GE Healthcare

Data file 28-9257-93 AB Filtration

ReadyToProcess ULTA Normal Flow Filter capsules and assemblies

GE 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 capsules are 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.

Fig 1. ReadyToProcess NFF capsule filter attached to ReadyCircuit bag

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

ReadyToProcess
ReadyToProcess is a suite of products that is designed to bring a comprehensive offering of ready to process disposables such as:

Cross flow filters (CFF) Normal flow filters (NFF) Pre-packed Chromatography columns

Decrease risk of process cross-contamination Simplify and speed bioprocessing Reduce process development time in bioprocess operations Lower capital investment/increase cash flow

Features and benefits and materials of construction

Preconditioned: NFF capsule filters are preconditioned at the factory, so the NFF capsule assemblies are ready to use and disposable. Critical features include:

ULTA Pure HC capsules

Pleated 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.

Low TOC Minimal or no rinse-out needed prior to use Gamma irradiated and biostable Endotoxin free

Features
0.6/0.2 micron polyethersulphone membrane Microbially retentive and validated to ASTM F838-83 methodology Optimized membrane configuration allows up to ten times the throughput Integral prefilter layer can condense filter trains for greater processing economy Fully validated and integrity testable membrane for assurance of sterility Low adsorption of proteins for minimal loss of expensive pharmaceutical product

ULTA Pure SG capsules

Pleated 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 F838-83 methodology Asymmetrical pore structure resulting in high throughputs and flow rates Low chemical and protein binding characteristics Wide range of chemical compatibility with low extractable levels

ULTA Prime CG capsules

Pleated 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 thermalbonded 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

Materials of Construction
Filtration membrane Prefiltration membrane Upstream support Downstream support Inner core Sleeve Small capsule body (2 in, 4 in, 6 in) Large capsule body (5 in, 10 in, 20 in, 30 in) Capsule vent seals Cartridge end caps Cartridge end cap insert (5 in, 10 in, 20 in, 30 in) Cartridge 0-rings (5 in, 10 in, 20 in, 30 in)

ULTA HC
Polyethersulphone Polyethersulphone Polyester Polyester Polypropylene Polypropylene Nylon Polypropylene Silicone Nylon 316 stainless steel Silicone or EPDM

ULTA SG
Polyethersulphone N/A Polyester Polyester Polypropylene Polypropylene Nylon Polypropylene Silicone Nylon 316 stainless steel Silicone or EPDM

ULTA CG
Polyethersulphone Polyester Polyester Polyester Polypropylene Polypropylene Nylon Polypropylene Silicone Nylon 316 stainless steel Silicone or EPDM

ULTA GF
Glass Borosilicate glass microfiber N/A Polyester Polyester Polypropylene Polypropylene Nylon Polypropylene Silicone Nylon 316 stainless steel Silicone or EPDM

Data File 28-9257-93 AA

ULTA Prime GF capsules

Features
Micron rating range from 0.6 to 10 micron High capacity filter media giving microbial retention Thermal bonded construction High filtration area

Oxidizable substances
ULTA NFF capsule assemblies meet current USP quality standards for oxidizable substances.

TOC/Conductivity
The effluent quality from a 10 in equivalent ULTA NFF capsule assemblies conforms to the requirements of USP 28<643>(TOC) and USP 28<645> (conductivity) following a 3 liter flush.

Typical applications
Final sterile filtration of biopharmaceutical solutions Bioburden reduction Column guard: reducing bioburden and particulates before chromatography columns Prefiltration of media, buffer, and water Serum and tissue culture media clarification Disposable laboratory prefiltration

Endotoxins
Aqueous extracts from the ULTA NFF capsule assemblies contain < 0.25 Eu/ml when tested in accordance with the standard LAL test.

Retention characteristics
ULTA 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.

Biological safety
Materials 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.

Sterility
Each NFF assembly is sterile for all fluid contact surfaces (per ISO 11137).

