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

0.1µm AseptiCap KS 1", 2", 5", 8"

mdi AseptiCap KS PES membrane capsule filters are validated for mycoplasma removal and are used for sterile media filtration in mammalian cell culture. The filters meet key process requirements such as high retention efficiency, very high protein recoveries, extremely low extractables, high throughputs, wide chemical compatibility etc.

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 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)
250cm²500cm²1000cm²2000cm²
Dimension (End to End) - ½" Hose Barb I/O
90 mm112 mm164 mm215 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
-- 111 mm 162 mm 212 mm
Dimension (End to End) - ¾" Sanitary Flange I/O
91 mm 103 mm 155 mm 205 mm
Dimension (End to End) - 1½" Sanitary Flange I/O
91 mm110 mm161 mm211 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
--115 mm165 mm217 mm
Clean water Flow Rate @ 10 psi with ½" Hose Barb Connection
1.3 lpm2.5 lpm4.8 lpm6.5 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
pH Compatibility Compatible with pH range of 1-10
Sterilization By Gas Sterilizable by Ethylene Oxide
Sterilization By Autoclave Autoclavable at 125°C for 30 minutes, 25 cycles and it cannot be in-line steam sterilized
Shelf Life 3 years after EO 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 3 liter flush
Particle Release Passes USP test for particulates in injectables
Indirect Food Additive All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
Extractables with WFI Passes NVR test as per USP <661>
Good Manufacturing Practice These products are manufactured in a facility which adheres to Good Manufacturing Practices.
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

Type
AseptiCap KS (0.2μm Upstream) DKS1
AseptiCap KS (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
X
Bell
Code
Yes**** B
No X
Bell with cover**** C
Sterility
Code
Non Sterile 1
EO Sterile 2
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

    **** 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 X X 1 01
Example for Non Sterile: DKSX5736DDXX101                                                            Example for EO Sterile: DKSX5736DDXX201
Datasheet Download
Certificate of Quality Download

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