UA-44035381-1
  • AseptiCap KL/KS-γ 1", 2", 5", 8"

AseptiCap KL/KS-γ 1", 2", 5", 8"

mdi AseptiCap KL/KS- γ 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. These are gamma sterilizable up to 50 KGy for ready to use gamma sterilized disposable assemblies.

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
0.2µm0.45µm
Support Layers Polyester
Body and Core Polypropylene
Prefilter Pore Size (in case of AseptiCap KS- γ)
0.8µm, 0.65µm, 0.45µm0.8µm, 0.65µm
Integrity Testing / Retention
Bubble Point
> 50psi (3.52Kg/cm²) with Water> 30psi (2.11Kg/cm²) with Water
Microbial Retention
LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm²LRV >7 for Serratia marcescens(ATCC 14756) per cm²
Size
Size
1"2" 5"8"
Effective Filtration Area (Nominal)
250cm²500cm²1000cm²2000cm²
Dimensions (End to End) - 1½" Sanitary Flange I/O
91 mm110 mm161 mm211 mm
Dimension (End to End) - ½" Hose Barb I/O
90 mm112 mm164 mm215 mm
Dimension (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
Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet
-- 111 mm 162 mm 212 mm
Operational Radius (with Vent/ Drain)
30 mm65 mm65 mm65 mm
Vent and Drain
¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only
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 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
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 <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554
Type
AseptiCap KL-γ
(Single Layer )
DKLX
AseptiCap KS-γ
(0.45 μm* Upstream)
DKSX
AseptiCap KS-γ
( 0.65 μm Upstream )
DKS3
AseptiCap KS-γ
(0.8 μm Upstream)
DKS5
Size
Size
Code
1" 51
2" 52
5" 53
8" 57
Pore Size
Pore Size Code
0.2µm 01
0.45µm 02
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
Yes****** B
No Bell X
Bell with cover****** C
Sterility
Code
Non Sterile 1
Gamma Sterile 3
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

***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" 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 R X 1 01

Example for Non Sterile: DKLX5101QQRX101               Example for Gamma Sterile: DKLX5101QQXX301



Datasheet Download
Certificate of Quality Download

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