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
- 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
| 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> |
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Example :
| CPTK | 53 | 01 | F0 | SS | 1 | 01 |
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