Sartorius Maxicaps MR Virosart HF User manual

Instructions for Use
Maxicaps®MR Virosart®HF,
Max and Media
1000063447

Instructions for Use Maxicaps®MR Virosart®HF, Max and Media 3
Contents
Contents
1 General Information .....................................................5
1.1 Intended Use ........................................................5
1.2 Language............................................................6
1.3 Labeling .............................................................6
1.4 In-Line Steam Sterilization...........................................6
1.5 Maximum Operating Pressure.......................................6
1.6 Maximum Allowable Differential Pressure ..........................7
1.7 Integrity Tests and Integrity Test Data................................8
1.8 Use in a Suitably Protected Environment............................9
1.9 Product Change .....................................................9
1.10 Application Support ................................................10
1.11 Returning Used Filter Elements ....................................10
1.12 Liability .............................................................10
2 General Product Description ............................................11
3 Parts Overview..........................................................13
3.1 Inlet Tube . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.2 Outlet Tube for Virosart®HF Filter ..................................15
3.3 Outlet Tube forVirosart®Max and Media Filter.....................16
4 General Process Description............................................17
5 Installation ..............................................................18
5.1 UnpackingandTransfertoCleanRoom ............................18
5.2 Installation Manual Actuators......................................20
5.3 Installation Air FilterVenting Line...................................21
6 Wetting & Equilibration ................................................25
6.1 Filling and Venting................................................. 25
6.2 Wetting & Equilibration for Maxicaps®MR Virosart®HF ........... 26
6.3 Wetting & Equilibration for Maxicaps®MR Virosart®Max...........27
6.4 Wetting & Equilibration for Maxicaps®MR Virosart®Media.........27

4 Instructions for Use Maxicaps®MR Virosart®HF, Max and Media
Contents
7 Filtration ................................................................29
7.1 Part I: Connection and Filtration................................... 29
7.2 PartII(optional):EmptyingwithPressureAfterFiltration .........30
7.3 Part III Disconnection...............................................31
8 Pre- & Post-Use IntegrityTest ..........................................32
8.1 Integrity Testing.....................................................33
8.2 Pressure Safety Device ............................................ 34
9 Disassembling ..........................................................35
10 Technical Data ..........................................................37
10.1 Pressure Safety Device MR ........................................40
11 Appendix................................................................42
11.1 Applications Support .............................................. 42
11.2 Liability ............................................................ 42
12 Conformity..............................................................43
12.1 EU Declaration of Conformity ......................................43

Instructions for Use Maxicaps®MR Virosart®HF, Max and Media 5
General Information
1 General Information
Following additional parts are needed (Sartorius order number) and were
send in a separate box:
−3 manual SU valve drives (3x BPR0202): re-usable
−1 pressure safety device (1x 26787---PS): re-usable
−Pre-filter: single-use
Sartopore®2 XLM Virosart®Max
Virosart®Media
(Upstream)
Virosart®HF
(Downstream)
1.1 Intended Use
Maxicaps®MR Virosart®is an integrity testable single-use filtration system for
pharmaceutical and biopharmaceutical production.
Please refer to the respective filter validation guide regarding the use of:
−Acids, Bases
−Inflammable fluids
−Oxidizing fluids
Maxicaps®MR Virosart®must be used for filtration of water based liquids only.
Maxicaps®MR Virosart®is a single-use device. The duration of usage should
not exceed 48 hours.

6 Instructions for Use Maxicaps®MR Virosart®HF, Max and Media
General Information
1.2 Language
Other languages of the instructions for Maxicaps®MR Virosart®HF, Max and
Media can be found on our website www.sartorius.com.
1.3 Labeling
The filter type, pore size or retention rate are lasered on the filter housing.
Theremaininginformationlaseredontheindividualfilterhousingsonlyrefer
to the individual filter capsules themselves and not to the complete
Maxicaps®MR Virosart®.
The label on the plastic bag, the plastic holder of Maxicaps®MR Virosart®and
the other packaging includes the product name, expiry date, gamma irradia-
tion indicator (Virosart®HF and Media only) and batch number along with the
order code.
1.4 In-Line Steam Sterilization
IMPORTANT
Maxicaps®MR Virosart®must not be in-line steam sterilized!
1.5 Maximum Operating Pressure
The maximum operating and integrity test pressure should not exceed
2.5bar|36psi.
Since the max. pressure should never be exceeded the user must install a
pressure safety device to protect the Maxicaps®MR Virosart®when used with
pressurized gas (i.e. for integrity testing). Pressure safety device available form
Sartorius (see chapter “10 Technical Data”, page 37).

