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

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:

  • Antibodies
  • Protein Solutions
  • Buffers
  • Vaccine concentrates
  • Small Volume Parenterals
Construction
Membrane Hydrophilic PVDF
Final Filter Pore Size
0.2 μm 0.45 μm
Prefilter Pore Size 0.45μm, 0.8μm
Plastic parts Polypropylene
Integrity Testing / Retention
Bubble Point > 50psi (3.51Kg/cm²) with Water
Microbial Retention
LRV >7 for B. diminuta (ATCC 19146) per cm²
LRV >7 for S. marcescens (ATCC 14756) 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 and it cannot 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 (0.45µm Upstream) DWSX
AseptiCap WS (0.8µm* Upstream) DWS5
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
0.2µm 01
0.45µm 02
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

*0.45μm capsule filters are available with 0.8 μm upstream only

**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:

DWSX 53 01
EE
X
X 1 01


Example for Non Sterile: DWSX5301EEXX101          Example for EO Sterile: DWSX5301EEXX201


Datasheet Download
Certificate of Quality Download

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