UA-44035381-1
  • 0.2μm AseptiPrime KS 5", 10" 20", 30"

0.2μm AseptiPrime KS 5", 10" 20", 30"

mdi AseptiPrime KS are sterilizing grade PES membrane cartridge filters specially designed for very high throughputs.The special optimized pre -filter membrane layer offers high loading and volume handling capacities to provide enhanced protection to the final membrane layer.

These filters meet key process requirements such as high retention efficiency, very high protein recoveries,extremely low extractables, high throughputs , wide chemical compatibility etc.

  • Absolute retention
  • 100% integrity tested
  • Low protein binding
  • Low extractables

Sterile filtration of:

  • Cell culture media
  • Cell culture media containing serum
  • Media additives
  • Buffers
  • pH adjusters
  • Final product concentrates
Construction
Membrane Hydrophilic Polyethersulfone
Final Filter Pore Size
0.2 µm 0.45 µm
Prefilter Pore Size
0.8 µm, 0.65 µm, 0.45 µm 0.65 µm, 0.8 µm
Support Layers Polyester
Body and Core Polypropylene
Integrity Testing / Retention
Bubble Point > 50psi (3.52 Kg/cm²) with Water
Microbial Retention LRV >7 for B.diminuta (ATCC 19146) per cm²
Air Diffusion Flow (10")
< 30ml/min @ 37 psi (2.6Kg/cm²) with Water < 35ml/min @ 22 psi (1.54Kg/cm²) with Water
Size
Size
5" 10" 20" 30"
Effective Filtration Area (Nominal)
3000cm² 6000cm² 12000cm² 18000cm²
Operational
Max. Operating Temperature 80°C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure 50 psi (3.5 Kg/cm²) @ 25°C
Reverse Pressure < 0.7 Kg/cm² (10 psi) @ 25 °C
Sterilization In-line steam sterilizable at 135°C for 30 minutes at a maximum differential pressure of 3 psi (0.21 kg/cm²), 25 cycles
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 The filtrate Complies with USP <788> test for particulate matter 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
AseptiPrime KS
(0.5μm Upstream)
CKH7
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

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

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

     Example :

CKH7 56 01 A0 SS 1 01
Datasheet Download
Certificate of Quality Download

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