AseptiVent® VF-γ 1", 2", 5", 8"
mdi AseptiVent® VF-γ gamma sterilizable PVDF membrane vent filters are validated for microbial retention with liquid bacterial challenge test as per ASTM F838-05 to provide a high degree of sterility assurance for critical applications.
| 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 (Nominal) |
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| Dimension (End to End) - Quick Connector |
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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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| Dimension (End to End) - ½" Hose Barb I/O |
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| Dimension (End to End) - ¼" SHB |
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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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| Vent and Drain | ¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only | ||||
| Integrity Testing / Retention | |||||
| Bubble Point | > 18 psi (1.26 Kg/cm²) with 50% IPA/Water | ||||
| Microbial Retention | LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² | ||||
| 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. | ||||
| Assurance | |||||
| Toxicity | Passes Bioreactivity test, In Vivo, as per USP <88> for Class VI plastics | ||||
| Bacterial Endotoxin | AAqueous 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 | ||||
| Bacterial Retention | LRV >7 for B. diminuta per cm² of filter area as per ASTM F 838-05 (liquid bacterial Challenge) | ||||
| 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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*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
****Gamma sterilized filters cannot be gamma irradiated again
Example :
| DVLX | 57 | 01 | EE | R | X | 1 | 01 |