Instructions for Use Maxicaps®MR Virosart®HF, Max and Media 7
General Information
Installation, connection and opening or closing only in non-pressurized
system status.
IMPORTANT
It is highly recommended to use a pressure indicator on Maxicaps®MR
Virosart®Inlet side (e.g. a Sartorius SensorTransfer Set – Data Sheet:
S--2209-e) for pressure control throughout all process steps. Further it is
highly recommended to have a flow rate indicator at the inlet side.
1.6 Maximum Allowable Differential Pressure
In the direction of filtration
− at20°Cmax.2.5bar|36psi
In the reverse direction of filtration
− at20°Cmax.1.0bar|14.5psiforMaxicaps®MR Virosart®Media
− at20°Cmax.2.5bar|36psiforMaxicaps®MR Virosart®HF
− at20°Cmax.0.5bar|7.3psiforMaxicaps®MR Virosart®Max
IMPORTANT
Filtration of gas is prohibited for Maxicaps®MR Virosart®devices. The dry
Maxicaps®MR Virosart®should not be put under gas pressure more than
1bar|14.5psi.
For integrity testing with a wetted Maxicaps®MR Virosart®, only the use of air
and nitrogen is allowed!
Please use a safety pressure device (Sartorius order code: 26787---PS) when
connected to pressurized gas.

8 Instructions for Use Maxicaps®MR Virosart®HF, Max and Media
General Information
1.7 IntegrityTests and IntegrityTest Data
After wetting, Maxicaps®MR Virosart®can be integrity tested. It is highly
recommended that testing is performed by an automatic integrity testing
device like Sartocheck®.
For the Maxicaps®MR Virosart®HFand Media the test conditons are:
Test pressure: 2.5bar|36psi
Stabilization time: 5 min
Testing time: 5 min
Alarm values for the corresponding product:
3VI--28-MCG-MR2 ≤ 41.0mL/min
3VI--28-MCG-MR3 ≤ 60.0mL/min
3VI--28-MCG-MR4 ≤ 79.0mL/min
3VI--28-MCG-MR5 ≤ 99.0mL/min
3VI--28-MCG-MR6 ≤ 117.0mL/min
3V2--28-IVG-MR3 ≤ 48.0mL/min
3V2--28-IVG-MR6 ≤ 97.0mL/min
For the Maxicaps®MR Virosart®Max the test conditons are:
Test pressure: 2.0bar|29psi
Stabilization time: 5 min
Testing time: 5 min

Instructions for Use Maxicaps®MR Virosart®HF, Max and Media 9
General Information
Alarm values for the corresponding product:
54A7358N3--MR3 ≤ 16.0mL/min
54A7358N3--MR6 ≤ 31.0mL/min
54A7358N3--MR9 ≤ 46.0mL/min
For more information about single device integrity testing and product
specific integrity test data, please refer to the respective validation guides of
the single filter elements.
External mechanical impacts (e.g. falling, hitting against table edges) to any
filter elements can cause micro-cracks that may not be visible to the naked
eye, but can lead to destruction of the respective filter element when they are
pressurized later. For this reason, filter elements may no longer be used once
they have been subjected to such external mechanical impacts.
1.8 Use in a Suitably Protected Environment
If Maxicaps®MR Virosart®are intended to be pressurized during use, this may
only take place in a suitably protected environment; additionally protective
clothing and safety glasses must be worn.
1.9 Product Change
At minimum, the Maxicaps®MR Virosart®should be replaced at the latest,
when the maximum allowable differential pressure is reached orwhen the
validated process volume has been processed over the filter.

