AseptiVent® TF Large
MDI AseptiVent® TF PTFE large capsule filters offer absolute retention and wide chemical compatibility for sterile filtration of air/gases as well as aggressive solvents in large volume.
- Absolute Retention
- Hydrophobic
- High heat stability
- Wide chemical compatibility
- Heat sealed to ensure ‘no leaching’
- 100% Integrity tested
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Widest range of end connections
- Total traceability through unique serial number for each filter
- Individual certificate of quality for each device
- Sterilizable by EO gas or autoclaving
- Fermentor exhaust
- Sterile air sparging in fermentors and bioreactors
- Sterile venting of cell factories, bioreactors and fermentors
- Sterilization of environmental air in isolators
- Venting of sterile collection vessels
- Cleaning sterile surfaces
- WFI tank venting
- Nitrogen blanketing
- Dry powder injectable filling
- Sterile air for dryers and micronizers
| Construction | |||||
| Membrane | Hydrophobic PTFE | ||||
| Pore size |
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| Support Layers | Polypropylene | ||||
| Body and Core | Polypropylene | ||||
| Integrity Testing / Retention | |||||
| Air Diffusion Flow per 10″ Capsule Filter (70% IPA/Water Wetted) |
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| Microbial Retention |
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| Size | |||||
| Size |
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| Effective Filtration Area |
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| Dimension (End to End) – 1½” Sanitary Flange Inlet ½” Hose Barb Outlet |
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| Dimension (End to End) – ¾” Sanitary Flange I/O |
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| Dimension (End to End) – 1½” Sanitary Flange I/O |
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| Dimension (End to End) – ½” Single Step Hose Barb |
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| Dimension (End to End) – 1″ Hose Barb I/O |
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| Operational Radius (with Vent/ Drain) |
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| Dimension (End to End) – 3/8″ Hose Barb I/O |
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| Operational | |||||
| Max. Operating Temperature | 80 °C @ <30psi (2Kg/cm²) | ||||
| Max. Differential Pressure | 60psi (4Kg/cm²) @ 30 °C | ||||
| Sterilization By Gas | Sterilizable by Ethylene Oxide | ||||
| Sterilization By Autoclave | Autoclavable at 125°C for 30 minutes, 30 cycles and it cannot be in-line steam sterilized | ||||
| Shelf Life | 3 years after Ethylene Oxide 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 | ||||
| Microbial Bacterial Retention | Validated as per ASTM F 838 | ||||
| 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 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 | ||||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices | ||||
| Oxidizable Substances | Within limits as specified in USP <1231> | ||||
| Particle Shedding | Passes USP test for particulates in injectables | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*1” HB and T-line are not available in 5″ Capsule filter
*T-line Capsule filter are available with 1½” Sanitary Flange I/O connection only
**3/4″ Sanitary Flange end connection is available only in 5″ and 10″ capsule filters
***3/8″ Hose Barb is available only with inline capsule filters
Example :
| LTLX | 54 | 01 | EE | XX | X | 1 | 01 |
Example for Non Sterile: LTLX5401EEXXX101 Example for EO Sterile: LTLX5401EEXXX201
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