UA-44035381-1
  • 0.2µm AseptiSure WS 5", 10", 20", 30"

0.2µm AseptiSure WS 5", 10", 20", 30"

mdi AseptiSure WS are low protein binding hydrophilic PVDF membrane cartridge filters offering serial filtration incorporating a large pore size upstream membrane to protect the downstream membrane for enhanced throughput.

These cartridge 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
  • Antibodies
  • Protein Solutions
  • Buffers
  • Vaccine concentrates
  • Small Volume Parenterals
Construction
Membrane Hydrophilic PVDF
Final Filter Pore Size 0.2µm
Prefilter Pore Size 0.45 µm
Support Layers Polyester
Plastic parts Polypropylene
Body and Core Polypropylene
Integrity Testing / Retention
Bubble Point > 50psi (3.51Kg/cm²) with Water
Microbial Retention LRV >7 for B. diminuta (ATCC 19146) per cm²
Air Diffusion Flow (10") < 29ml/min @ 50 psi (3.51 Kg/cm²) with Water
Size
Size
5" 10" 20" 30"
Effective Filtration Area (Nominal)
3000cm² 6000cm² 12000cm² 18000cm²
Operational
Max. Operating Temperature 80 °C @ < 2 Kg/cm² (30 psi)
Max. Differential Pressure 3.5 Kg/cm² (50 psi) @ 25 °C
Reverse Pressure < 0.7 Kg/cm² (10 psi) @ 25 °C
Typical Water Flow Rates (10" Cartridge filters) 22 lpm @ 0.70 Kg/cm² @ 27 °C
Sterilization
Autoclavable/ Inline steam sterilizable at 135°C for 3 cycles of 30 minutes each
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
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
Good Manufacturing Practice These products are manufactured in a facility which adheres to Good Manufacturing Practices.
Oxidizable Substances Within limits as specified in USP
Particle Shedding Passes USP test for particulates in injectables.
TOC/Conductivity at 25 °C Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Type
AseptiSure WS (0.45 μm Upstream) CWHX
Size
Size Code
5"** 53
10" 54
20" 55
30" 56
Pore Size
Pore Size
Code
0.2µm 01
Adapter
Code
7P A0
7P without fin A1
28 with fin C0
'O' D0
Elastomer
Code
Silicone SS
Viton SV
EPDM SE
FEP Encapsulated Viton FV*
Sterility
Code
Non Sterile 1
Pack Size
Pack Size Code
1 01

     *FV is available in Adapter code A0(7P) and A1(7P without fin) only

     **Size 5" is available in Adapter Code A0 (7P) and A1 (7P without fin) only

     Example :

CWHX 56 01
A0 SS 1 01
Datasheet Download
Certificate of Quality Download

Write a review

Note: HTML is not translated!
    Bad           Good