AseptiVent® VF-γ Large
MDI AseptiVent® VF-γ, gamma sterilizable PVDF membrane vent filters are validated for microbial retention with liquid bacterial challenge test as per ASTM F838 to provide a high degree of sterility assurance for critical applications such as small bioreactors, sterile tank venting, bottle venting etc.
| 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: | AseptiVent® is produced using a high hydrophobicity PVDF membrane. This ensures good flow rates even with high moisture content in the inlet air.
AseptiVent® capsule filters are designed to offer high air/gas flow rates at low differential pressures. |
- Sterile air sparging
- Sterile venting
- Fermentor exhaust
| Construction | |||||
| Membrane | Hydrophobic PVDF | ||||
| Pore size | 0.2 µm | ||||
| Support Layers | Polyester | ||||
| Body and Core | Gamma Stable Polypropylene | ||||
| Size | |||||
| Size |
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| Effective Filtration Area |
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| Dimensions (End to End) – 1½” Sanitary Flange I/O |
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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) – ½” Single Step Hose Barb I/O |
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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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| Vent and Drain | ¼” Hose Barb with Silicone “O” ring | ||||
| Integrity Testing / Retention | |||||
| Bubble Point (with 50% IPA) | > 1.26 Kg/cm² (18 psi) | ||||
| Bacterial Retention | LRV> 7 for B. diminuta per cm² of filter area as per ASTM F 838 (liquid bacterial Challenge) | ||||
| Operational | |||||
| Max. Operating Temperature | 80°C @ < 2Kg/cm² (30 psi) | ||||
| Max. Differential Pressure | < 4 Kg/cm² (60 psi) @ 30° C | ||||
| Sterilization By Irradiation | Gamma Irradiatiable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized. | ||||
| Shelf Life | 2 years after gamma sterilization | ||||
| Assurance | |||||
| Toxicity | Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics | ||||
| 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 | Comply with USFDA 21 CFR Part 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 | ||||
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* Gamma sterilized filters cannot be gamma irradiated again
** T-line is not available in 5” Capsule filter
** T-line Capsule Filter are available with 1½” Sanitary Flange I/O Connections Only
*** 3/4″ Sanitary Flange end connection is available only in 5″ and 10″ capsule filters
Example:
| LVLX | 54 | 01 | EE | R | X | 1 | 01 |
Example for Non Sterile: LVLX5401QQRX101 Example for Gamma Sterile: LVLX5401QQXX301
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