Sartofluor® MidiCaps® and Capsules

Specifications

Materials
Membrane: PTFE
Support fleece: Polypropylene
Core: Polypropylene
Membrane Filter

End caps: Polypropylene

Capsule Housing: Polypropylene
O-Rings: EPDM
Filling Bell: Polycarbonate

Pore Sizes
0.1 μm (only MidiCaps®)
0.2 μm (MidiCaps® & Capsules)
0.45 μm (only MidiCaps®)

Available Sizes|Filtration Area

Description Performance MidiCaps®

Sartofluor® MidiCaps® and Capsules 0.2 μm The unique hydrophobic single layer PTFE Size 7 0.05 m2 |0.54 ft2
rated are self contained, ready to use, sterile membrane provides outstanding flow rates Size 8 0.1 m2 |1.1 ft2
filter units for sterilizing grade filtration in for gases and liquids at low differential pres- Size 9 0.2 m2 |2.2 ft2
the pharma|biotech industry. Their unique sure assuring most economic system design. Size 0 0.45 m2 |4.8 ft2
hydrophobic PTFE membrane is ideally suited
for particle removal and sterilizing grade Cost Saving Capsules
filtration of gases and for filtration of highly The use of the disposable capsule design con- Size 4 0.015 m2 |0.16 ft2
aggressive liquids like solvents, acids and cept avoids investments into stainless steel Size 5 0.03 m2 |0.32 ft2
bases. filter housings and eliminates additional
costs for cleaning of housings and cleaning Available Connectors MidiCaps®
Applications validation. SS, SO, OO, FF, FO, FH, HH (only for size 7)
Typical applications include sterile venting of:
– Fermenters Microbiological Retention Available Connectors Capsules
– Vessels Sartofluor® MidiCaps® and Capsules 0.2 μm SS, SO, OO (Size 4)
– Glass Bottles rated are fully validated as sterilizing grade OO (Size 5)
filters according to HIMA and ASTM F-838-05
The hydrophobic PTFE membrane is also suit- guidelines. S: 11” Tri-Clamp (Sanitary)
able for filtration of aggressive liquids like: O: 1” Single stepped hose barb
– Acids|Bases Quality Control F: 3” Tri-Clamp (Sanitary)
– Solvents Each individual element is tested for integrity H: 4” Multiple stepped hose barb
by B.-P. and Diffusion-Test prior to be (with filling bell at the outlet)
Easy to use released assuring absolute reliability.
Sartofluor® MidiCaps® and Capsules are deliv- Operating Parameters
ered as individually packed sterile units. On Documentation Max. allowable 5 bar|72.5 psi
site, pre-use sterilization can be eliminated. Sartofluor® MidiCaps® and Capsules are Differential pressure: at 20°C (MidiCaps®)
designed, developed and manufactured in 4 bar|58 psi
Flexibility accordance with a ISO 9001 certified Quality at 20°C (Capsules)
Sartofluor® MidiCaps® and Capsules are Management System. A Validation Guide is
available with various filtration areas from available for compliance with regulatory Max. allowable back 2 bar|29 psi at 20°C
150 cm2 | 0.16 ft2 up to 0,45 m2 | 4.8 ft2 for requirements. Pressure:
easy adoption to any filtration process
independent from the batch size.
Specifications Air Flow Rates for Sartofluor® MidiCaps®, 0.2 μm rated with SS-connector

Extractables
Sartofluor® MidiCaps® and Capsules meet, Differential Pressure [bar] [psi]
0.4 5.8
or exceed the requirements for WFI quality
standards set by the current USP.
Size 7 Size 8 Size 9
0.3
Regulatory Compliance
Individually integrity tested
0.2 2.9
Integrity test correlated to HIMA |ASTM
F 838-05 Bacteria Challenge Test 0.1

Non pyrogenic according to USP Bacterial

0 0
Endotoxins
0 20 40 60 80 100 120 140 160
Pass USP Plastic Class VI Test Air Flow Rate [m3/h]
Non fiber releasing according to 21 CFR

Air Flow Rates for Sartofluor® Capsules, 0.2 μm rated with SS-connector
Sterilization

Autoclaving: Air flow rate [l/min]

134°C, 2 bar, 30 min 140

No In-Line Steam Sterilization 120

Sartofluor 300
100
Sterilization Cycles
Autoclaving: Min. 25 80
60
Sartofluor 150
Technical References
40
Validation Guide: 20
SPK5711-e (MidiCaps®)
0
0 50 100 150 200
Differential Pressure [mbar]

Order Information Sartorius Stedim Biotech GmbH

August-Spindler-Strasse 11
Order Code Pore size Pack size Test Pressure Max. Diffusion Min. Bubble Point 37079 Goettingen, Germany
[μm] [pieces] [bar|psi] [ml|min] [bar|psi] Phone +49.551.308.0
MidiCaps®: Fax +49.551.308.3289
5185307T7--**--A 0.2 4 0.7 |10.2 2 1.0|14.5 www.sartorius-stedim.com
5185307T8--**--A 0.2 4 0.7 |10.2 3 1.0|14.5
USA Toll-Free +1.800.368.7178
5185307T9--**--A 0.2 4 0.7 |10.2 4 1.0|14.5
UK +44.1372.737159
5185307T0--**--V 0.2 2 0.7 |10.2 8 1.0|14.5
France +33.442.845600
5185306T7--**--A 0.45 4 0.4 |5.8 1 0.6|8.7
Italy +39.055.63.40.41
5185306T8--**--A 0.45 4 0.4 |5.8 2 0.6|8.7
Spain +34.90.2110935
5185306T9--**--A 0.45 4 0.4 |5.8 3 0.6|8.7
Japan +81.3.3740.5407
5185358T7--**--A 0.1 4 – – 1.5|22
5185358T8--**--A 0.1 4 – – 1.5|22 Specifications subject to change
5185358T9--**--A 0.1 4 0.9 |13.1 5 1.5|22 without notice. Printed and copyrighted
by Sartorius Stedim Biotech GmbH. | W
Publication No.: SPK2067-e11067
Capsules: Order No.: 85030-522-62
Ver. 06 | 2011
5181307T4--**--B 0.2 4 – – 1.0|14.5
5181307T5—OO—D 0.2 10 – – 1.0|14.5

**: Connector Styles