UA-44035381-1
  • 0.2μm AseptiCap<sup>®</sup> KL/KS 1", 2", 5", 8"

0.2μm AseptiCap® KL/KS 1", 2", 5", 8"

mdi AseptiCap® KL/KS PES membrane capsule filters are available in a wide range of pore sizes, sizes and end connections to suit a multitude of sterilization applications in biopharmaceuticals for process development, pilot scale and production batch sizes.

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 0.2µm
Support Layers Polyester
Body and Core Polypropylene
Prefilter Pore Size (in case of AseptiCap KS) 0.8µm, 0.65µm, 0.45µm
Size
Size
1" 2" 5" 8"
Effective Filtration Area (Nominal)
250cm² 500cm² 1000cm² 2000cm²
Dimension (End to End) - ½" Hose Barb I/O
90 mm 112 mm 162 mm 214 mm
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
-- 112 mm 165 mm 216 mm
Dimensions (End to End) - ¾" Sanitary Flange I/O
85 mm 104 mm 155 mm 206 mm
Dimension (End to End) - 1½" Sanitary Flange I/O
92 mm 112 mm 164 mm 216 mm
Dimension (End to End) - ½" Single Step Hose Barb I/O
-- 115 mm 162 mm 218 mm
Operational Radius (with Vent/ Drain)
40 mm 65 mm 65 mm 65 mm
Vent and Drain
¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only
Integrity Testing / Retention
Bubble Point > 50psi (3.52Kg/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 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 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 3 liter flush
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

Type
AseptiCap® KL (Single Layer)
 DKLX
AseptiCap® KS (0.45 μm * Upstream)
 DKSX
AseptiCap® KS (0.65 μm Upstream)
 DKS3
AseptiCap® KS (0.8 μm Upstream)
 DKS5
Size
Size
 Code
1" 51
2" 52
5" 53
8" 57
Pore Size
Pore Size Code
0.2µm 01
I/O Connection
Connection Code
¼" SHB A
¼" MNPT B
¼” BSP (19 TPI) M
¼” BSP (19 TPI) with O-ring P
¼” BSP F
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

*0.45µm upstream is available with 0.2µm pore size only

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

****Male Luer Slip is available only in 1” capsule filter as outlet

***3/16" Hose Barb end connection is available in:

  • 1" and 2" capsule filters as inlet and outlet
  • 5" capsule filters as outlet only

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

  • ½” Hose Barb outlet connections in 1", 2", 5" and 8" Capsule filters
  • ¼" SHB outlet connection in 1" capsule filters only

Example :

DKSX 57 01 DD X X 1 01
Example for Non Sterile: DKSX5701DDXX101                                                            Example for EO Sterile: DKSX5701DDXX201

asepticap kl ks small flowrates

Datasheet Download
Certificate of Quality Download