Integrity test specifications

All filters are flushed with pharmaceutical grade purified water prior to packaging. They are integrity testable (except ULTA GF capsules) to the following limits:

Maximum recommended operating conditions

Large Capsule Assemblies with Readymate (5 in, 10 in, 20 in, 30 in capsules) Small Capsule Assemblies with Cflex tubing and ReadyMate (2 in, 4 in, 6 in capsules) 5.5 barg (79 psi) at 25C (77F) 1 barg (14.5psi) at 25C (77F)

Data File 28-9257-93 AA

ULTA filters - Integrity test parameters

for sterile filters and bioburden reduction filters
Pore size (microns) IT P (barg) 2-in 4-in Diffusional Flow Specification (sccm) 6-in 5-in 10-in 20-in 30-in Bubble Point (barg)

ULTA Prime CG ULTA Pure SG ULTA Pure HC

0.6/0.2 0.22 0.6/0.22

1.70 2.80 2.80

1.2 1.2 1.4

2.9 2.9 3.2

6.0 6.0 6.7

7.4 7.4 8.4

16.0 16.0 18.0

32.0 32.0 36.0

48.0 48.0 54.0

2.48 3.38 3.38

Capsule flow rates

Data File 28-9257-93 AA

Area specifications/Integrity specifications

ULTA filters - effective filtration area
all values are in square meters (m2)
Pore size (microns) 2-in 4-in 6-in Mean Surface Area 5-in 10-in 20-in 30-in

ULTA Prime GF

0.6 1.0 2.0 5.0 7.0 10.0

0.045 0.045 0.045 0.045 0.036 0.036 0.047 0.047 0.047

0.095 0.095 0.095 0.095 0.076 0.076 0.10 0.10 0.10

0.19 0.19 0.19 0.19 0.15 0.15 0.21 0.21 0.21

0.27 0.24 0.24 0.26 0.20 0.20 0.26 0.26 0.26

0.56 0.51 0.51 0.53 0.42 0.42 0.55 0.55 0.55

1.12 1.01 1.01 1.07 .83 .83 1.10 1.10 1.10

1.68 1.52 1.52 1.60 1.25 1.25 1.65 1.65 1.65

ULTA Prime CG ULTA Pure SG ULTA Pure HC

0.6/0.2 0.2 0.6/0.2

Ordering information
Article number 12410058 12410059 12410060 12410061 12410062 12410063 12410064 12410065 12410066 12410067 12410068 12410069 12410070 12410071 12410072 Catalog number 12410058 12410059 12410060 12410061 12410062 12410063 12410064 12410065 12410066 12410067 12410068 12410069 12410070 12410071 12410072 Description 1XCG9202 2X0.5 FT CF RM 1XCG9204 2X0.5 FT CF RM 1XCG92H1 2X RM 1XCG9206 2X0.5 FT CF RM 1XCG9210 2X RM 1XCG9220 2X RM 1xCG9230 2x RM 1XGF9602 2X0.5 FT CF RM 1XGF9604 2X0.5 FT CF RM 1XGF96H1 2X RM 1XGF9606 2X0.5 FT CF RM 1XGF9610 2X RM 1XGF9620 2X RM 1XGF9630 2X RM 1XGF0102 2X0.5 FT CF RM Expanded description ULTA Prime CG 0.2 m 2 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime CG 0.2 m 4 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime CG 0.2 m 5 in capsule filter terminating with ReadyMate connectors. ULTA Prime CG 0.2 m 6 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime CG 0.2 m 10 in capsule filter terminating with ReadyMate connectors. ULTA Prime CG 0.2 m 20 in capsule filter terminating with ReadyMate connectors. ULTA Prime CG 0.2 m 30 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 0.6 m 2 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 0.6 m 4 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 0.6 m 5 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 0.6 m 6 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 0.6 m 10 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 0.6 m 20 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 0.6 m 30 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 1 m 2 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors.

Normal Flow Filter capsule assemblies

Data File 28-9257-93 AA

Article number 12410073 12410074 12410075 12410076 12410077 12410078 12410079 12410080 12410081 12410082 12410083 12410084 12410085 12410086 12410087 12410088 12410089 12410090 12410091 12410092 12410093 12410094 12410095

Catalog number 12410073 12410074 12410075 12410076 12410077 12410078 12410079 12410080 12410081 12410082 12410083 12410084 12410085 12410086 12410087 12410088 12410089 12410090 12410091 12410092 12410093 12410094 12410095

Description 1XGF0104 2X0.5 FT CF RM 1XGF0106 2X0.5 FT CF RM 1XGF01H1 2X RM 1XGF0110 2X RM 1XGF0120 2X RM 1XGF0130 2X RM 1XGF0202 2X0.5 FT CF RM 1XGF0204 2X0.5 FT CF RM 1XGF0206 2X0.5 FT CF RM 1XGF02H1 2X RM 1XGF0210 2X RM 1XGF0220 2X RM 1xGF0230 2x RM 1XGF0502 2X0.5 FT CF RM 1XGF0504 2X0.5 FT CF RM 1XGF05H1 2X RM 1XGF0506 2X0.5 FT CF RM 1XGF0510 2X RM 1XGF0520 2X RM 1XGF0530 2X RM 1XHC9202 2X0.5 FT CF RM 1XHC9204 2X0.5 FT CF RM 1XHC92H1 2X RM

