Sartobran® P 0.2 μm — Sterilizing Grade
4
Membrane Filter MidiCaps ® & MaxiCaps ® Scalability Consistent and predictable scale-up and down trials can reliably be performed as all Sartobran ® P (T-Style) MaxiCaps ® , MidiCaps ® and Capsules are produced with the same type of membrane and identical materials of construction. Cost Saving The use of the disposable capsule design concept avoids invest- ments into stainless steel filter housings and eliminates additional costs for cleaning of housings and cleaning validation. Microbiological Retention Sartobran ® P (T-Style) MaxiCaps ® , MidiCaps ® and Capsules 0.2 µm rated are fully validated as sterilizing grade filters according to HIMA and ASTM F-838-05 guidelines. Quality Control Each individual element is tested for integrity by Bubble Point and Diffusion test prior to be released assuring absolute reliability. Documentation Sartobran ® P (T-Style) MaxiCaps ® , MidiCaps ® and Capsules are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements. Applications Sartobran ® P filter elements have proven throughout the years to be the first choice for all applications in the biopharmaceutical industry requiring low adsorption capabilities. They are typically used for sterilizing grade filtration of: – Coagulation Factors, Albumin, IgG – Bacterial & Viral Vaccines – MAB – Bio-processed Pharmaceuticals – Diagnostics – Purified Protein Solutions – Biological Fluids – Fluids containing preservatives Easy to use Sartobran ® P (T-Style) MaxiCaps ® , MidiCaps ® and Capsules are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated. Flexibility Sartobran ® P 0.2 (T-Style) MaxiCaps ® , MidiCaps ® and Capsules are available with various filtration areas from 150 cm 2 | 0.16 ft 2 up to 1.8 m 2 | 19.4 ft 2 for easy adoption to any filtration process independent from the batch size. Sartobran ® P 0.2 µm Sterilizing Grade (T-Style) MaxiCaps ® , MidiCaps ® and Capsules Sartobran ® P 0.2 (T-Style) MaxiCaps ® , MidiCaps ® and Capsules are self contained, ready to use, sterile filter units for sterilizing grade filtration in the pharma | bio- tech industry. The extremely low unspecific adsorption of their cellulose acetate membranes assures highest protein yields and rapid preservative recovery. Product Information
Transcript of Sartobran® P 0.2 μm — Sterilizing Grade
Membrane Filter MidiCaps® & MaxiCaps®
ScalabilityConsistent and predictable scale-up and down trials can reliably be performed as all Sartobran® P (T-Style) MaxiCaps®, MidiCaps® and Capsules are produced with the same type of membrane and identical materials of construction.
Cost SavingThe use of the disposable capsule design concept avoids invest-ments into stainless steel filter housings and eliminates additional costs for cleaning of housings and cleaning validation.
Microbiological RetentionSartobran® P (T-Style) MaxiCaps®, MidiCaps® and Capsules 0.2 µm rated are fully validated as sterilizing grade filters according to HIMA and ASTM F-838-05 guidelines.
Quality Control Each individual element is tested for integrity by Bubble Point and Diffusion test prior to be released assuring absolute reliability.
DocumentationSartobran® P (T-Style) MaxiCaps®, MidiCaps® and Capsules are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements.
ApplicationsSartobran® P filter elements have proven throughout the years to be the first choice for all applications in the biopharmaceutical industry requiring low adsorption capabilities. They are typically used for sterilizing grade filtration of:– Coagulation Factors, Albumin, IgG– Bacterial & Viral Vaccines– MAB– Bio-processed Pharmaceuticals– Diagnostics– Purified Protein Solutions– Biological Fluids– Fluids containing preservatives
Easy to useSartobran® P (T-Style) MaxiCaps®, MidiCaps® and Capsules are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated.
FlexibilitySartobran® P 0.2 (T-Style) MaxiCaps®, MidiCaps® and Capsules are available with various filtration areas from 150 cm2 | 0.16 ft2 up to 1.8 m2 | 19.4 ft2 for easy adoption to any filtration process independent from the batch size.
Sartobran® P 0.2 µmSterilizing Grade (T-Style) MaxiCaps®, MidiCaps® and Capsules
Sartobran® P 0.2 (T-Style) MaxiCaps®, MidiCaps® and Capsules are self contained, ready to use, sterile filter units for sterilizing grade filtration in the pharma | bio-tech industry. The extremely low unspecific adsorption of their cellulose acetate membranes assures highest protein yields and rapid preservative recovery.
