Sartorius
Stedim Biotech representative. This documentation
is required by country law. Returned filter elements
cannot be handled unless the appropriate return
shipment form is completed.
11. Liability
Sartorius Stedim Biotech cannot assume liability if
Virosart HF filter elements are subject to improper
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use. In the interest of product development we reserve
the right to make changes.
Thank you for working with Sartorius Stedim Biotech,
we appreciate your business.
85037-540-65
85037-540-65
integrity test unit.
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HF Process Modules
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Test Limit
pressure
11 ml/min
36.3 psi
20 ml/min
65.25 psi
33 ml/min
36.3 psi
60 ml/min
65.25 psi
At 20°C max. 5.0 bar |
73 psi
At 20°C max. 2.5 bar |
36.3 psi
HF
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HF should be realized at
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HF. Even if these contami-
Max, might be required as
HF. The optimum pre-filter
HF during the filtration
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HF process modules
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