AseptiSure® TK, TK Cartridge Filters, CPTK, CPTK5301F0SS101
- 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> |
| 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 :
- 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