readytoprocess NFF

7/31/2019 readytoprocess NFF

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GE Healthcare

Data file 28-9257-93 AB Filtration

ReadyToProcess

ULTA

NormalFlow Filter capsules and assembliesGE Healthcare ReadyToProcess Normal Flow Filter capsule

assemblies are disposable normal flow filters designed for

laboratory through process scale processing, with typical

volumes ranging from a few hundred milliliters to 1000 L of

solution.

Four ReadyToProcess NFF capsulesare presently being offered:ReadyCircuit ULTA SG Capsule Assembly: provides sterile

filtration of biopharmaceutical solutions

ReadyCircuit ULTA HC Capsule Assembly: for effective sterile

filtration of difficult-to-filter biopharmaceutical and diagnostic

solutions

ReadyCircuit ULTA CG Capsule Assembly: for controlling

bioburden and particle retention in a wide variety of pH

ranges and feed streams

ReadyCircuit ULTA GF Capsule Assembly: for effective

prefiltration/clarification of biopharmaceutical solutions

These filters are factory preconditioned so usually there is no

need for the user to rinse before use, and gamma irradiated

providing biostability. In addition to being easy-to-use and

saving time, low TOCs and endotoxins result from the

preconditioning regimen.

ReadyToProcessReadyToProcess is a suite of products that is designed to

bring a comprehensive offering of ready to processdisposables such as:

Cross flow filters (CFF)

Normal flow filters (NFF)

Pre-packed Chromatography columns

Single-use bioprocessing bags and tubing assemblies

Fermentors

Mixers

Sampling devices

These products are ready to use and disposable. Use of

ReadyToProcess products and technology will

Decrease risk of process cross-contamination

Simplify and speed bioprocessing

Reduce process development time inbioprocess operations

Lower capital investment/increase cash flow

Fig 1. ReadyToProcess NFF capsule filter attached to ReadyCircuit bag


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Features and benefits andmaterials of constructionPreconditioned: NFF capsule filters are preconditioned at the

factory, so the NFF capsule assemblies are ready to use and

disposable. Critical features include:

Low TOC

Minimal or no rinse-out needed prior to use

Gamma irradiated and biostable

Endotoxin free

ULTA Pure SG capsulesPleated Capsules with Sterilizing Grade Polyethersulphone

Membranes, ULTA Pure SG utilizes the unique properties of a

patented microbially retentive polyethersulphone membrane

to provide sterile filtration to meet the specific needs of the

pharmaceutical industry.

Features 0.2 micron polyethersulphone membrane

Microbially retentive and validated to ASTM F838-83methodology

Asymmetrical pore structure resulting in highthroughputs and flow rates

Low chemical and protein binding characteristics

Wide range of chemical compatibility with lowextractable levels

ULTA Pure HC capsulesPleated Capsules with Polyethersulphone Membranes, ULTA

Pure HC capsule filters provide sterile filtration and have been

specifically designed for the effective and economical

processing of difficult to filter solutions often associated with

biopharmaceutical and diagnostics production.

Features 0.6/0.2 micron polyethersulphone membrane

Microbially retentive and validated to ASTM F838-83methodology

Optimized membrane configuration allows up to tentimes the throughput

Integral prefilter layer can condense filter trains forgreater processing economy

Fully validated and integrity testable membrane forassurance of sterility

Low adsorption of proteins for minimal loss of

expensive pharmaceutical product

ULTA Prime CG capsulesPleated Capsules with Polyethersulphone Membrane,

ULTA Prime CG filter capsules are specifically designed for

consistently controlling bioburden and particle retention

in a variety of pH ranges and feed streams. The pleated

polyethersulfone (PES) membrane combined with thermal-

bonded construction, in both capsule and cartridge formats,

ensures low extractables and quick flush-up devices.

