UA-44035381-1
  • 0.1μm AseptiPrime KS Mini 2.5", 5"

0.1μm AseptiPrime KS Mini 2.5", 5"

mdi AseptiPrime KS are sterilizing grade PES membrane mini 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 0.1 µm
Prefilter Pore Size 0.3µm or 0.5µm
Support Layers Polyester
Body and Core Polypropylene
Integrity Testing / Retention
Bubble Point > 31psi (2.18 Kg/cm²) with 50% IPA/Water Solution
Microbial Retention LR V >7 for Acholeplasma laidlawii (ATCC 23206) per cm²
Size
Size
2.5" 5"
Effective Filtration Area (Nominal)
1000cm² 2000cm²
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 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
AseptiPrime KS
(0.3μm Upstream)
CKH9
AseptiPrime KS
(0.5μm Upstream)
CKH7
Size
Code
2.5" 50
5" 53
Pore Size
Code
0.1µm 36
Adapter
Code
4463 E0
4463B H0
4440 U0
Seal-K
G0*
Seal-O
F0**
Seal-M
J0
Elastomer
Code
Silicone SS
Sterility
Code
Non Sterile 1
Pack Size
Pack Size Code
1 01

*G0 adapter code is not available with any elastomer. Please mention XX in place of elastomer code while ordering

**Adapter code F0 is available only in 5” cartridge filters

     Example:

CKH7 53 36 E0 SS 1 01
Datasheet Download

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