sterilizing grade and mycoplasma retentive midicaps ... · quality control each individual element...

Specifications

Materials

Prefilter Membrane: Polyethersulfone, asymmetric

Endfilter Membrane: Polyethersulfone, asymmetric

Support Fleece: PolypropyleneCore: PolypropyleneEnd Caps: PolypropyleneCapsule Housing: Polypropylene O-Rings: SiliconeFilling Bell: Polycarbonate

Pore Size 0.2 µm + 0.1 µm

Available Sizes | Filtration Area

Capsules Size 4 0.015 m2|0.16 ft2Size 5 0.03 m2|0.32 ft2

MidiCaps® Size 7 0.05 m2|0.5 ft2Size 8 0.1 m2|1.1 ft2Size 9 0.2 m2|2.2 ft2Size 0 0.45 m2|4.8 ft2

MaxiCaps®Size 1 0.6 m2|6.5 ft2Size 2 1.2 m2|12.9 ft2Size 3 1.8 m2|19.4 ft2

Available Connectors CapsulesSS, SO, OO

Available Connectors MidiCaps®SS, SO, OO, FF, FO, HH (only size 7)

Available Connectors MaxiCaps®SS, SO, OO, FF, BB

S: 11” Tri-Clamp (Sanitary)O: 1” Single stepped hose barbF: 3” Tri-Clamp (Sanitary)H: 4” Multiple stepped hose barb

(with filling bell at the outlet)B: 3” – 1” Multiple stepped hose barbS: 1” Tri-Clamp (only Capsule Size 4)O: Multiple stepped hose barb

(Capsule Size 4 & 5)

Operating Parameters

Max. Allowable Differential Pressure:

5 bar|72.5 psi at 20°C(MidiCaps®)3 bar| 43.5 psi at20°C (MaxiCaps®)2 bar| 29 psi at 80°C

Max. Allowable Back Pressure:

2 bar|29 psi at 20°C

Description Sartopore® 2 0.1 µm rated MidiCaps®, MaxiCaps® and Capsules are self-contained, ready-to-use membrane filter units for validated sterile filtration and reliable Mycoplasma removal in the pharma|biotech industry.

ApplicationsTypical applications include sterilizing grade filtration and Mycoplasma removal from:– Animal Sera– Cell Culture Media– Media Components– Bioprocessed Pharmaceuticals– Prefiltration infront of virus filters– Biological Fluids

and any other application requiring sub 0.2 µm filtration for enhanced sterility assurance.

CompatibilityThe polyethersulfone membrane is compatible with a pH-range from pH 1 to pH 14 making Sartopore® 2 MidiCaps®, MaxiCaps® and Capsules ideal for filtration of solutions with high| low pH.

Easy to useSartopore® 2 MidiCaps® and Capsules are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated.

FlexibilitySartopore® 2 0.1 µm MidiCaps®, MaxiCaps® 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.

ScalabilityConsistent and predictable scale-up and down trials can reliably be performed as all Sartopore® 2 MidiCaps®, MaxiCaps® and Capsules are produced with the same type of membrane and materials and identical construction.

Cost SavingThe use of the disposable capsule design concept avoids investments into stainless steel filter housings and eliminates additional costs for cleaning of housings and cleaning validation.

Microbiological RetentionSartopore® 2 0.1 µm MidiCaps®, MaxiCaps® and Capsules are validated as sterilizing grade fil-ters according to ASTM F 838-83 standard and for Mycoplasma removal with a Log Reduction Value (LRV) of 7 for Acholeplasma laidlawii.

Quality Control Each individual element is tested for integrity by Diffusion-Test prior to be released assuring absolute reliability.

DocumentationSartopore® 2 MidiCaps®, MaxiCaps® 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.

Sartopore® 2 0.1 µmSterilizing Grade and Mycoplasma Retentive MidiCaps®, MaxiCaps® and Capsules

Mid

iCap

s &

Max

iCap

s

Specifications

ExtractablesSartopore® 2 0.1 µm MidiCaps®, MaxiCaps® 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 838-83 Bacteria Challenge Test and Myco-plasma removal.

Non pyrogenic according to USP Bacterial Endotoxins

Pass USP Plastic Class VI Test

Non fiber releasing according to 21 CFR

Sterilization

Autoclaving: 134 °C, 2 bar, 30 min

No In-Line Steam Sterilization

Sterilization CyclesAutoclaving: Min. 25

Technical References

Validation Guide:SPK5732-e

Extractables Guide:SPK5731-e

Water Flow Rates for MidiCaps® with SS inlet and outlet

Water Flow Rates for MaxiCaps®

Order Information Order Code Pore size Pack size Test Pressure Max. Diffusion [µm] [Pieces] [bar|psi] [ml/min]Capsules: 5441358K4--**--B 0.1 5 4.0|58 1 5441358K5--**--B 0.1 5 4.0|58 2 MidiCaps®:5445358K7--**--A 0.1 4 4.0|58 4 5445358K8--**--A 0.1 4 4.0|58 6 5445358K9--**--A 0.1 4 4.0|58 9 5445358K0--**--V 0.1 2 4.0|58 18 MaxiCaps®:5441358K1--** 0.1 1 4.0|58 24 5441358K2--** 0.1 1 4.0|58 48 5441358K3--** 0.1 1 4.0|58 72 **: Connector Styles