Features Bioburden control to 5 logs

Broad pH compatibility

High flow, low pressure drop

Exceptional price performance

2 Data File 28-9257-93 AA

Materials of Construction ULTA HC ULTA SG ULTA CG ULTA GF

Filtration membrane Polyethersulphone Polyethersulphone Polyethersulphone Glass Borosilicateglass microfiber

Prefiltration membrane Polyethersulphone N/A Polyester N/A

Upstream support Polyester Polyester Polyester Polyester

Downstream support Polyester Polyester Polyester Polyester

Inner core Polypropylene Polypropylene Polypropylene Polypropylene

Sleeve Polypropylene Polypropylene Polypropylene Polypropylene

Small capsule body (2 in, 4 in, 6 in) Nylon Nylon Nylon Nylon

Large capsule body (5 in, 10 in, 20 in, 30 in) Polypropylene Polypropylene Polypropylene Polypropylene

Capsule vent seals Silicone Silicone Silicone Silicone

Cartridge end caps Nylon Nylon Nylon Nylon

Cartridge end cap insert (5 in, 10 in, 20 in, 30 in) 316 stainless steel 316 stainless steel 316 stainless steel 316 stainless steel

Cartridge 0-rings (5 in, 10 in, 20 in, 30 in) Silicone or EPDM Silicone or EPDM Silicone or EPDM Silicone or EPDM


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ULTA Prime GF capsulesFeatures Micron rating range from 0.6 to 10 micron

High capacity filter media giving microbial retention

Thermal bonded construction

High filtration area

Typical applications Final sterile filtration of biopharmaceutical solutions

Bioburden reduction

Column guard: reducing bioburden and particulatesbefore chromatography columns

Prefiltration of media, buffer, and water

Serum and tissue culture media clarification

Disposable laboratory prefiltration

Biological safetyMaterials conform to the relevant requirements of 21CFR Part

177 and current USP Plastics Class VI - 121C and ISO10993

equivalents.

Non-volatile extractables (NVE)Total NVEs extracted in the first 5 liter flush of WFI for a

10 in equivalent pre-autoclaved device is < 6 mg.

Oxidizable substancesULTA NFF capsule assemblies meet current USP quality

standards for oxidizable substances.

TOC/ConductivityThe effluent quality from a 10 in equivalent ULTA NFF

capsule assemblies conforms to the requirements of USP

28(TOC) and USP 28 (conductivity) following

a 3 liter flush.

EndotoxinsAqueous extracts from the ULTA NFF capsule assemblies

contain < 0.25 Eu/ml when tested in accordance with the

standard LAL test.

Retention characteristicsULTA SG and ULTA HC capsule assemblies are validated

to give an LRV of at least 7 when challenged with

Brevundimonas diminuta in accordance with methods

specified in ASTM F838-05 (107 organisms/cm2 minimum).

Typical in-house challenge levels are in the order of 1011 per

10 in module.

SterilityEach NFF assembly is sterile for all fluid contact surfaces (per

ISO 11137).

Integrity test specifications

All filters are flushed with pharmaceutical grade purifiedwater prior to packaging. They are integrity testable (except

ULTA GF capsules) to the following limits:

Data File 28-9257-93 AA 3

Maximum recommended operating conditions

Large Capsule Assemblies with Readymate (5 in, 10 in, 20 in, 30 in capsules) 5.5 barg (79 psi) at 25C (77F)

Small Capsule Assemblies with Cflex tubing and ReadyMate (2 in, 4 in, 6 in capsules) 1 barg (14.5psi) at 25C (77F)


4/84 Data File 28-9257-93 AA

ULTA filters - Integrity test parametersfor sterile filters and bioburden reduction filters

Pore size IT P Diffusional Flow Specification (sccm) Bubble Point

(microns) (barg) 2-in 4-in 6-in 5-in 10-in 20-in 30-in (barg)

ULTA Prime CG 0.6/0.2 1.70 1.2 2.9 6.0 7.4 16.0 32.0 48.0 2.48

ULTA Pure SG 0.22 2.80 1.2 2.9 6.0 7.4 16.0 32.0 48.0 3.38

ULTA Pure HC 0.6/0.22 2.80 1.4 3.2 6.7 8.4 18.0 36.0 54.0 3.38

Capsule flow rates


5/8Data File 28-9257-93 AA 5

Area specifications/Integrity specifications

ULTA filters - effective filtration areaall values are in square meters (m2)

