UA-44035381-1
  • 0.2μm Polyethersulfone Membrane Capsule Filters Type MDKL

0.2μm Polyethersulfone Membrane Capsule Filters Type MDKL

MDKL capsule filter are specially designed for use in formulation/process development labs and compounding pharmacies.

These provide a large area filtration device for small volumes of difficult to filter solutions and are available with special end connections to allow use with syringe or peristaltic pump.

  • Absolute retention
  • 100% integrity tested
  • Low protein binding
  • Low extractables
  • Very low hold up volume in filters

Sterile Filtration of:

  • Cell culture media
  • Cell culture media containing serum
  • Media additives
  • pH adjusters
  • Final product concentrates
  • Small volume parenterals
Construction
Membrane Hydrophilic Polyethersulfone
Pore size 0.2 μm
Accuracy
Bubble point > 50psi (3.51Kg/cm²) with Water
Operating Conditions
Maximum Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Operational
Sterilization By Autoclave Autoclavable at 125°C for 30 minutes. Cannot be in-line steam sterilized
Maximum Operating Pressure 60 psi (4 Kg/cm²) @ 25 °C
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 as per USP <85>
Microbial Retention LRV >7 for B. diminuta (ATCC 19146) per cm²
Fiber Release Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
TOC and Conductivity Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a specified minimal flush
Particle Release The filtrate complies with USP <788> test for particulate matter in injections
Extractables with WFI Passes NVR test as per USP <661>
Oxidizable Substances Passes test as per USP <1231>
Type
MDKL MDKL
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
X
X
Sterility
Code
Non Sterile 1
EO Sterile 2
Pack Size
Pack Size Code
1 01


     Example:

MDKL 52 36 BA X X 1 01
Example for Non Sterile: MDKL5201BAXX101                                        Example for EO Sterile: MDKL5201BAXX201

Datasheet Download