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

AseptiCap WS-γ 1", 2", 5", 8"

mdi AseptiCap WS-γ are low protein binding hydrophilic PVDF gamma sterilizable membrane capsule filters offering serial filtration incorporating a larger 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 hold up volume
Consistent and Reliable Quality:
AseptiCap capsule filters are produced with ISO 9001 certified quality management systems.
Regulatory Compliance:
Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554
Low Protein Binding:
Results in increased overall product yield.
High Throughputs:
Translates to lower filtration costs, less number of filter changes and overall economy of operations.
Low Extractables:
Mean less addition to impurity profile of the biological product from the filters.

Sterile Filtration of :

  • Antibodies
  • Protein Solutions
  • Buffers
  • Vaccine concentrates
  • Small Volume Parenterals
Construction
Membrane Hydrophilic PVDF
Final Filter Pore Size 0.2μm
Prefilter Pore Size 0.45μm
Support Layers Polyester
Plastic parts Polypropylene
Integrity Testing / Retention
Bubble Point > 50 psi (3.51 Kg/cm² ) with Water
Microbial Retention LRV >7 for Brevundimonas diminuta (ATCC 19146) 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 mm110 mm161 mm211 mm
Dimension (End to End) - ½" Hose Barb I/O
90 mm112 mm164 mm215 mm
Dimension (End to End) - ¼" SHB I/O
94 mm
122 mm172 mm223 mm
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O
91 mm103 mm155 mm205 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
-- 115 mm 165 mm 217 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
--111 mm162 mm212 mm
Operational Radius (with Vent/ Drain)
30 mm65 mm65 mm65 mm
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure 60 psi (4 Kg/cm²) @ 30 °C
Sterilization By Irradiation

Gamma Irradiatiable up to 50 kGy

Shelf Life 2 years after Gamma Sterilization
Hold-up Volume
< 5ml < 25ml < 45ml < 60ml
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 3 liter 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-γ
(0.45μm Upstream)
DWSX
Size
Length and EFA Code
1" (100 cm²) 31
1" (250 cm²) 51
2" (500 cm²) 52
5" (1000 cm²) 53
8" (2000 cm²) 57
Pore Size
Pore Size Code
0.2µm 01
I/O Connection
Connection Code
¼" SHB A
½” Hose Barb D
1½" Sanitary Flange E
¾" Sanitary Flange S
Quick Connector J
½” Single Step Hose Barb*
Q
Female Luer Lock U
Male Luer Slip** W
3/8" Hose Barb* I
3/16" Hose Barb*** N
Radiation Sterilizable
Code
Yes R
No**** X
X
Sterility
Code
Non Sterile 1
Gamma Sterile 3
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

****Gamma irradiated capsule filters cannot be gamma sterilized again


Example:

DWSX 53 01 QQ
R X 1 01

Example for Non Sterile: DWSX5301QQRX101               Example for Gamma Sterile: DWSX5301QQXX301


Datasheet Download
Certificate of Quality Download

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