UA-44035381-1
  • 0.1μm AseptiPrime KS-γ 5", 10", 20", 30"

0.1μm AseptiPrime KS-γ 5", 10", 20", 30"

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 0.1 μm
Prefilter Membrane 0.3μm or 0.5μm PES
Support Layers Polyester
Plastic parts Gamma Stable Polypropylene
Integrity Testing / Retention
Bubble Point > 30 psi ( 2.11Kg/cm² ) with 50% IPA/Water Solution
Max. Air Diffusion Flows (10") < 29 ml/min @ 50 psi (3.52 Kg/cm²) with water
Microbial Retention LRV >7 for Acholeplasma laidlawii (ATCC 23206) per cm²
Size
Size
5" 10" 20" 30"
Effective Filtration Area (Nominal)
3000cm² 6000cm² 12000cm² 18000cm²
Dimension (End to End) - ¾" Sanitary Flange I/O
212 mm 345 mm -- --
Dimension (End to End) - 1½" Sanitary Flange I/O
207 mm 326 mm 605 mm 865 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
217 mm 332 mm 628 mm 888 mm
Dimensions (End to End) Inline Capsule Filters - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
203 mm 332 mm 618 mm 878 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
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 (0.3μm optimized pre-filter) LKX9
AseptiPrime KS-γ (0.5μm optimized pre-filter) LKX7
Size
Length
Code
5"* 53
10" 54
20" 55
30" 56
Pore Size
Pore Size Code
0.1µm 36
I/O Connection
Connection Code
Single Step ½” Hose Barb Q
1½" Sanitary Flange E
3/4” Hose Barb***** S
3/8” Hose Barb I
1” Hose Barb** Z
Radiation Sterilizable
Code
Yes R
No*** X
Inline/T-Line
Code
Inline X
T-Line**** T
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
1 01

*Size 5” is available in Inline Capsule filters only

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

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

****T-line Capsule Filter 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


Example:

LKX7 54 36 EE R T 1 01

Example for Non Sterile: LKX75336QQRX101               Example for Gamma Sterile: LKX75336QQXX301


Datasheet Download
Certificate of Quality Download

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