12/1/21, 1:01 PM AseptiCap KS 5", 10", 20", 30"

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AseptiCap KS 5", 10", 20", 30" (https://mdimembrane.com/products/product-by-type/capsule-filter/asepticap-kl-ks-5inch-10inch-20inch-30inch?filter=2%2C4%2C28%2C34%2C113%2C119)

AseptiCap KS 5", 10", 20", 30"

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

(https://mdimembrane.com/image/cache/catalog/demo/mdimembrane
Filters/AseptiCap/0.2um AseptiCap KL KS 5 10 20 30-800x500.jpg)

Special Features
Applications
Specifications
Ordering Information
Flow Rates
Documentation

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 0.45 μm

Prefilter Pore Size 0.8 µm, 0.65 µm, 0.45 µm 0.8 µm, 0.65 µm

Support Layers Polyester

Body and Core Polypropylene
Integrity Testing / Retention
Bubble Point > 50psi (3.52Kg/cm²)with Water > 30psi (2.11Kg/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 LRV >7 for Serratia marcescens (ATCC 14756) pe

Size
Size 5" 10" 20" 30"

Effective Filtration Area (Nominal) 3000cm² 6000cm² 12000cm² 18000cm²

Dimension (End to End) - 1½" Sanitary Flange Inlet ½"

212 mm 334 mm 620 mm 870 mm
Hose Barb Outlet
Dimension (End to End) - ¾" Sanitary Flange I/O 214 mm 335 mm -- --

Dimension (End to End) - 1½" Sanitary Flange I/O 205 mm 330 mm 600 mm 855 mm

https://mdimembrane.com/products/product-by-type/capsule-filter/asepticap-kl-ks-5inch-10inch-20inch-30inch?filter=2%2C4%2C28%2C34%2C113%2… 1/4
12/1/21, 1:01 PM AseptiCap KS 5", 10", 20", 30"
Construction
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 mm 78 mm 78 mm 78 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
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 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
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.
Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a sp
TOC/Conductivity at 25 °C
volume of purified water flush
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

I/O Connection
Size
Connection Code
Type Size Code Pore Size Inline/T-line Sterility
1½” Sanitary Flange E Pack Size
AseptiCap KS (0.45µm Upstream) LKSX 5" 53 Pore Size Code Code Code
3/4” Sanitary Flange*** S X Pack Size Code
AseptiCap KS (0.65μm Upstream) LKS3 10" 54 0.2µm 01 Inline X Non Sterile 1
3/8” Hose Barb I 1 01
AseptiCap KS (0.8μm Upstream) LKS5 20" 55 0.45µm 02 T-line* T EO Sterile 2
Single Step ½” Hose Barb Q
30" 56
1” Hose Barb Z

*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

https://mdimembrane.com/products/product-by-type/capsule-filter/asepticap-kl-ks-5inch-10inch-20inch-30inch?filter=2%2C4%2C28%2C34%2C113%2… 2/4
12/1/21, 1:01 PM AseptiCap KS 5", 10", 20", 30"

Datasheet Download (system/download_datasheet/Datasheet_0.2um Asepticap KL KS.pdf)

Certificate of Download (system/download_datasheet/Coq_Asepticap KS 0.2um

Quality large.pdf.f7163670e5957fc452eb31800d8fcea2)

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