206958 DF_RTP_NFF

GE Healthcare
Data file 28-9257-93 AB
Filtration
ReadyToProcess
Normal Flow Capsule Filters
ReadyToProcess Normal Flow Capsules are single-use filters
designed for laboratory through process scale applications,
with typical volumes ranging from a few mls to thousands of
liters of solution.
ReadyToProcess NFF Capsules Offered:
RTP ULTA Pure SG capsule: provides sterilizing grade filtration
of biopharmaceutical solutions
RTP ULTA Pure HC capsule: provides sterilizing grade filtration
of difficult-to-filter biopharmaceutical solutions
ReadyToProcess
ReadyToProcess Normal Flow Capsules are part of a suite of
products that are designed to bring a comprehensive offering
of ready to use cell culture, purification, and fluid
management products such as:
• Cross flow filters (CFF)
• Normal flow filters (NFF)
• Chromatography columns
• Bio-reactors
• Mixers
• Aseptic tube sealers/connectors
Use of ReadyToProcess products and technology will
• Decrease risk of process cross-contamination
• Simplify and speed bioprocessing
Figure 1. ReadyToProcess Normal Flow Capsule filters
ReadyToProcess
Normal Flow Capsules are:
Preconditioned
• Manufactured to provide low TOC and conductivity
levels, allowing you to start your process steps faster
Prepared
• Processed to minimize endotoxin levels and exposed
to gamma radiation enhancing the overall biosafety of
your process
Preferred
• Allow you to maximize process optimization
and throughput
• Reduce process development time in
bioprocess operations
• Lower capital investment / increase cash flow

RTP ULTA Pure SG capsules
Pleated Capsules with Sterilizing Grade Polyethersulphone
Membranes RTP ULTA Pure SG capsule utilizes the
special properties of a patented microbially retentive
polyethersulphone membrane to provide sterile filtration
to meet the specific needs of the pharmaceutical industry.
Features
• Gamma compatible
• Microbially retentive and validated to ASTM F838-83
methodology
• Asymmetrical pore structure resulting in high throughputs
and flow rates
• Low protein binding characteristics
• Wide range of chemical compatibility with low
extractable levels
Materials of construction
• Polyethersulphone membrane
• Polyester support layers
• Nylon housing and components: cage and core
• Nylon end caps
RTP ULTA Pure HC capsules
Pleated Capsules with Polyethersulphone Membranes
RTP ULTA Pure HC capsule filters have been specifically
designed for the effective and economical processing
of difficult to filter solutions often associated with
biopharmaceutical production.
Features
• Optimized membrane configuration allows up to ten
times the throughput
• Integral prefilter layer minimizes areas for greater
processing economy
• Correlated integrity test assures sterility
• Low adsorption of proteins for minimal loss of expensive
pharmaceutical product
Materials of construction
• Polyethersulphone membrane over
Polyethersulphone prefilter layer
• Polyester support layers
• Nylon housing and components: cage and core
• Nylon end caps
Recommended capsule
operating conditions
Up to 70°C (158°F) continuous operating temperature
and higher short-term temperatures:
Maximum
Maximum
Temperature forward dp reverse dp (1)
(ºC) (bar) (psi) (bar) (psi)
20 5.0 72 2.0 29
40 4.0 58 1.5 22
60 3.0 44 1.0 15
80 2.0 29 0.5 7
90 1.0 15 not recommended
Capsules may be operated up to a temperature of 40°C (104°F) at line
pressures up to 5.0 bar (72 psig) for liquids and 4.0 bar (58 psi) in air/gas
Biological safety
Materials conform to the relevant requirements of 21CFR
Part 177 and current USP Plastics Class VI - 121°C and
ISO10993 equivalents.
Non-volatile extractables (NVE)
Total NVE’s extracted in the first five liter flush of WFI for
a 6 inch equivalent gamma sterilized device is < 5 mg.
Oxidizable substances
RTP ULTA Pure HC and SG capsule products meet current
USP quality standards for oxidizable substances.
TOC/Conductivity
The effluent quality from a 6 inch equivalent RTP ULTA Pure
HC and SG capsule device conforms to the requirements of
USP 28(TOC) and USP 28 (conductivity) following
a three liter flush.
Endotoxins
Aqueous extracts from the RTP ULTA Pure HC and SG capsule
products contain < 0.125 Eu/ml when tested in accordance
with the standard LAL test.
Retention characteristics
RTP ULTA Pure SG and RTP ULTA Pure HC capsules are
validated to give an LRV of at least 7 when challenged with
Brevundimonas diminuta in accordance with methods
specified in ASTM F838-05 (10 7 organisms / cm 2 minimum).
2 Data File 28-9257-93 AB

Area Specifications/Integrity
Specifications
All filters are flushed with pharmaceutical grade purified
water prior to packaging.
Product Name 6" Capsule 4" Capsule 2" Capsule Water Wet Bubble
Point Integrity Spec
RTP ULTA Pure SG capsule 0.22m 2 (2.3 ft 2 ) 0.11m 2 (1.2 ft 2 ) 0.05m 2 (2.3 ft 2 ) 3.4 barg (49 psig)
Diffusion Specification 6.1 mL/min @ 2.8 barg 3.0 mL/min @ 2.8 barg 1.4 mL/min @ 2.8 barg
w/Water Wet Filter (40.6 psig) @ 20°C (40.6 psig) @ 20°C (40.6 psig) @ 20°C
RTP ULTA Pure HC capsule 0.22m 2 (2.3 ft 2 ) 0.11m 2 (1.2 ft 2 ) 0.05m 2 (2.3 ft 2 ) 3.4 barg (49 psig)
Diffusion Specification 6.1 mL/min @ 2.8 barg 3.0 mL/min @ 2.8 barg 1.4 mL/min @ 2.8 barg
w/Water Wet Filter (40.6 psig) @ 20°C (40.6 psig) @ 20°C (40.6 psig) @ 20°C
Capsule Flow Rates - RTP ULTA Pure SG capsule
Differential Pressure (mbar)
900
800 4” Size
13
12
700
600
11
10
9
0.2μm 8
500
400
7
6
5
300
200
4
3
100
0
for liquid at 1cp @ 20˚C
2
1
0
0 2 4 6 8 10
Flow (l/min)
Differential Pressure (psi)
Key to Capsule Catalog Numbers
Capsules
Device Type Media Type Special Detail Special Micron Rating Size Size
End Fittings
Inlet Outlet
Digit 1 2 3 4 5 6 7 8 9 10 11 12
K = Capsule
M P H
S
G
H
C
9 2
02 = 2”
04 = 4”
06 = 6”
T = 1.5” TC
H = 1/2” HB
H = 1/2” HB
H = 1/2” HB
Example: RTP ULTA Pure SG capsule, Triclamp 1 1/2" inlet, 1/2" Hose barb outlet
KMPHSG9204TH
Data File 28-9257-93 AB 3

For contact information for your local office,
please visit: www.gelifesciences.com/contact
GE Healthcare Bio-Sciences AB
Björkgatan 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.
© 2009 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 Bio-Sciences KK, Sanken Bldg., 3-25-1, Hyakunincho, Shinjuku-ku, Tokyo
169-0073 Japan
28-9257-93 AB 01/2009