UA-44035381-1
  • 0.1μm AseptiCap<sup>®</sup> Wl/WS-γ 1", 2", 5", 8"

0.1μm AseptiCap® Wl/WS-γ 1", 2", 5", 8"

mdi 0.1μm AseptiCap® WS-γ are low protein binding hydrophilic PVDF membrane capsule filters, validated to retain mycoplasma, a critical requirement for sterilization of mammalian cell culture media.

These capsules offer serial filtration incorporating a larger pore size upstream membrane to protect the downstream membrane for enhanced throughput.

0.1μm AseptiCap® WS-γ 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
  • Very low hold up volume in filters
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:

  • Cell culture media
  • Growth regulators
  • Small Volume Parenterals
Construction
Membrane Hydrophilic PVDF
Final Filter Pore Size 0.1µm
Prefilter Pore Size 0.2 µm or 0.45 µm
Plastic parts Polypropylene
Size
Size
1" 2" 5" 8"
Effective Filtration Area (Nominal)
250cm² 500cm² 1000cm² 2000cm²
Dimensions (End to End) - 1½" Sanitary Flange I/O
92 mm 112 mm 165 mm 216 mm
Dimension (End to End) - ½" Hose Barb I/O
90 mm 112 mm 162 mm 214 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
-- 112 mm 165 mm 216 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
85 mm104 mm155 mm206 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
-- 115 mm 162 mm 218 mm
Operational Radius (with Vent/ Drain)
40 mm 65 mm 65 mm 65 mm
Vent and Drain
¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only
Integrity Testing / Retention
Bubble Point > 31psi with 50% IPA/Water solution
Microbial Retention LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area
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. Gamma sterilized capsule filters must not be autoclaved or in-line steam sterilized.
Shelf Life 2 years after gamma 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 ISO 11737-1 : 2018
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
DWL (Single Layer) DWLX
DWS (0.2 μm Upstream) DWS1
DWS (0.45 μm 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
0.1µm 36
I/O Connection
Connection Code
¼" SHB A
¼” MNPT (18 TPI) B
¼” BSP (19 TPI) M
¼” BSP (19 TPI) with O-ring P
¼” BSP F
½” MNPT C
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
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 sterile capsule filters cannot be gamma irradiated again.

Example:

DWSX 53 36 QQ R X 1 01


Example for Non Sterile: DWSX5336QQRX101          Example for Gamma Sterile: DWSX5336QQXX301

Datasheet Download

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