UA-44035381-1
  • 0.1µm AseptiCap KS-γ 25mm, 50mm

0.1µm AseptiCap KS-γ 25mm, 50mm

mdi AseptiCap KS-γ are specially designed filters for process development and formulation development labs with identical materials of construction for easy scale up to larger capsule filters and cartridge filters.

50mm is a special vented device for use with peristaltic pump to ensure easy removal of entrapped air in the upstream.

These are validated for mycoplasma removal and are gamma sterilizable with up to 50 kGy for ready to use disposable assemblies.

Consistent and Reliable Quality:
AseptiCap capsule filters are produced with ISO 9001 certified quality management systems.
Regulatory Compliance:
Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554
Low Protein Binding:
Results in increased overall product yield
High Throughputs:
Translates to lower filtration costs, less number of filter changes and overall economy of operations.
Low Extractables:
Mean less addition to impurity profile of the biological product from the filters.

Sterile Filtration of:

  •  Cell culture media 
  •  Cell culture media containing serum 
  •  Media additives
  •  Final product concentrates

Construction
Membrane 0.1 µm Hydrophilic PES
Prefilter Membrane 0.2 µm or 0.45 µm Hydrophilic PES
Plastic parts Gamma Stable Polypropylene
Integrity Testing / Retention
Bubble Point > 31 psi (2.18 Kg/cm² ) with 50% IPA
Bacterial Retention LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area
Size
Size
25 mm 50 mm
Effective Filtration Area (Nominal)
5 cm²20 cm²
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip
23 mm --
Dimension (End to End) - ¼" SHB
-- 79 mm
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O
-- 51 mm
Operational Radius (with Vent/ Drain)
15 mm 28 mm
Operational
Max. Operating Temperature
55 °C 60 °C
Max. Differential Pressure
75 Psi (5 Kg/cm²)@ 25 °C42 Psi (3 Kg/cm²) @ 30 °C
pH Compatibility Compatible with pH range of 1-14
Sterilization By Autoclave Autoclavable at 125 °C for 30 minutes, 1 Cycle after gamma irradiation and it cannot be in-line steam sterilized
Sterilization By Irradiation Gamma Irradiatiable up to 50 kGy
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
Bioburden Bioburden level is < 1000 cfu/filter device as per ANSI/AAMI/ISO 11737-1 : 1995
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 specified minimal flush
Particle Release Passes USP test for particulates in injections
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
Oxidizable Substances Within limits as specified in USP
Particle Shedding Passes USP test for particulates in injectables.
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

AseptiCap KS- γ (25mm)

Type
AseptiCap KS-γ (0.2μm Upstream) IKS1
AseptiCap KS-γ (0.45μm Upstream) IKSX
Size
Dia Code
25mm 06
Pore Size
Pore Size Code
0.1µm 36
I/O Connection
Connection Code
Female Luer lock M
Male Luer Slip N
⅛" Hose Barb
H
¼" Hose Barb B
Radiation Sterilizable
Code
Yes R
No* X
X
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
100 04

* Gamma irradiated filters cannot be gamma sterlized again

Example:

IKSX 06 36 MN R X 1 04
Example for Non Sterile: IKSX0636MNRX104          Example for Gamma Sterile: IKSX0636MNXX304

AseptiCap KS- γ (50mm)

Type
AseptiCap KS-γ (0.2 μm Upstream) VKS1
AseptiCap KS-γ (0.45 μm Upstream) VKSX
Size
Dia Code
50mm 10
Pore Size
Pore Size Code
0.1µm 36
I/O Connection
Connection Code
¼" Stepped Hose Barb B
¾" Sanitary Flange** S
Radiation Sterilizable
Code
Yes R
No* X
X
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
10 02

* Gamma irradiated filters can not be gamma sterlized again

** ¾" Sanitary Flange is available as outlet only

Example:

VKSX 10 36 SS R X 1 02
Example for Non Sterile: VKSX1036BBRX102          Example for Gamma Sterile: VKSX1036BBXX302
Datasheet Download

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