AseptiVent® TF Small
MDI AseptiVent® TF capsule filters employ hydrophobic PTFE membrane offering absolute retention and very wide chemical compatibility making these useful for sterile filtration of air/gases as well as aggressive solvents.
| Consistent and Reliable Quality: | AseptiVent® capsule filters are produced with ISO 9001 certified quality management systems. |
| Regulatory Compliance: | Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554 |
| Air Flow rates/ Hydrophobicity: | Translates to lower filtration costs, less number of filter changes and overall economy of operations. |
- Fermentor exhaust
- Sterile air for cell factories
- Venting of sterile collection vessels
- Cleaning sterile surfaces
| Construction | |||||
| Membrane | Hydrophobic PTFE | ||||
| Final Filter Pore Size |
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| Support Layers | Polypropylene | ||||
| Body and Core | Polypropylene | ||||
| Size | |||||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) – ½” Hose Barb I/O |
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| Dimension (End to End) – Quick Connector |
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| Dimension (End to End) – ¼” SHB I/O |
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| Dimension (End to End) – ¾” Sanitary Flange Inlet I/O |
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| Dimension (End to End) – 1½” Sanitary Flange I/O |
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| Dimensions (End to End) – ½” Single Step Hose Barb I/O |
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| Dimensions (End to End) Inline Capsule Filters – 1½” Sanitary Flange Inlet ½” Single Step Hose Barb Outlet |
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| Operational Radius (with Vent/ Drain) |
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| Integrity Testing / Retention | |||||
| Bubble Point |
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| Microbial Retention | Validated as per ASTM F 838 | ||||
| Microbial Bacterial Retention (LRV >7 for) |
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| Operational | |||||
| Max. Operating Temperature | 80 °C @ < 2 Kg/cm² (30 psi) | ||||
| Max. Differential Pressure | < 4 Kg/cm² (60 psi) @ 30 °C | ||||
| Sterilization By Gas | Sterilizable by Ethylene Oxide | ||||
| Sterilization By Autoclave | Autoclavable at 125 °C for 30 minutes. 50 Cycles. Can not 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 | ||||
| Bacterial Endotoxin | Aqueous extracts exhibit < 0.5 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test | ||||
| 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” Capsule Filters are not available with ½” Single step Hose Barb, ½”MNPT and 3/8″ Hose Barb
**Male luer slip is available only in 1” capsule filter as outlet
***3/16″ Hose Barb end connection is available in:
- 1″ and 2″ capsule filters as inlet and outlet
- 5″ capsule filters as outlet only
Example :
| DTLX | 53 | 01 | DD | XX | 1 | 01 |
Example for Non Sterile: DTLX5301DDXX101 Example for EO Sterile: DTLX5301DDXX201
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