Expanded description ULTA Prime GF 1 m 4 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 1 m 5 in capsule filter and of tubing terminating with ReadyMate connectors. ULTA Prime GF 1 m 6 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 1 m 10 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 1 m 20 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 1 m 30 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 2 m 2 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 2 m 4 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 2 m 5 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 2 m 6 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 2 m 10 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 2 m 20 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 2 m 30 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 5 m 2 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 5 m 4 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 5 m 5 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 5 m 6 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 5 m 10 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 5 m 20 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 5 m 30 in capsule filter terminating with ReadyMate connectors. 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. ULTA Prime HC 0.6/0.2 m 4 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime HC 0.6/0.2 m 5 in capsule filter terminating with ReadyMate connectors.

Normal Flow Filter capsule assemblies (continued)

Data File 28-9257-93 AA

Article number 12410096 12410097 12410098 12410099 12410100 12410101 12410102 12410103 12410104 12410105 12410106

Catalog number 12410096 12410097 12410098 12410099 12410100 12410101 12410102 12410103 12410104 12410105 12410106

Description 1XHC9206 2X0.5 FT CF RM 1XHC9210 2X RM 1XHC9220 2X RM 1XHC9230 2X RM 1XSG9202 2X0.5 FT CF RM 1XSG9204 2X0.5 FT CF RM 1SG92H1 2X RM 1XSG9206 2X0.5 FT CF RM 1XSG9210 2X RM 1XSG9220 2X RM 1XSG9230 2X RM

Expanded description ULTA Prime HC 0.6/0.2 m 6 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime HC 0.6/0.2 m 10 in capsule filter terminating with ReadyMate connectors. ULTA Prime HC 0.6 / 0.2 m 20 in capsule filter terminating with ReadyMate connectors. ULTA Prime HC 0.6/0.2 m 30 in capsule filter terminating with ReadyMate connectors. ULTA Prime SG 0.2 m 2 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime SG 0.2 m 4 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime SG 0.2 m 5 in capsule filter terminating with ReadyMate connectors. ULTA Prime SG 0.2 m 6 in capsule filter and 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime SG 0.2 m 10 in capsule filter terminating with ReadyMate connectors. ULTA Prime SG 0.2 m 20 in capsule filter terminating with ReadyMate connectors. ULTA Prime SG 0.2 m 30 in capsule filter terminating with ReadyMate connectors.

Normal Flow Filter capsule assemblies (continued)

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 CG 0.2 m 2 in capsule filter with 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 5 m 5 in capsule filter and ULTA Prime CG 0.2 m 6 in capsule filter with 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 5 m 10 in capsule filter and ULTA Prime CG 0.2 m 5 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 5 m 20 in capsule filter and ULTA Prime CG 0.2 m 10 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 5 m 2 in capsule filter and ULTA Prime HC 0.6/0.2 m 2 in capsule filter with 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 5 m 5 in capsule filter and ULTA Prime HC 0.6/0.2 m 6 in capsule filter with 6 in (152 mm) of C-FLEX 374 tubing terminating with ReadyMate connectors. ULTA Prime GF 5 m 10 in capsule filter and ULTA Prime HC 0.6/0.2 m 5 in capsule filter terminating with ReadyMate connectors. ULTA Prime GF 5 m 20 in capsule filter and ULTA Prime HC 0.6/0.2 m 10 in capsule filter terminating with ReadyMate connectors.

12410246

12410246

1xGF05H1 1xCG9206 1x0.5ft C RM

12410247

12410247

1xGF0510 1xCG92H1 2xRM

12410248

12410248

1xGF0520 1xCG9210 2xRM

12410251

12410251

1xGF0502 1xHC9202 2x0.5ft C RM

12410252

12410252

1xGF05H1 1xHC9206 1x0.5ft C RM

12410253

12410253

1xGF0510 1xHC92H1 2xRM

12410254

12410254

1xGF0520 1xHC9210 2xRM

For contact information for your local office, please visit: www.gelifesciences.com/contact GE Healthcare Bio-Sciences AB Bjrkgatan 30 751 84 Uppsala Sweden www.gelifesciences.com

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

28-9257-93 AB 07/2010 GEHC0093