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0.2μm AseptiPrime<sup>®</sup> KS-γ Inline

0.2μm AseptiPrime® KS-γ Inline

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.

  • Higher 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
Size
Size
25 mm 50 mm
Effective Filtration Area
5 cm² 20 cm²
Dimension (End to End) – ¼” – 3/8″ Stepped Hose Barb I/O
— 79 mm
Dimension (End to End) – ¾” Sanitary Flange I/O
– 51 mm
Dimension (End to End) – ⅛” Hose Barb I/O
36 mm –
Dimension (End to End) – Female Luer Lock Inlet/ Male Luer Slip Outlet
23 mm –
Dimension (End to End) – ¼” Single Step Hose Barb I/O
38 mm —
Operational Radius (with Vent/ Drain)
15 mm 28 mm
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
Operational
Max. Operating Temperature
55°C 60°C
Max. Differential Pressure
75 psi (5 Kg/cm²) @ 25 °C 42 psi (3 Kg/cm²) @ 30 °C
Sterilization By Irradiation Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized.
Shelf Life 2 years after Gamma Sterilization
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
pH Compatibility Compatible with pH range of 1-10

AseptiPrime® KS- γ (25mm) PES Membrane Capsule filters

Type
AseptiPrime® KS-γ (0.5μm optimized pre-filter) IKX7
Size
Dia Code
25mm 06
Pore Size
Pore Size Code
0.2µm 01
I/O Connection
Connection Code
Female Luer lock M
Male Luer Slip N
⅛” Hose Barb H
Radiation Sterilizable
Code
Yes R
No* X
X
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
100 04

* Gamma sterilized filters cannot be gamma irradiated again

Example:

IKX7 06 01 MN R X 1 04

Example for Non Sterile: IKX70601MNRX104          Example for Gamma Sterile: IKX70601MNXX304

AseptiPrime® KS- γ (50mm) PES Membrane Capsule filters

Type
AseptiPrime® KS-γ (0.5μm optimized pre-filter) VKX7
Size
Dia Code
50mm 10
Pore Size
Pore Size Code
0.2µm 01
I/O Connection
Connection Code
¼” Stepped Hose Barb B
¾” Sanitary Flange S
Female Luer Lock M
Radiation Sterilizable
Code
Yes R
No* X
X
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
10 02

* Gamma sterilized filters cannot be gamma irradiated again

Example:

VKX7 10 01 BB R X 1 02

Example for Non Sterile: VKX71001BBRX102          Example for Gamma Sterile: VKX71001BBXX302

File Type Download
Datasheet Download
COQ Download

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