10 Instructions for Use Maxicaps®MR Virosart®HF, Max and Media
General Information
1.10 Application Support
If needed, please request the corresponding documents with further
technical data, on how to carry out product integrity tests or special
information about additional applications. Moreover, if you have specific
questions about product validation, you can also contact ourValidation
Service or ourTechnical Support departments, theywill be happy to assist
youwithalltechnicalquestionsandoptimizationprocedures.
1.11 Returning Used Filter Elements
IMPORTANT
Before returning used filter elements to Sartorius Stedim Biotech for addi-
tional testing, make sure that they have been sterilized and decontaminated
properly. This has to be certified in the required Return Shipment Form that
you can order from your local Sartorius Stedim Biotech representative.
Otherwise, the provisions of the Employment Protection Act prohibit us from
processing the returned products.
1.12 Liability
Sartorius Stedim Biotech does not assume liability if the filter devices are
handled improperly.
In the interest of further developing Sartorius Stedim Biotech products, we
reserve the right to make changes to the product.
Consider possible national regulations regarding use of pressure equipment.

Instructions for Use Maxicaps®MR Virosart®HF, Max and Media 11
General Product Description
2 General Product Description
Maxicaps®MR Virosart®is a single-use device for large scale virus filtration.
Gamma-irradiatable filters can be delivered pre-sterilized but cannot be
gamma irradiated multiple times.
The device includes either 2, 3, 4, 5 or 6 filters of 2.4 m2of process modules
Virosart®HF filter elements, 3 or 6 of process modules 1.0 m2Virosart®Media
or 3, 6 or 9 30” Maxicaps®filter elements for Virosart®Max, which are
connected in parallel.The venting is performed centrally through a dedicated
venting line with a sterilizing grade venting filter.
Product Name Order Code
Maxicaps®MR2 Virosart®HF 3VI--28-MCG-MR2
Maxicaps®MR3 Virosart®HF 3VI--28-MCG-MR3
Maxicaps®MR4 Virosart®HF 3VI--28-MCG-MR4
Maxicaps®MR5 Virosart®HF 3VI--28-MCG-MR5
Maxicaps®MR6 Virosart®HF 3VI--28-MCG-MR6
Product Name Order Code
Maxicaps®MR3 Virosart®Media 3V2--28-IVG-MR3
Maxicaps®MR6 Virosart®Media 3V2--28-IVG-MR6
Product Name Order Code
Maxicaps®MR3 Virosart®Max 54A7358N3--MR3
Maxicaps®MR6 Virosart®Max 54A7358N3--MR6
Maxicaps®MR9 Virosart®Max 54A7358N3--MR9

12 Instructions for Use Maxicaps®MR Virosart®HF, Max and Media
General Product Description
The tubing sets of the Maxicaps®MR Virosart®allow either sterile connection
via AseptiQuik®* connectors or alternatively connection via Tri-Clamp con-
nectors. For the use of the Tri-Clamp connector the sterile connector needs
to be removed manually. Reinforced tubing is used for all tubing sets.
The tubing sets for the Maxicaps®MR Virosart®are constructed as following:
−Inlet connection: 2 AseptiQuik®with reinforced tubes
−Outlet connection: 2 AseptiQuik®with reinforced tubes (for Maxicaps®MR
Virosart®HF an additional outlet with AseptikQuik®and flow restrictor is
implemented)
−Venting connection: sterilizing grade venting filter with reinforced tube
and gauge glass
The Maxicaps®MR is delivered with tube clamps either PharmaLok™** from
Nordson MEDICAL or Pure-Fit®*** from Saint-Gobain Performance Plastics.
Please refer to the manufacturer’s instructions for use of the respective tube
clamp.
Pure-Fit®tube clamp PharmaLok™ tube clamp
Thetemperaturerangeforoperationshouldbebetween10°C|50°Fand
35°C|95°F.
The integrity test can be done with an integrity testing device (Sartocheck®)
by performing diffusion test. The integrity testing of the device is performed
by connecting the Sartocheck®to the venting line (sterile testing) or inlet line
(nonsterile testing).
Pleasereadthismanualcarefullytocorrectlyclose|disconnect(with
valve|clamp)thedevicepriortointegritytesting!
* AseptiQuik®is a registered trademarkof the Colder Products Company
** PharmaLok™ is a trademarkof Nordson MEDICAL
*** Pure-Fit®is a trademark of Saint-Gobain Performance Plastics

Instructions for Use Maxicaps®MR Virosart®HF, Max and Media 13
Parts Overview
3 Parts Overview
1
4
5
7
6
5
8
9
10
32
3
Pos. Description
1 Air Filter (Sartopore®Air)
2 Air Filter Holder
3 Inlet (AseptiQuik®above Tri-Clamp)
4 The ITwetting kit is implemented forVirosart®HF only. When used
for wetting, the kit ensures a defined back pressure needed for a
successful IT testing.
5 Outlet (AseptiQuik®above Tri-Clamp)
6ReinforcedSiliconTube¾”x⁹⁄₈”(IDxOD)
7Outlet Valve
8Inlet Valve
9ReinforcedSiliconTube¾”x⁹⁄₈”(IDxOD)
10 Venting Line Valve

