UA-44035381-1
  • 0.45μm AseptiCap<sup>®</sup> KL/KS 25mm, 50mm

0.45μm AseptiCap® KL/KS 25mm, 50mm

mdi produces a wide range of Sterilizing grade PES membrane devices to meet filtration requirements of biopharmaceutical processing. These filter devices are validated to meet compendia and regulatory requirements and are well characterized. They meet key process requirements such as high retention efficiency, very high protein recoveries, extremely low extractables, high throughputs, wide chemical compatibility and other important characteristics.

With the advantages of pre-filtration layer built into the device for higher throughputs, linear scalability of filter area for smooth transitions from lab scale to pilot to process scale and widest range of end connections for quick and reliable connections to the existing fittings,mdi AseptiCap KL/KS filters are a universal solution for process filtration.

  • Absolute retention
  • 100% integrity tested
  • Low protein binding
  • Very low hold up volume in filters
  • High flow rates
  • Serial construction with prefilter for higher throughput with fouling streams
  • Bioburden maintained below 1000 cfu/device
  • Endotoxin level certified to be <0.25 EU/ml
  • Widest range of end connections
  • Products available for total scalability from a few ml to thousands of liters
  • Total traceability through unique serial number for each filter
  • Individual certificate of quality for each device
  • Sterilizable by EO gas or autoclaving

Bioburden Reduction/ Particulate Removal

  • Buffers
  • Centrifuge supernatants
  • Clarified cell lysates

Construction
Membrane 0.45μm Hydrophilic PES
Body and Core Polypropylene
Size
Size
25 mm50 mm
Effective Filtration Area (Nominal)
5cm²20cm²
Operational Radius (with Vent/ Drain)
15 mm28 mm
Integrity Testing / Retention
Bubble Point > 30psi (2.11Kg/cm²) with Water
Microbial Retention LRV >7 for Serratia marcescens (ATCC 14756) per cm²
Operational
Max. Operating Temperature
55°C60°C
Max. Differential Pressure
75 psi (5 Kg/cm²) @ 25 °C42 psi (3 Kg/cm²) @ 30 °CC
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 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 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 500ml flush Integrity Testing/ Retention Size Assurance Operational DST
Quality Management System ISO-9001 Certified
USFDA DMF No. 015554

0.45µm AseptiCap® KL/KS (25 mm)

Type
IKL (Single Layer)
 IKLX
IKS (0.65 μm Upstream)
 IKS3
IKS (0.8 μm Upstream)
 IKS5
Size
Dia Code
25mm 06
Pore Size
Pore Size Code
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

Example :

IKS5 06 02 MN X X 1 04

0.45µm AseptiCap® KL/KS (50 mm)

Type
IKL (with vent) (Single Layer)
 VKLX
IKS (with vent) (0.65 μm Upstream)
 VKS3
IKS (with vent) (0.8 μm Upstream)
 VKS5
VKL (with vent) (Single Layer)
 IKLX
VKS (with vent) (0.65 μm Upstream)
 IKS3
VKS (with vent) (0.8 μm Upstream)
 IKS5
Size
Dia Code
50mm 10
Pore Size
Pore Size Code
0.45µm 02
I/O Connection
Connection Code
¼" Stepped Hose Barb B*
¾" Sanitary Flange S*
Female Luer Lock M**
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
12 08

*¼" Stepped Hose Barb and ¾" Sanitary Flange are available in filters with vent only

**Female luer lock is available in filters without vent only

Example :

VKS5 10 02 BB X X 1 08

Datasheet Download
Certificate of Quality Download