Product Information
Specifications
Materials
Prefilter Membrane Cellulose Acetate
Endfilter Membrane Cellulose Acetate
Support Fleece Polypropylene
Core Polypropylene
End caps Polypropylene
Capsule Housing Polypropylene
O-Rings Silicone
Filling Bell Polycarbonate
Pore Size Combination
0.45 µm + 0.2 µm
Available Sizes | Filtration Area
(T-Style) MaxiCaps®
Size 1 10” 0.6 m2 | 6.5 ft2
Size 2 20” 1.2 m2 | 12.9 ft2
Size 3 30” 1.8 m2 | 19.4 ft2
MidiCaps®
Size 7 0.05 m2 | 0.54 ft2
Size 8 0.1 m2 | 1.1 ft2
Size 9 0.2 m2 | 2.2 ft2
Size 0 0.45 m2 | 4.8 ft2
Capsules
Size 4 0.015 m2 | 0.16 ft2
Size 5 0.03 m2 | 0.32 ft2
Available Connectors (T-Style) MaxiCaps®, MidiCaps®
S: Tri-Clamp 50 mm (11”)O: 1” single stepped hose barbF: Tri-Clamp 25 mm (3”) (only MaxiCaps®)Y: 1” single stepped hose barb (only T-Style MaxiCaps®)
Available Connectors CapsulesS: Tri-Clamp 25 mm (3”)O: 4” multiple stepped hose barb
Operating Parameters
Max. Allowable Differential Presure
5 bar | 72.5 psi at 20°C(T-Style MaxiCaps®, MaxiCaps®, MidiCaps®)4 bar | 58 psi at 20°C (Capsules)2 bar | 29 psi at 80°C(MidiCaps®, Capsules)3 bar | 43.5 psi at 50°C(T-Style MaxiCaps®, MaxiCaps®)
Max. Allowable Back Pressure 2 bar | 29 psi at 20°C
ExtractablesSartobran® P 0.2 (T-Style) MaxiCaps®, MidiCaps® and Capsules meet, or exceed the requirements for WFI quality standards set by the current USP.
Regulatory ComplianceIndividually integrity tested
Integrity test correlated to HIMA/ASTM F 838-05 Bacteria Challenge Test
Non pyrogenic according to USP Bacterial Endotoxins
Pass USP Plastic Class VI Test
Non-fiber releasing according to 21 CFR
pH Compatibility Sartobran® P filters have a limited pH compatibility in the range of pH 4 – 8.
This range covers most of the relevant bio-pharmaceutical applications.
Sterilization
Autoclaving134°C, 2 bar, 30 min
No In-Line Steam Sterilization
Sterilization CyclesT-Style MaxiCaps®
Autoclaving Min. 5MaxiCaps® | MidiCaps® | CapsulesAutoclaving Min. 25
Technical ReferencesValidation Guide SPK5726-e
Technical Data
Membrane Filter MidiCaps® & MaxiCaps®
Differential pressure [bar] [psi]
Size 7 Size 8 Size 9 Size 0
14.5
7.25
0
1
0.75
0.5
0.25
00
Flow Rate [l/h]
500 1000 1500 25002000
Differential pressure [bar] [psi]1
0.75
0.5
0.25
00
Flow Rate [l/h]
Size 1 Size 2 Size 3
14.5
0800060002000 4000
7.25
3
Order Code Pore Size [µm]
Pack Size [Pieces]
Test Pressure [bar | psi]
Max. Diffusion [ml/min]
Min. Bubble Point [bar | psi]
T-Style MaxiCaps®
5238307H1--** 0.2 1 2.5 | 36 15 3.2 | 46
5238307H2--** 0.2 1 2.5 | 36 30 3.2 | 46
5238307H3--** 0.2 1 2.5 | 36 45 3.2 | 46
MaxiCaps®
5237307H1--** 0.2 1 2.5 | 36 15 3.2 | 46
5237307H2--** 0.2 1 2.5 | 36 30 3.2 | 46
5237307H3--** 0.2 1 2.5 | 36 45 3.2 | 46
MidiCaps®
5235307H7--**--A 0.2 4 2.5 | 36 3 3.2 | 46
5235307H8--**--A 0.2 4 2.5 | 36 4 3.2 | 46
5235307H9--**--A 0.2 4 2.5 | 36 5 3.2 | 46
5235307H0--**--V 0.2 2 2.5 | 36 10 3.2 | 46
Capsules
5231307H4--**--B 0.2 5 2.5 | 36 1 3.2 | 46
5231307H5--OO--B 0.2 5 2.5 | 36 2 3.2 | 46
**: Connector Styles (first code letter represents the inlet, the second the outlet)
Water Flow Rates for MidiCaps® with SS adapter Water Flow Rates for MaxiCaps®
Standardized at 20°C
Ordering Information
Sales and Service ContactsFor further contacts, visit www.sartorius-stedim.com
EuropeGermanySartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen
Phone +49.551.308.0Fax +49.551.308.3289
Sartorius Stedim Systems GmbHRobert-Bosch-Strasse 5 – 7 34302 Guxhagen
Phone +49.5665.407.0Fax +49.5665.407.2200
FranceSartorius Stedim FMT S.A.S.ZI des PaludsAvenue de Jouques – CS 9105113781 Aubagne Cedex
Phone +33.442.845600Fax +33.442.845619
Sartorius Stedim France SASZI des PaludsAvenue de Jouques – CS 7105813781 Aubagne Cedex
Phone +33.442.845600Fax +33.442.846545
AustriaSartorius Stedim Austria GmbHFranzosengraben 121030 Vienna
Phone +43.1.7965763.18Fax +43.1.796576344
BelgiumSartorius Stedim Belgium N.V.Leuvensesteenweg, 248/B1800 Vilvoorde
Phone +32.2.756.06.80Fax +32.2.756.06.81
HungarySartorius Stedim Hungária Kft.Kagyló u. 52092 Budakeszi
Phone +36.23.457.227Fax +36.23.457.147
ItalySartorius Stedim Italy S.p.A.Via dell’Antella, 76/A50012 Antella-Bagno a Ripoli (FI)
Phone +39.055.63.40.41Fax +39.055.63.40.526
NetherlandsSartorius Stedim Netherlands B.V.