14 Instructions for Use Maxicaps®MR Virosart®HF, Max and Media
Parts Overview
3.1 Inlet Tube
8933
Pos. Description
3 Inlet (AseptiQuik®above Tri-Clamp)
8Inlet Valve
9ReinforcedSiliconTube¾”x⁹⁄₈”(IDxOD)

Instructions for Use Maxicaps®MR Virosart®HF, Max and Media 15
Parts Overview
3.2 Outlet Tube for Virosart®HF Filter
76
5
5 4 5
Pos. Description
4 The ITwetting kit is implemented forVirosart®HF only. When used
for wetting, the kit ensures a defined back pressure needed for a
successful IT testing.
5 Outlet (AseptiQuik®above Tri-Clamp)
6ReinforcedSiliconTube¾”x⁹⁄₈”(IDxOD)
7Outlet Valve

16 Instructions for Use Maxicaps®MR Virosart®HF, Max and Media
Parts Overview
3.3 Outlet Tube forVirosart®Max and Media Filter
7655
Pos. Description
5 Outlet (AseptiQuik®above Tri-Clamp)
6ReinforcedSiliconTube¾”x⁹⁄₈”(IDxOD)
7Outlet Valve

Instructions for Use Maxicaps®MR Virosart®HF, Max and Media 17
General Process Description
4 General Process Description
The virus filtration is typically performed in the following steps:
Recommended
Optional
To be performed offline
2. Wetting for Pre-
Use-Integrity-Test
2.1 Pre-Use-
Integrity-Test
WFI Waste
Venting 3. Wetting for
operations
4. Equilibration
5. Filtration
6. Post-Flush
7. Wetting for Post-
Use-Integrity-Test
8. Post-Use-
Integrity-Test
WFI
Buffer
Feed
Buffer
WFI
Waste
Waste
Filtrate
Filtrate
Waste
Venting
Venting
Venting
1. Installation

18 Instructions for Use Maxicaps®MR Virosart®HF, Max and Media
Installation
5 Installation
IMPORTANT
Pallet hats are used to improve careful shipment
and handling. Maxicaps®MR Virosart®packaging
is qualified (ASTM D4169-09, DC 2, Assurance
Level 2) to withstand a plane top load of at least
700kg|1543lbs.Anundamagedcardboardbox
is the main indicator for correct shipment.
5.1 Unpacking and Transfer
toCleanRoom
1. Remove the cardboard packaging. Handle
with care, avoid mechanical impact on the
system.
2. Transfer Maxicaps®MR Virosart®in the
horizontal position as indicated by the label
on a roller cart into the air lock.
This Side Up For
Unpacking
Cut With Caution

Instructions for Use Maxicaps®MR Virosart®HF, Max and Media 19
Installation
3. Inside the air lock carefully remove the outer
plastic bag (one of the two). If using a cutter
take extra care not to damage the underlying
bag and the tubing of the device.
4. Pull the plastic bag down to floor. Lift one end
of the Maxicaps®MR Virosart®, roll the bag
out to the side, lift the other end pull bag
away completely.
5. Transfer the Maxicaps®MR Virosart®into the
clean room.
6. Inside the clean room remove the second
plastic bag. Follow the same procedures as
described above.

20 Instructions for Use Maxicaps®MR Virosart®HF, Max and Media
Installation
7. Be sure that the Maxicaps®MR Virosart®is
upright: the air filter should be on top side and
the wheels should stand on the ground. Re-
move all pink foam from the Maxicaps®MR
Virosart®.
Fig.1: Before Fig.2: After
5.2 Installation Manual
Actuators
1. Install and fixate the manual actuator* of the
diaphragm valve onto the inlet valve (8),
venting line valve (10) and outlet valve (7).
Please refer to the instructions for use of the
GEMܮvalve. After the installation, the
GEMܮvalves are slightly open. Please close
all of the valves, as indicated by the arrows on
the actuator.
* 3 reusable manual actuators are needed for the
3 SU valves. Order Code: BPR0202