Pore size Mean Surface Area

(microns) 2-in 4-in 6-in 5-in 10-in 20-in 30-in

ULTA Prime GF 0.6 0.045 0.095 0.19 0.27 0.56 1.12 1.68

1.0 0.045 0.095 0.19 0.24 0.51 1.01 1.52

2.0 0.045 0.095 0.19 0.24 0.51 1.01 1.525.0 0.045 0.095 0.19 0.26 0.53 1.07 1.60

7.0 0.036 0.076 0.15 0.20 0.42 .83 1.25

10.0 0.036 0.076 0.15 0.20 0.42 .83 1.25

ULTA Prime CG 0.6/0.2 0.047 0.10 0.21 0.26 0.55 1.10 1.65

ULTA Pure SG 0.2 0.047 0.10 0.21 0.26 0.55 1.10 1.65

ULTA Pure HC 0.6/0.2 0.047 0.10 0.21 0.26 0.55 1.10 1.65

Ordering informationArticle number Catalog number Description Expanded description

Normal Flow Filter capsule assemblies

12410058 12410058 1XCG9202 2X0.5 FT CF RM ULTA Prime CG 0.2 m 2 in capsule filter and 6 in (152 mm)of C-FLEX 374 tubing terminating with ReadyMate connectors.

12410059 12410059 1XCG9204 2X0.5 FT CF RM ULTA Prime CG 0.2 m 4 in capsule filter and 6 in (152 mm)of C-FLEX 374 tubing terminating with ReadyMate connectors.

12410060 12410060 1XCG92H1 2X RM ULTA Prime CG 0.2 m 5 in capsule filter terminating withReadyMate connectors.

12410061 12410061 1XCG9206 2X0.5 FT CF RM ULTA Prime CG 0.2 m 6 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors.

12410062 12410062 1XCG9210 2X RM ULTA Prime CG 0.2 m 10 in capsule filter terminating withReadyMate connectors.

12410063 12410063 1XCG9220 2X RM ULTA Prime CG 0.2 m 20 in capsule filter terminating withReadyMate connectors.

12410064 12410064 1xCG9230 2x RM ULTA Prime CG 0.2 m 30 in capsule filter terminating withReadyMate connectors.

12410065 12410065 1XGF9602 2X0.5 FT CF RM ULTA Prime GF 0.6 m 2 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors.


12410067 12410067 1XGF96H1 2X RM ULTA Prime GF 0.6 m 5 in capsule filter terminating withReadyMate connectors.


12410069 12410069 1XGF9610 2X RM ULTA Prime GF 0.6 m 10 in capsule filter terminating withReadyMate connectors.



12410072 12410072 1XGF0102 2X0.5 FT CF RM ULTA Prime GF 1 m 2 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors.


6/86 Data File 28-9257-93 AA

Article number Catalog number Description Expanded description

Normal Flow Filter capsule assemblies (continued)


12410074 12410074 1XGF0106 2X0.5 FT CF RM ULTA Prime GF 1 m 5 in capsule filter and of tubingterminating with ReadyMate connectors.

12410075 12410075 1XGF01H1 2X RM ULTA Prime GF 1 m 6 in capsule filter terminating withReadyMate connectors.

12410076 12410076 1XGF0110 2X RM ULTA Prime GF 1 m 10 in capsule filter terminating withReadyMate connectors.









12410085 12410085 1xGF0230 2x RM ULTA Prime GF 2 m 30 in capsule filter terminating withReadyMate connectors.








12410093 12410093 1XHC9202 2X0.5 FT CF RM ULTA Prime HC 0.6/0.2 m 2 in capsule filter and 6 in (152 mm)of C-FLEX 374 tubing terminating with ReadyMate connectors.


12410095 12410095 1XHC92H1 2X RM ULTA Prime HC 0.6/0.2 m 5 in capsule filter terminating withReadyMate connectors.


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Article number Catalog number Description Expanded description

Normal Flow Filter capsule assemblies (continued)


12410097 12410097 1XHC9210 2X RM ULTA Prime HC 0.6/0.2 m 10 in capsule filter terminating withReadyMate connectors.

