UA-44035381-1
  • AseptiCap WS 25mm, 50mm

AseptiCap WS 25mm, 50mm

mdi AseptiCap WS are low protein binding hydrophilic PVDF gamma sterilizable membrane inline capsule filters, designed for sterile filtration of very small fluid volumes in formulation and process development labs.

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

Sterile Filtration of:

  • Antibodies
  • Protein Solutions
  • Buffers
  • Heat labile additives
  • Vaccine concentrates
  • Small Volume Parenterals
Construction
Membrane 0.2 µm Hydrophilic PVDF
Prefilter Membrane 0.45 µm Hydrophilic PVDF
Plastic parts Polypropylene
Integrity Testing / Retention
Bubble Point > 50psi (3.52 Kg/cm²) with Water
Microbial Retention LRV>7 for Brevundimonas diminuta (ATCC 19146) per cm²
Size
Size
25 mm 50 mm
Effective Filtration Area (Nominal)
5 cm²20 cm²
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip
23 mm --
Dimension (End to End) - ¼" SHB
-- 79 mm
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O
-- 51 mm
Operational Radius (with Vent/ Drain)
15 mm 28 mm
Operational
Max. Operating Temperature
55 °C 60 °C
Max. Differential Pressure
75 Psi (5 Kg/cm²)@ 25 °C42 Psi (3 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 All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 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

AseptiCap WS (25mm)

Type
AseptiCap WS
(0.45μm Upstream)
IWSX
Size
Dia Code
25mm 06
Pore Size
Pore Size Code
0.2µm 01
Inlet
Connection Code
⅛" Hose Barb
H
¼" Hose Barb B
Female Luer lock M
Outlet
Connection Code
⅛" Hose Barb
H
¼" Hose Barb B
Male Luer Slip N
Male Luer lock L
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
100 04

Example:

IWSX 06 01
M N X X 1 04
Example for Non Sterile: IWSX0601MNXX104          Example for EO Sterile: IWSX0601MNXX204

AseptiCap WS (50mm)

Type
AseptiCap WS
(0.45 μm Upstream)
IWSX
Vented AseptiCap WS
(0.45 μm Upstream)
VWSX
Size
Dia Code
50mm 10
Pore Size
Pore Size Code
0.2µm 01
Inlet
Connection Code
¼" Stepped Hose Barb B
¾" Sanitary Flange S
Outlet
Connection Code
¼" Stepped Hose Barb B
¾" Sanitary Flange* S
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
10 02
100 04

* In vented AseptiCap WS ¾” Sanitary Flange is available as outlet only

Example:

IWSX 10 01
SS X
X 1 04
Example for Non Sterile: IWSX1001SSXX104          Example for EO Sterile: IWSX1001SSXX204
Datasheet Download
Certificate of Quality Download

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