UA-44035381-1
  • 0.1µm AseptiCap KS-γ 1", 2", 5", 8"

0.1µm AseptiCap KS-γ 1", 2", 5", 8"

mdi AseptiCap KS-γ PES membrane capsule filters are validated for mycoplasma removal and are used for sterile media filtration in mammalian cell culture.

These are gamma sterilizable and are available in a wide range of sizes and end connections.

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
Upstream Membrane 0.2 µm or 0.45 µm Hydrophilic PES
Support Layers Polyester
Plastic parts Gamma Stable Polypropylene
Integrity Testing / Retention
Bubble Point > 31psi with 50% IPA/Water solution
Bacterial Retention LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area
Size
Size
1" 2" 5" 8"
Effective Filtration Area (Nominal)
250cm² 500cm² 1000cm² 2000cm²
Dimensions (End to End) - 1½" Sanitary Flange I/O
91 mm 110 mm 161 mm 211 mm
Dimension (End to End) - ½" Hose Barb I/O
90 mm 112 mm 164 mm 215 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
-- 111 mm 162 mm 212 mm
Dimensions (End to End) - ¾" Sanitary Flange I/O
91 mm103 mm155 mm205 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
-- 115 mm 165 mm 217 mm
Clean water Flow Rate @ 10 psi with ½" Hose Barb Connection
1.3 lpm 2.5 lpm 4.8 lpm 6.5 lpm
Operational Radius (with Vent/ Drain)
30 mm 65 mm 65 mm 65 mm
Vent and Drain
¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only
Operational
Max. Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Max. Differential Pressure 60 psi (4 Kg/cm²) @ 30 °C
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 Comply with USFDA 21 CFR Part 177.1520
Extractables with WFI Passes NVR test as per USP <661>
Oxidizable Substances Within limits as specified in USP <1231>
Particle Shedding Passes USP test for particulates in injectables
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
pH Compatibility Compatible with pH range of 1 - 10
Type
AseptiCap KS-γ (0.2 µm Upstream) DKS1
AseptiCap KS-γ (0.45µm Upstream) DKSX
Size
Size Code
1" 51
2" 52
5" 53
8" 57
Pore Size
Pore Size Code
0.1µm 36
I/O Connection
Connection Code
¼" SHB A
¼" MNPT B
½” MNPT* C
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
Bell
Code
Yes***** B
No Bell X
Bell with cover***** C
Sterility
Code
Non Sterile 1
Gamma Sterile 3
Pack Size
Pack Size Code
1 01

*1” Capsule Filters are not available with ½” Single step Hose Barb, ½” MNPT and 3/8" Hose Barb

**Female luer lock is available in 1” and 2” capsule filters only

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

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

***** Bell and bell with cover is available with:

  • ½" HB outlet connections in 1", 2", 5" and 8" capsule filters
  • ¼" SHB outlet connection in 1" capsule filters only

Example:

DKSX 57 36 DD R X 1 01


Example for Non Sterile: DKSX5136EERX101          Example for gamma Sterile: DKSX5136EEXX301

Datasheet Download
Certificate of Quality Download

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