UA-44035381-1
  • 0.2μm AseptiPrime KS-γ 1", 2", 5", 8"

0.2μm AseptiPrime KS-γ 1", 2", 5", 8"

AseptiPrime KS-γ capsule filters use mdi PES membrane in gamma compatible polypropylene housing. No adhesives or glue are used in the manufacturing process and all bonding is done by heat welding.The products are deeply validated for use in biopharmaceutical applications.

AseptiPrime KS-γ are manufactured in class 10,000 clean rooms and ISO 9001 certified facilities. Packaging is done in double polybags for direct irradiation by gamma or for convenience of taking AseptiPrime KS-γ in clean areas for making disposable assemblies for subsequent sterilization.

  • Very high throughput
  • Absolute retention
  • 100% integrity tested
  • Low protein binding
  • Very low hold up volume in filters
  • High flow rates
  • Bioburden maintained below 1000 cfu/device
  • Endotoxin level certified to be <0.25 EU/ml
  • Widest range of end connections
  • Products available for total scalability from a few ml to thousands of liters
  • Total traceability through unique serial number for each filter
  • Individual certificate of quality for each device
  • Sterilizable by Gamma irradiation or autoclaving (1 cycle)

Sterile Filtration of :

  • Cell culture media
  • Cell culture media containing serum
  • Media additives
  • Final product concentrates
Construction
Membrane Hydrophilic PES
Final Filter Pore Size 0.2μm
Prefilter Membrane 0.5μm PES
Support Layers Polyester
Plastic parts Gamma Stable Polypropylene
Integrity Testing / Retention
Bubble Point > 50 psi (3.52 Kg/cm² ) with Water
Max. Air Diffusion Flows (10") < 30 ml/min @ 37 psi (2.6 Kg/cm²) with water
Microbial Retention LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm²
Size
Size
1" 2" 5" 8"
Effective Filtration Area (Nominal)
250cm² 500cm² 1000cm² 2000cm²
Dimensions (End to End) - 1½" Sanitary Flange I/O
91 mm110 mm161 mm211 mm
Dimension (End to End) - ½" Hose Barb I/O
90 mm112 mm164 mm215 mm
Dimension (End to End) - ¼" SHB I/O
94 mm
122 mm172 mm223 mm
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O
91 mm103 mm155 mm205 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
-- 115 mm 165 mm 217 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
--111 mm162 mm212 mm
Operational Radius (with Vent/ Drain)
30 mm65 mm65 mm65 mm
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure 60 psi (4 Kg/cm²) @ 30 °C
pH Compatibility Compatible with pH range of 1-10
Sterilization By Irradiation

Gamma Irradiatiable up to 50 kGy

Shelf Life 2 years after Gamma Sterilization
Hold-up Volume
< 5ml < 25ml < 45ml < 60ml
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
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
TOC and Conductivity Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 3 liter flush
Indirect Food Additive Comply with USFDA 21 CFR Part 177.1520
Extractables with WFI Passes test as per USP
Oxidizable Substances Within limits as specified in USP
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Type
AseptiPrime KS-γ (0.5μm optimized pre-filter) DKX7
Size
Length
Code
1" 51
2" 52
5" 53
8" 57
Pore Size
Pore Size Code
0.2µm 01
I/O Connection
Connection Code
¼" SHB A
½” Hose Barb D
1½" Sanitary Flange E
¾" Sanitary Flange S
Quick Connector J
Single Step ½” Hose Barb* Q
Female Luer Lock U
Male Luer Slip** W
3/8" Hose Barb* I
3/16" Hose Barb*** N
Radiation Sterilizable
Code
Yes R
No**** X
X
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
1 01

*Single step ½” Hose Barb and 3/8" Hose Barb is not available in 1” Capsule Filters

**Male luer slip is available only in 1” capsule filter as outlet

***3/16" Hose Barb end connection is available in:

  • 1" and 2" capsule filters as inlet and outlet
  • 5" capsule filters as outlet only

****Gamma irradiated capsule filters cannot be gamma sterilized again


Example:

DKX7 57 01 DD R X 1 01

Example for Non Sterile: DKX75101QQRX101               Example for Gamma Sterile: DKX75101QQXX301


Datasheet Download
Certificate of Quality Download

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