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  • 0.2µm AseptiCap<sup>®</sup> KS 5", 10", 20", 30"

0.2µm AseptiCap® KS 5", 10", 20", 30"

mdi AseptiCap® KS PES membrane large capsule filters are available in a wide range of pore sizes, sizes and end connections to suit a multitude of sterilization applications in biopharmaceuticals production processes.

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.

  • Bioburden reduction from cell harvest supernatants
  • Filtration of equilibrating, washing and elution buffers for chromatography columns
  • Sterilization of biopharmaceuticals such as vaccines and therapeutic proteins
  • Sterilization of buffers
  • Sterilization of adjuvants

Construction
Membrane Hydrophilic PES
Final Filter Pore Size 0.2 μm
Prefilter Pore Size 0.8 µm, 0.65 µm, 0.45 µm
Support Layers Polyester
Body and Core Polypropylene
Size
Size
5" 10" 20" 30"
Effective Filtration Area (Nominal)
3000cm²6000cm²12000cm²18000cm²
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet
212 mm334 mm620 mm870 mm
Dimension (End to End) - ¾" Sanitary Flange I/O
214 mm 335 mm -- --
Dimension (End to End) - 1½" Sanitary Flange I/O
205 mm330 mm600 mm855 mm
Dimensions (End to End) - ½" Single Step Hose Barb I/O
218 mm 336 mm 630 mm 890 mm
Dimension (End to End) - 1" Hose Barb I/O
-- 405 mm 635 mm 895 mm
Operational Radius (with Vent/ Drain)
78 mm78 mm78 mm78 mm
Dimension (End to End) - 3/8" Hose Barb I/O
211 mm 332 mm 634 mm 885 mm
Vent and Drain ¼" Hose Barb with Silicone "O" rings
Integrity Testing / Retention
Bubble Point > 50psi (3.52Kg/cm²)with Water
Max. Air Diffusion Flows (10")
< 30ml/min @ 37psi (2.6Kg/cm²) with Water< 35ml/min @ 22psi (1.54Kg/cm²)with Water
Microbial Retention LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm²
Operational
Max. Operating Temperature 80 °C @ < 2 Kg/cm² (30 psi)
Max. Differential Pressure < 4 Kg/cm² (60 psi) @ 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 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 ISO 11737-1 : 2018
Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
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.
TOC/Conductivity at 25 °C Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 10 liter flush for 5” capsule filters and 20 liter flush for 10” capsule filters
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Type
AseptiCap® KS (0.45µm Upstream)
 LKSX
AseptiCap® KS (0.65μm Upstream)
 LKS3
AseptiCap® KS (0.8μm Upstream)
 LKS5
Size
Size Code
5" 53
10" 54
20" 55
30" 56
Pore Size
Pore Size Code
0.2µm 01
I/O Connection
Connection Code
1½” Sanitary Flange E
3/4” Sanitary Flange*** S
3/8” Hose Barb I
Single Step ½” Hose Barb Q
1” Hose Barb Z
X
Inline/T-line
Code
Inline X
T-line* T
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
1 01

*T-line is not available in 5" Capsule filter

*T-line Capsule filter are available with 1½" Sanitary Flange I/O connection only

***3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filters


Example :

LKSX 54 01 EE X X 1 01
Example for Non Sterile: LKSX5401EEXX101                                                        Example for EO Sterile: LKSX5401EEXX201

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Datasheet Download
Certificate of Quality Download