Sartorius Stedim Biotech GmbH August-Spindler-Strasse 11 37079 Goettingen, GermanyPhone +49.551.308.0 Fax +49.551.308.3289 www.sartorius-stedim.com

USA Toll-Free +1.800.368.7178 UK +44.1372.737159 France +33.442.845600 Italy +39.055.63.40.41 Spain +34.90.2110935 Japan +81.3.3740.5407

Specifications subject to change without notice. Printed and copyrighted by Sartorius Stedim Biotech GmbH. | WPublication No.: SPK2063-e11054Order No.: 85030-521-84Ver. 05 | 2011

Standardized at 20°C

Differential pressure [bar] [psi]1

0.75

0.5

0.25

00

Flow Rate [l/h]

Size 7 Size 8 Size 9 Size 0

14.5

7.25

0500 1000 1500 2000


0.75

0.5

0.25

00 1000 2000 3000 4000 5000

Flow Rate [l/h]

10 20 30

15

7.5

0

Specifications

Materials





Available Sizes | Filtration Area

Capsules Size 4 0.015 m2|0.16 ft2Size 5 0.03 m2|0.32 ft2



Available Connectors CapsulesSS, SO, OO



S: 11” Tri-Clamp (Sanitary)O: 1” Single stepped hose barbF: 3” Tri-Clamp (Sanitary)H: �4” Multiple stepped hose barb

(with filling bell at the outlet)B: 3” – 1” Multiple stepped hose barb



5 bar|72.5 psi at 20°C (MidiCaps®)3 bar| 43.5 psi at20°C (MaxiCaps®)2 bar| 29 psi at 80°C



Description Sartopore® 2 0.2 µm MidiCaps®, MaxiCaps® and Capsules are self contained, ready to use, sterile filter units for sterilizing grade filtra-tion in the pharma|biotech industry. Made of a unique hydrophilic heterogeneous double layer Polyethersulfone membrane, Sartopore® 2 MidiCaps®, MaxiCaps® and Capsules are designed for convenient sterile filtration of a broad range of pharmaceutical products.

ApplicationsTypical applications include sterilizing grade filtration of:– Therapeutics– Biological Fluids– Injectables– Media– Buffers– Chemicals– Cleaning and sanitizing agents




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.

ScalabilityConsistent and predictable scale-up and down trials can reliably be performed as all Sartopore® 2 MidiCaps®, MaxiCaps® and Capsules are produced with the same type of membrane and materials and identical con-struction.

Cost SavingThe use of the disposable capsule design concept avoids investments into stainless steel filter housings and eliminates additional costs for cleaning of housings and cleaning validation.

Microbiological RetentionSartopore® 2 0.2 µm rated MidiCaps®, MaxiCaps® and Capsules are fully validated as sterilizing grade filters according to HIMA and ASTM F-838-83 guidelines.

Quality Control Each individual element is tested for integ-rity by B.-P. and Diffusion-Test prior to be released assuring absolute reliability.


Sartopore® 2 0.2 µmSterilizing Grade MidiCaps®, MaxiCaps® and Capsules

Mid

iCap

s &

Max

iCap

s

Specifications

ExtractablesSartopore® 2 0.2 µm rated MidiCaps®, MaxiCaps® and Capsules meet, or exceed the requirements for WFI quality standards set by the current USP.


Integrity test correlated to HIMA/ASTM F 838-83 Bacteria Challenge Test




Sterilization

Autoclaving: 134 °C, 2 bar, 30 min







Water Flow Rates for MaxiCaps®

Order Information

Order Code. Pore size Pack size Test Max. Min. [µm] [Pieces] Pressure Diffusion Bubble Point [bar|psi] [ml/min] [bar|psi]Capsules: 5441307H4--**--B 0.2 5 2.5|36 1 3.2|46 5441307H5--**--B 0.2 5 2.5|36 2 3.2|46 MidiCaps®:5445307H7--**--A 0.2 4 2.5|36 4 3.2|465445307H8--**--A 0.2 4 2.5|36 5 3.2|465445307H9--**--A 0.2 4 2.5|36 7 3.2|465445307H0--**--V 0.2 2 2.5|36 14 3.2|46 MaxiCaps®:5441307H1--** 0.2 1 2.5|36 18 3.2|465441307H2--** 0.2 1 2.5|36 36 3.2|465441307H3--** 0.2 1 2.5|36 54 3.2|46