12410098 12410098 1XHC9220 2X RM ULTA Prime HC 0.6 / 0.2 m 20 in capsule filter terminating withReadyMate connectors.

12410099 12410099 1XHC9230 2X RM ULTA Prime HC 0.6/0.2 m 30 in capsule filter terminating withReadyMate connectors.

12410100 12410100 1XSG9202 2X0.5 FT CF RM ULTA Prime SG 0.2 m 2 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors.


12410102 12410102 1SG92H1 2X RM ULTA Prime SG 0.2 m 5 in capsule filter terminating withReadyMate connectors.


12410104 12410104 1XSG9210 2X RM ULTA Prime SG 0.2 m 10 in capsule filter terminating withReadyMate connectors.



NFF capsule assembliescell harvest filter trains

12410245 12410245 1xGF0502 1xCG9202 2x0.5ft C RM ULTA Prime GF 5 m 2 in capsule filter and ULTA Prime CG0.2 m 2 in capsule filter with 6 in (152 mm) of C-FLEX 374tubing terminating with ReadyMate connectors.

12410246 12410246 1xGF05H1 1xCG9206 1x0.5ft C RM ULTA Prime GF 5 m 5 in capsule filter and ULTA Prime CG0.2 m 6 in capsule filter with 6 in (152 mm) of C-FLEX 374tubing terminating with ReadyMate connectors.

12410247 12410247 1xGF0510 1xCG92H1 2xRM ULTA Prime GF 5 m 10 in capsule filter and ULTA Prime CG0.2 m 5 in capsule filter terminating with ReadyMateconnectors.

12410248 12410248 1xGF0520 1xCG9210 2xRM ULTA Prime GF 5 m 20 in capsule filter and ULTA Prime CG0.2 m 10 in capsule filter terminating with ReadyMateconnectors.

12410251 12410251 1xGF0502 1xHC9202 2x0.5ft C RM ULTA Prime GF 5 m 2 in capsule filter and ULTA Prime HC0.6/0.2 m 2 in capsule filter with 6 in (152 mm) ofC-FLEX 374 tubing terminating with ReadyMate connectors.

12410252 12410252 1xGF05H1 1xHC9206 1x0.5ft C RM ULTA Prime GF 5 m 5 in capsule filter and ULTA Prime HC0.6/0.2 m 6 in capsule filter with 6 in (152 mm) of C-FLEX 374tubing terminating with ReadyMate connectors.

12410253 12410253 1xGF0510 1xHC92H1 2xRM ULTA Prime GF 5 m 10 in capsule filter and ULTA Prime HC0.6/0.2 m 5 in capsule filter terminating with ReadyMate

connectors.12410254 12410254 1xGF0520 1xHC9210 2xRM ULTA Prime GF 5 m 20 in capsule filter and ULTA Prime HC

0.6/0.2 m 10 in capsule filter terminating with ReadyMateconnectors.


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28-9257-93 AB 07/2010

GEHC0093

GE, imagination at work and GE monogram are trademarks of General Electric Company

ReadyToProcess and ULTA are trademarks of GE Healthcare companies.

All third party trademarks are the property of their respective owners.

2010 General Electric Company - All rights reserved. First published Sept. 2007.All goods and services are sold subject to the terms and conditions of sale of the

company within GE Healthcare which supplies them. A copy of these terms and

conditions is available on request. Contact your local GE Healthcare representative

for the most current information.

GE Healthcare UK Ltd Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK

GE Healthcare Bio-Sciences Corp., 800 Centennial Avenue, P.O. Box 1327, Piscataway,

NJ 08855-1327 USA

GE Healthcare Europe, GmbH, Munzinger Strasse 5, D-79111 Freiburg, Germany

GE Healthcare Japan Corporation, Sanken Bldg., 3-25-1, Hyakunincho, Shinjuku-ku, Tokyo

169-0073 Japan

For contact information for your local office,please visit: www.gelifesciences.com/contact

GE Healthcare Bio-Sciences ABBjrkgatan 30751 84 UppsalaSweden

www.gelifesciences.com

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