Phone +31.30.60.25.080Fax +31.30.60.25.099
PolandSartorius Stedim Poland Sp. z o.o.ul. Wrzesinska 7062-025 Kostrzyn
Phone +48.61.647.38.40Fax +48.61.879.25.04
Russian FederationLLC “Sartorius ICR”Uralskaya str. 4, Lit. B199155, Saint-Petersburg
Phone +7.812.327.5.327Fax +7.812.327.5.323
SpainSartorius Stedim Spain, S.A.U.Avda. de la Industria, 32Edificio PAYMA28108 Alcobendas (Madrid)
Phone +34.902.110.935Fax +34.91.358.96.23
SwitzerlandSartorius Stedim Switzerland AGRingstrasse 24 a8317 Tagelswangen
Phone +41.52.354.36.36Fax +41.52.354.36.46
U.K.Sartorius Stedim UK Ltd.Longmead Business CentreBlenheim Road, EpsomSurrey KT19 9 QQ
Phone +44.1372.737159Fax +44.1372.726171
AmericaUSASartorius Stedim North America Inc.5 Orville Drive, Suite 200Bohemia, NY 11716
Toll-Free +1.800.368.7178Fax +1.631.254.4253
ArgentinaSartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires
Phone +54.11.4721.0505 Fax +54.11.4762.2333
BrazilSartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP 09600-000 - SP- Brasil
Phone +55.11.4362.8900Fax + 55.11.4362.8901
MexicoSartorius de México S.A. de C.V.Circuito Circunvalación Poniente No. 149Ciudad Satélite53100, Estado de MéxicoMéxico
Phone +52.5555.62.1102Fax +52.5555.62.2942
Asia|PacificAustraliaSartorius Stedim Australia Pty. Ltd.Unit 5, 7-11 Rodeo DriveDandenong South Vic 3175
Phone +61.3.8762.1800Fax +61.3.8762.1828
ChinaSartorius Stedim Biotech (Beijing) Co. Ltd.No. 33 Yu’an RoadAirport Industrial Park Zone BShunyi District, Beijing 101300
Phone +86.10.80426516Fax +86.10.80426580
Sartorius Stedim Biotech (Beijing) Co. Ltd.Shanghai Branch Office3rd Floor, North Wing, Tower 1No. 4560 Jin Ke RoadPudong District, Shanghai 201210
Phone +86.21.68782300Fax +86.21.68782332 | 68782882
Sartorius Stedim Biotech (Beijing) Co. Ltd.Guangzhou Representative OfficeUnit K, Building 23Huihua Commerce & Trade BuildingNo. 80 Xianlie Middle RoadGuangzhou 510070
Phone +86.20.37618687 | 37618651Fax +86.20.37619051
IndiaSartorius Stedim India Pvt. Ltd.#69/2-69/3, NH 48, JakkasandraNelamangala Tq562 123 Bangalore, India
Phone +91.80.4350.5250Fax +91.80.4350.5253
JapanSartorius Stedim Japan K.K.4th Fl., Daiwa Shinagawa North Bldg.8-11, Kita-Shinagawa 1-chomeShinagawa-ku, Tokyo, 140-0001 Japan
Phone +81.3.4331.4300Fax +81.3.4331.4301
MalaysiaSartorius Stedim Malaysia Sdn. Bhd.Lot L3-E-3B, Enterprise 4Technology Park MalaysiaBukit Jalil57000 Kuala Lumpur, Malaysia
Phone +60.3.8996.0622Fax +60.3.8996.0755
SingaporeSartorius Stedim Singapore Pte. Ltd.1 Science Park Road, The Capricorn, #05-08A,Singapore Science Park IISingapore 117528
Phone +65.6872.3966Fax +65.6778.2494
South KoreaSartorius Korea Biotech Co., Ltd.8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-GuSeongNam-Si, GyeongGi-Do, 463-400
Phone +82.31.622.5700Fax +82.31.622.5799
www.sartorius-stedim.com Spec
ific
atio
ns s
ubje
ct t
o ch
ange
wit
hout
not
ice.
Prin
ted
in t
he E
U o
n pa
per b
leac
hed
wit
hout
chl
orin
e. |
W
Publ
icat
ion
No.
: SPK
2075
-e14
0907
· O
rder
No.
: 850
30-5
23-4
2 · V
er. 0
9 | 2
014