**: Connector Styles


USA Toll-Free +1.800.368.7178 UK +44.1372.737159 France +33.442.845600 Italy +39.055.63.40.41 Spain +34.90.2110935 Japan +81.3.3740.5407




0.75

0.5

0.25

00

Flow Rate [l/h]


14.5

7.25

01000 2000 3000 4000 5000


0.75

0.5

0.25

00 2000 4000 6000 8000 10000 12000 14000

Flow Rate [l/h]

10 20 30

15

7.5

0

Specifications

Materials





Available Sizes|Filtration Area

Capsules Size 5 0.03 m2|0.32 ft2



Available Connectors CapsulesOO



S: 11” Tri-Clamp (Sanitary)O: 1” Single stepped hose barbF: 3” Tri-Clamp (Sanitary)H: �4” Multiple stepped hose barb

(with filling bell at the outlet) B: 3” – 1” Multiple stepped hose barb



5 bar|72.5 psi at 20°C (MidiCaps®)3 bar| 43.5 psi at20°C (MaxiCaps®)2 bar| 29 psi at 80°C



Description Sartopore® 2 0.45 µm rated MidiCaps®, MaxiCaps® and Capsules are self contained, ready to use filter units for bioburden reduction and particle removal from a broad range of pharmaceutical products. Membrane prefiltration of aqueous solutions and highly viscous pharmaceutical products difficult to filter can effectively be accomplished due to the outstanding total throughput and flow rate performance of Sartopore® 2 0.45 µm MidiCaps®, MaxiCaps® and Capsules.

ApplicationsTypical applications include bioburden reduction and particle removal from:– Therapeutics– Injectables– Buffers– Biological Fluids– Tissue Culture Media– Acetic and basic solutions




filtration areas from 300 cm2 | 0.32 ft2 up to 1.8 m2 | 19.4 ft2 and various connector styles for easy adoption to any filtration process independent from the batch size.

ScalabilityConsistent and predictable scale-up and down trials can reliably be performed as all Sartopore® 2 MidiCaps®, MaxiCaps® and Capsules are produced with the same type of membrane and materials and identical construction.

Cost SavingThe use of the disposalbe capsule design con-cept avoids investments into stainless steel fil-ter housings and eliminates additional costs for cleaning of housings and cleaning validation.

Microbiological RetentionSartopore® 2 0.45 µm rated MidiCaps®, MaxiCaps® and Capsules are fully validated with a Log Reduction Value (LRV) of 7 for Serratia Marcescens according to HIMA and ASTM F-838 83 procedures.

Quality Control Each individual element is tested for integrity by B.-P. and Diffusion-Test prior to be released assuring absolute reliability.


Sartopore® 2 0.45 µmBioburden & Particle Retentive MidiCaps®, MaxiCaps® and Capsules

Mid

iCap

s &

Max

iCap

s

Specifications

ExtractablesSartopore® 2 0.45 µm rated MidiCaps®, MaxiCaps® and Capsules meet, or exceed the requirements for WFI quality standards set by the current USP.


Integrity test correlated to Bacteria Challenge Test using Serratia marcescens following HIMA/ASTM methodologies.




Sterilization

Autoclaving:134°C, 2 bar, 30 min







Water Flow Rates for Sartopore® 2 MaxiCaps®


Order Information Order Code Pore size Pack size Test Max. Min. [µm] [Pieces] Pressure Diffusion Bubble Point [bar|psi] [ml/min] [bar|psi]Capsules: 5441306G5--OO--B 0.45 5 1.7|25 2 2.2|32 MidiCaps®: 5445306G7--**--A 0.45 4 1.7|25 3 2.2|32 5445306G8--**--A 0.45 4 1.7|25 4 2.2|32 5445306G9--**--A 0.45 4 1.7|25 6 2.2|32 5445306G0--**--V 0.45 2 1.7|25 12 2.2|32 MaxiCaps®:5441306G1--** 0.45 1 1.7|25 12 2.2|32 5441306G2--** 0.45 1 1.7|25 24 2.2|32 5441306G3--** 0.45 1 1.7|25 36 2.2|32 **: Connector Styles


USA Toll-Free +1.800.368.7178 UK +44.1372.737159 France +33.442.845600 Italy +39.055.63.40.41 Spain +34.90.2110935Japan +81.3.3740.5407


0 2500 5000 7500 10000

Flow Rate [l/h]

0

0.1

0.2

0.3

0.4

0.5Differential Pressure [bar]

0

1.5

3

4.5

6

7.5[psi]

10" 20" 30"

Differential pressure [bar] [psi]0.5

0.25

00

Flow Rate [l/h]


7.25

01000 2000 3000 4000

Data_Sartopore2-0.1_MidiCaps_SPK2063-e.pdfData_Sartopore2-0.2_MidiCaps_SPK2062-e.pdfData_Sartopore2-0.45_MidiCaps_SPK2061-e.pdf

sterilizing grade and mycoplasma retentive midicaps ... · quality control each individual element...

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