UA-44035381-1
  • 0.1μm AseptiCap WS-γ 5", 10", 20", 30"

0.1μm AseptiCap WS-γ 5", 10", 20", 30"

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 large 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
  • 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:

  • Cell culture media
  • Growth regulators
  • Small Volume Parenterals
Construction
Membrane Hydrophilic PVDF
Pore size 0.1 µm
Prefilter Pore Size 0.2µm,0.45µm
Support Layers Polyester
Plastic parts Polypropylene
Body and Core Gamma Stable Polypropylene
Integrity Testing / Retention
Microbial Retention LRV >7 for Acholeplasma laidlawii (ATCC 23206) per cm²
Bubble Point (with 50% IPA) > 31psi
Size
Size
5" 10" 20" 30"
Effective Filtration Area
3000 cm²6000 cm²12000 cm²18000 cm²
Dimensions (End to End) - 1½" Sanitary Flange I/O
207 mm 326 mm 605 mm 865 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet
203 mm
332 mm
618 mm
878 mm
Dimension (End to End) - ¾" Sanitary Flange I/O
212 mm 345 mm -- --
Dimension (End to End) - ½" Single Step Hose Barb I/O
217 mm 332 mm 628 mm 888 mm
Dimension (End to End) - 1" Hose Barb I/O
-- 405 mm 635 mm 895 mm
Operational Radius (with Vent/ Drain)
78 mm 78 mm 78 mm 78 mm
Dimension (End to End) - 3/8" Hose Barb I/O
211 mm 330 mm 618 mm 878 mm
Vent and Drain ¼" Hose Barb with Silicone "O" ring
Operational
Max. Operating Temperature 80°C @ < 2Kg/cm² (30 psi)
Max. Differential Pressure < 4 Kg/cm² (60 psi) @ 30° C
Sterilization By Irradiation Gamma Irradiatable up to 50 kGy
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 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
Particle Release The filtrate complies with USP <788> test for particulate matter in injections
Indirect Food Additive All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
Good Manufacturing Practice These products are manufactured in a facility which adheres to Good Manufacturing Practices
Oxidizable Substances Within limits as specified in USP
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

Type
AseptiCap WS
(0.2μm upstream)
LWS1
AseptiCap WS
(0.45μm upstream)
LWSX
Size
Size Code
5" 53
10" 54
20" 55
30" 56
Pore Size
Pore Size
Code
0.1µm 36
Inlet/Outlet
Connection Code
1½” Sanitary Flange
E
3/4" Sanitary Flange**** S
3/8” Hose Barb I
Single Step ½” Hose Barb Q
1” Hose Barb* Z
Radiation Sterilizable
Code
Yes R
No* X
Inline/T-Line
Code
Inline X
T-line** T
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
1 01

*1” Hose Barb is not available in 5” capsule filters

** Gamma sterilized filters cannot be gamma irradiated again

*** T-line Capsule Filters are available with 1½” Sanitary Flange I/O Connections Only

****3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filters


     Example:

LWS1 54 36 QQ R X 1 01
Example for Non Sterile: LWS15436QQRX101                                                            Example for Gamma Sterile: LWS15436QQXX301

Datasheet Download

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