UA-44035381-1
  • AseptiCap KL/KS 25mm, 50mm

AseptiCap KL/KS 25mm, 50mm

mdi AseptiCap KL/KS are disposable PES membrane capsule filters offering a convenient lab scale solutions for process development with identical materials of construction for easy scale up to pilot scale and finally production scale filters.

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 o f 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
Prefilter Pore Size
0.8 µm, 0.65µm, 0.45µm0.8 µm, 0.65µm
Body and Core Polypropylene
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
25 mm50 mm
Effective Filtration Area (Nominal)
5cm²20cm²
Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip
23 mm--
Dimension (End to End) - ¾" Sanitary Flange Inlet I/O
--51 mm
Dimension (End to End) - ¼" SHB
--79 mm
Operational Radius (with Vent/ Drain)
15 mm28 mm
Operational
Max. Operating Temperature
55°C60°C
Max. Differential Pressure
5 Kg/cm² (75 Psi) @ 25° C3 Kg/cm² (42 Psi) @ 30° C
Burst Pressure
>14 Kg/cm²>8 Kg/cm²
Hold-up Volume(with air purge)
< 50µL< 300µL
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
Indirect Food Additive All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520
Extractables with WFI Passes test as per USP
Good Manufacturing Practice These products are manufactured in a facility which adheres to Good Manufacturing Practices.
Oxidizable Substances Within limits as specified in USP
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 specified minimal flush
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

AseptiCap KL/KS (25 mm)

Type
AseptiCap KL (Single Layer) IKLX
AseptiCap KS (0.45 μm Upstream)* IKSX
AseptiCap KS (0.65 μm Upstream) IKS3
AseptiCap KS (0.8 μm Upstream) IKS5
Size
Dia Code
25mm 06
Pore Size
Pore Size Code
0.2µm 01
0.45µm 02
I/O Connection
Connection Code
Female Luer Lock M
Male Luer Slip N
⅛" Hose Barb H
¼" Hose Barb B
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
100 04

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

Example :

IKSX 06 01 MN X X 1 04
Example for Non Sterile: IKSX0601MNXX104                                                   Example for EO Sterile: IKSX0601MNXX204

AseptiCap KL/KS (50 mm)

Type
AseptiCap KL (Single Layer) VKLX
AseptiCap KS (0.45 μm Upstream)* VKSX
AseptiCap KS (0.65 μm Upstream) VKS3
AseptiCap KS (0.8 μm Upstream) VKS5
Size
Dia Code
50mm 10
Pore Size
Pore Size Code
0.2µm 01
0.45µm 02
I/O Connection
Connection Code
¼" Stepped Hose Barb B
¾" Sanitary Flange** S
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
10 02

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

**¾" Sanitary Flange is available as Outlet only


Example :

VKSX 10 01 SS X X 1 02
Example for Non Sterile: VKSX1001SSXX102                                                   Example for EO Sterile: VKSX1001SSXX202

Datasheet Download
Certificate of Quality Download

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