AseptiVent TF 1", 2", 5", 8"
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 | ||||
| Integrity Testing / Retention | |||||
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| Microbial Retention | Validated as per ASTM F 838-05 | ||||
| Microbial Bacterial Retention (LRV >7 for) |
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| 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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| 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 |
