AseptiVent® VF-γ 25mm, 37mm, 50mm
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 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 | 0.2µm | |||
| Support Layers | Polyester | |||
| Body and Core | Gamma Stable Polypropylene | |||
| Size | ||||
| Size |
|
|||
| Effective Filtration Area (Nominal) |
|
|||
| Dimension (End to End) - ¼" SHB I/O |
|
|||
| Dimension (End to End) - ¾" Sanitary Flange Inlet I/O |
|
|||
| Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip Outlet |
|
|||
| Operational Radius (with Vent/ Drain) |
|
|||
| Integrity Testing / Retention | ||||
| Bubble Point | > 18psi (1.26Kg/cm²) with 50% IPA/ Water Solution | |||
| Microbial Retention | LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² | |||
| Operational | ||||
| Max. Operating Temperature | 80° C @ < 0.5 Kg/cm² (7psi) | |||
| Max. Differential Pressure | 1.5 Kg/cm² (22 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 | 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 | |||
| Bacterial Retention | LRV >7 for B. diminuta per cm² of filter area as per ASTM 838-05 against 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 | |||
AseptiVent®- VF- γ 25mm
|
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||
Example :
| IVFX | 06 | 01 | MN | R | X | 1 | 04 |
Example for Non Sterile: IVFX0601MNRX104 Example for Gamma Sterile: IVFX0601MNXX304
AseptiVent®- VF- γ (37mm, 50mm)
|
|
|
|
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||
* Gamma sterilized filters cannot be gamma irradiated again
***37mm is available with ¼” SHB I/O connection and in pack size 20 only
Example :
| IVFX | 08 | 01 | BB | R | X | 1 | 08 |
Example for Non Sterile: IVFX0801BBRX109 Example for Gamma Sterile: IVFX0801BBXX309
