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

AseptiCap WS 5", 10", 20", 30"

mdi AseptiCap WS are low protein binding hydrophilic PVDF membrane capsule filters offering serial filtration incorporating a large pore size upstream membrane to protect thedownstream membrane for enhanced throughput.

These capsule filters are validated to meet compendia and regulatory requirements and are wellcharacterized. They meet key process requirements such as absolute retention efficiency, extremely lowextractables, 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
Pore size
0.2 μm0.45 μm
Prefilter Pore Size 0.45μm, 0.8μm
Support Layers Polyester
Plastic parts Polypropylene
Body and Core Gamma Stable Polypropylene
Integrity Testing / Retention
Microbial Retention
LRV>7 for B. diminuta (ATCC19146) per cm2LRV>7 for S. marcescens (ATCC 14756) per cm²
Bubble Point (with 50% IPA) >31psi (2.18 Kg/cm²) with 50% IPA/ water solution
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 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
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
(0.45 μm upstream)
LWSX
AseptiCap WS
(0.8 μm upstream)
LWS5
Size
Size Code
5" 53
10" 54
20" 55
30" 56
Pore Size
Pore Size
Code
0.2µm 01
0.45µm* 02
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
X
Inline/T-Line
Code
Inline X
T-line** T
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
1 01

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

** 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

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


     Example:

LWSX 54 01
QQ X
X 1 01
Example for Non Sterile: LWSX5401QQXX101                                                            Example for EO Sterile: LWSX5401QQXX201

Datasheet Download
Certificate of Quality Download

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