Description Specifications Autoclave/Steaming Materials

Element Data Sheet E70
SuporLife® 200 Cartridge Filters
Description
Specifications
SUPORLIFE 200 cartridges are validated,
sterilizing-grade filters featuring two
layers of SUPOR® polyethersulfone
membrane with an upstream 0.8 µm
layer for prefiltration and protection of the
downstream 0.2 µm sterilizing grade
layer. SUPORLIFE media is low preservative and protein binding and can provide
higher flow rates and longer life with
biological solutions.
Materials
Autoclave/Steaming
• Membrane: serial layers of SUPOR
polyethersulfone membrane
• Support materials and structural
components: polypropylene
• O-ring: Silicone 1
Autoclave:
• 2.5 hrs (30 minute liquid cycles) at
250°F (121°C)
In situ Steam:
• 5 hrs (1 hour cycles) at 288°F (142°C)
• 0.2 µm sterilizing grade
• Built-in prefilter layer
• Thermal bonded construction
eliminates adhesive extractables
• Meets USP Biological Reactivity for
Class VI-121°C plastics
• Integrity testable
• Sterilizable by autoclave or in-situ
steam
• Manufactured for use in compliance
with GMP
• Manufacturing Quality System Certified
to ISO 9000 Standards
• Validation Guide available
Applications
• Sterile filtration of pharmaceuticals,
biologicals, serum, buffers, media
• Pharmaceutical product additives,
bulk products and intermediates
• Recombinant proteins
• Water
• Fermentation feed stocks
Microbial Removal Ratings
5
Aqueous Extractables (NVR)
2
6
• Typically <34 mg per 10 in.
(254 mm) element
• 0.2 µm sterilizing grade (Liquid)
Filter Area (nominal)
Per 10 in. (254 mm) Element:
• 5.0 ft2 (4650 cm2)
Dimensions (nominal)
• Lengths: 5" (12.7 cm), 10" (25.4 cm),
20″ (50.8 cm), 30" (76.2 cm),
40" (101.6 cm)
• Diameters: 2.7" (6.9 cm) 2.9" (7.4 cm)
Configuration (Code 7)
3
• Double 226 O-ring adapter
• Finned end, bayonet lock
Typical Operating Conditions
4
Maximum Differential Pressure/Temp.:
• 60 psid (4.1 bar) at ambient
temperature
• 30 psid (2.1 bar) at 185°F (85°C)
Maximum Differential Pressure/
Temperature (Reverse):
• 15 psid (1 bar) at ambient temperature
1
2
3
4
5
6
© Copyright 2000 by Pall Corporation. All rights reserved.
Other polymers available.
Lot samples retain >10 7 cfu/cm 2 of
Brevundimonas diminuta per mod. ASTM F838-83
and FDA guidelines.
Alternate adapter codes available.
Using compatible fluids.
Cartridge adapters with encapsulated support
rings are recommended to be used in elevated
temperature applications or when heat sterilization
is being used. Lab tests to establish multi-cycle
resistance. Filters should be qualified in actual use.
Contact Pall for recommended procedures.
In water at 74°F (20°C), after autoclaving.
Quality/Bio-safety
Recommended Integrity Test
Integrity (100% Unit Release Test)
• Correlated to microbial retention
Biological Tests:
• Meets USP Biological Reactivity, In Vivo, for Class VI-121°C
plastics
Effluent Quality Tests 7
• Meets Cleanliness per USP Particulates in Injectables
• Non-Fiber-Releasing per 21 CFR
• Non-Pyrogenic per USP Bacterial Endotoxins (<0.25 EU/ml)
• Meets USP limits for TOC and Conductivity under Purified
Water after flushing
• Meets USP limits for pH under Packaged Water after flushing
Steam Resistance: Lot samples multi-cycle autoclave challenged
Max. Forward Flow limit (Air test gas, water wet)
• ≤15 cc/min at 45 psig (3.1 bar)
Minimum Bubble Point
• 51 psig (3.1 bar), water wet
Typical Liquid Flow Rate (at 1 cp)
• 1.8 gpm/psid/10" length (9.9 lpm/0.1 bar/25.4 cm)
7
Per lot sample soak or rinse-up flush aliquots.
Part Numbers/Ordering Information
Part
Number*
8
SCS92DP7*S
Length
Code*
Removal
Rating
1, 2, 3, or 4
0.2 µm
* Select Length Code: 1 = 10" (25.4 cm), 2 = 20" (50.8 cm), 3 = 30" (76.2 cm),
4 = 40" (101.6 cm).
8
Code 7 (226/Fin/SS) adapter is standard. Alternate configurations: Code 5 is
222/Flat/SS (= Pall Code 3), Code 6 is 222/Fin/SS (= Pall Code 8);
SS indicates steamable with encapsulated support ring.
S suffix = Silicone O-rings (standard).
Note: For sizing or other information, contact your local Pall distributor.
Specifications and availability: The information provided is a guide to the part
number structure and possible options. Product availability may be subject to
change without notice. All specifications are nominal. This literature was reviewed
for accuracy at the time of publication. For current information on the products
and test methodologies, consult your local Pall distributor.
2200 Northern Boulevard
East Hills, New York 11548-1289
Visit us on the Web at www.pall.com/biopharmaceuticals
800.717.7255 toll free
516.484.5400 phone
516.625.3610 fax
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week. Call 1.516.942.0523 from outside the USA.
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major industrial areas of the world.
© Copyright 2000, Pall Corporation. Pall,
, SuporLife, Supor are trademarks of Pall Corporation. ® Indicates a Pall
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© Copyright 2000 by Pall Corporation. All rights reserved.