UA-44035381-1
  • AseptiSure<sup>®</sup> TK

AseptiSure® TK

mdi AseptiSure TK cartridge filters incorporate a specially designed combination of validated sterilizing grade hydrophobic PTFE as well as hydrophilic Polyethersulfone (PES) membrane to facilitate and provide unique performance advantages in post steam-in-place (SIP), pre-use integrity testing of aseptic filtration systems.

AseptiSure TK cartridge filters help carry out critical functions such as steam penetration, condensate removal, filter drying, filter wetting and integrity testing while maintaining sterility of the aseptic filtration system (SIP or autoclaved).

  • Absolute retention
  • 100% integrity tested
  • High heat stability
  • Total Traceability: Unique marking on each filter
  • Individual COQ for each filter
Construction
Membrane Hydrophobic PTFE and Hydrophilic PES
Pore size 0.2 μm
Integrity Testing / Retention
Bubble Point > 16psi (1.12 Kg/cm²) with 70% IPA
Operating Conditions
Maximum Operating Temperature 80 °C @ < 30 psi (2 Kg/cm²)
Maximum Differential Pressure 50 psi (3.51 Kg/cm²) @ 30 °C
Operational
Typical Air Flow Rates (After passage of steam condensate) 6 Nm³/h at ▲P=1.5psi
Typical Water Flow Rates 18 lpm @ 1.4 kg/cm² at 27°C
Sterilization Autoclavable/ In-line steam sterilizable at 135°C for 30 minutes, 4 cycles.
Assurance
Toxicity Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics.
Cytotoxicity Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP<87>
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85>
Bioburden Bioburden level is < 1000 cfu/filter device as per ANSI/AAMI/ISO 11737-1: 1995
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
Oxidizable Substances Passes test as per USP <1231>
Type
AseptiSure® TK
 CPTK
Size
Size Code
5" 53
10" 54
Pore Size
Pore Size
 Code
0.2µm 01
Adapter
Code
7P A0
Seal-M J0
Seal-O F0
Elastomer
Code
Silicone SS
Sterility
Code
Non Sterile 1
Pack Size
Pack Size Code
1 01


     Example :

CPTK 53 01 F0 SS 1 01
Datasheet Download

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  • Allows unlimited water for injection (WFI) flushing of sterilizing grade product filter for easy wetting for post SIP, pre-use integrity testing
  • Allows fast drying of the filtration system necessary for processes involving oily solutions/li>
  • Acts as a sterile barrier against inadvertent ingress of environmental air