UA-44035381-1
  • 0.1μm AseptiCap WS 1", 2", 5", 8"

0.1μm AseptiCap WS 1", 2", 5", 8"

mdi AseptiCap WS are low protein binding hydrophilic PVDF membrane capsule filters offering serial filtration incorporating a large pore size upstream membrane to protect the downstream membrane for enhanced throughput.

These capsule filters are validated to meet compendia and regulatory requirements and are well characterized. They meet key process requirements such as absolute retention efficiency, extremely low extractables, high throughputs, wide chemical compatibility and other important characteristics.

  • Absolute retention
  • 100% integrity tested
  • Low protein binding
  • Low extractables
  • Very low hold up volume in filters

Sterile Filtration of:

  • Cell culture media
  • Growth regulators
  • Small Volume Parenterals
Construction
Membrane Hydrophilic PVDF
Final Filter Pore Size 0.1 μm
Prefilter Pore Size 0.2 μm
Plastic parts Polypropylene
Integrity Testing / Retention
Bubble Point > 31psi with 50% IPA/Water solution
Microbial Retention LRV>7 for A.laidlawii (ATCC 23206) per cm²
Size
Size
1" 2" 5" 8"
Effective Filtration Area (Nominal)
250cm² 500cm² 1000cm² 2000cm²
Dimensions (End to End) - 1½" Sanitary Flange I/O
91 mm 110 mm 161 mm 211 mm
Dimension (End to End) - ½" Hose Barb I/O
90 mm 112 mm 164 mm 215 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
-- 111 mm 162 mm 212 mm
Dimension (End to End) - ¼" SHB I/O
92 mm 122 mm 172 mm 223 mm
Dimensions (End to End) - ¾" Sanitary Flange I/O
91 mm103 mm155 mm205 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
-- 115 mm 165 mm 217 mm
Operational Radius (with Vent/ Drain)
30 mm 65 mm 65 mm 65 mm
Vent and Drain
¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure 60 psi (4 Kg/cm²) @ 30 °C
Sterilization By Gas Sterilization by Ethylene Oxide
Sterilization By Autoclave Autoclavable at 125°C for 30 minutes, 2 Cycles. Can not be in-line steam sterilized
Shelf Life 3 years after EO sterilization
Assurance
Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics
Cytotoxicity Passes Biological Reactivity Tests, In Vitro, USP <87> for cytotoxicity
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test
Bioburden Bioburden level is < 1000 cfu/filter device as per ANSI/AAMI/ISO 11737-1 : 1995
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
TOC and Conductivity Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a specified minimal flush
Indirect Food Additive Comply with USFDA 21 CFR Part 177.1520
Extractables with WFI Passes test as per USP
Oxidizable Substances Within limits as specified in USP
Particle Shedding Passes USP test for particulates in injectables
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Type
AseptiCap WS (0.2µm Upstream) DWS1
AseptiCap WS (0.45µm Upstream) DWSX
Size
Length and EFA Code
1" (250 cm²) 51
2" (500 cm²) 52
5" (1000 cm²) 53
8" (2000 cm²) 57
Pore Size
Pore Size Code
0.1µm 36
Inlet/Outlet
Connection Code
¼" SHB A
½” Hose Barb D
1½" Sanitary Flange E
¾" Sanitary Flange S
Quick Connector J
Single Step ½” Hose Barb* Q
Female Luer Lock U
Male Luer Slip** W
3/8" Hose Barb* I
3/16" Hose Barb*** N
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
1 01

*1” Capsule Filters are not available with ½” Single step Hose Barb and 3/8" Hose Barb

**Male luer slip is available only in 1” capsule filter as outlet

***3/16" Hose Barb end connection is available in:

  • 1" and 2" capsule filters as inlet and outlet
  • 5" capsule filters as outlet only

Example:

DWS1 53 36 EE
X
X 1 01


Example for Non Sterile: DWS15336EEXX101          Example for EO Sterile: DWS15336EEXX201

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