AseptiVent® TF Inline
MDI AseptiVent® TF Disposable inline PTFE gas filters are convenient pre-fabricated devices used for sterilization of gases and as a bacterial air vent in various pharmaceutical and biopharmaceutical processes.
- 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 | ||||
| Bubble Point |
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| Microbial Retention |
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| Size | ||||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) – Female Luer Lock Inlet/ Male Luer Slip |
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| Dimension (End to End) – ¾” Sanitary Flange |
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| Dimension (End to End) – ¼” SHB |
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| Dimension (End to End) ⅛” MNPT |
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| Operational Radius (with Vent/ Drain) |
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| Operational | ||||
| Max. Operating Temperature | 60°C | |||
| Max. Differential Pressure | 3Kg/cm² (42 psi) @ 30 °C | |||
| Burst Pressure |
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| Sterilization By Gas | Sterilizable by Ethylene Oxide | |||
| Sterilization By Autoclave | Autoclavable at 125°C for 30minutes, 30 cycles and it cannot be in-line steam sterilized | |||
| Shelf Life | 3 years after EO 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 | |||
| 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 | |||
| Microbial Retention | Validated as per ASTM F 838 | |||
| 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 injections | |||
| Quality Management System | ISO-9001 Certified | |||
| USFDA | DMF No. 015554 | |||
AseptiVent®- TF (25mm)
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*Female Luer Lock is available as Inlet only
**Male Luer Slip is available as Outlet only
Example :
| ITFX | 06 | 01 | MN | XX | 1 | 04 |
Example for Non Sterile: ITFX0801BBXX104
Example for EO Sterile: ITFX0601MNXX204
AseptiVent®- TF (37mm, 50mm)
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*Note: AseptiVent® TF- 37 mm is available with BB connection only
**37mm filter is available in pack of 20 only
Example :
| ITFX | 08 | 01 | BB | XX | 1 | 09 |
Example for Non Sterile: ITFX0801BBXX109
Example for EO Sterile: ITFX0801BBXX209
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