AseptiCap® VK-γ Large
MDI AseptiCap® VK-γ capsule filters incorporate a specially designed combination of validated sterilizing grade hydrophobic PVDF as well as hydrophilic Polyethersulfone (PES) membrane to facilitate and provide unique performance advantages in pre-use integrity testing of aseptic filtration systems.
AseptiCap® VK-γ capsule filters help carry out critical functions such as filter wetting and integrity testing while maintaining sterility of the aseptic filtration system.
- Absolute retention
- 100% integrity tested
- Very low hold up volume in filters
- High flow rates
- Bioburden maintained below 1000 cfu/device
- Endotoxin level certified to be <0.25 EU/ml
- Widest range of end connections
- Products available for total scalability
- Total traceability through unique serial number for each filter
- Sterilizable by Gamma irradiation
- Allows unlimited water for injection (WFI) flushing of sterilizing grade product filter for easy wetting
- Allows fast drying of the filtration system necessary for processes involving oily solutions
- Acts as a sterile barrier against inadvertent ingress of environmental air
| Construction | |||
| Membrane | Hydrophobic PVDF and Hydrophilic PES | ||
| Support Layers | Polyester | ||
| Plastic parts | Gamma Stable Polypropylene | ||
| Size | |||
| Size |
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| Effective Filtration Area (Nominal) |
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| Operational Radius (with Vent/ Drain) |
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| Vent and Drain | ¼” Hose Barb with Silicone “O” ring | ||
| Integrity Testing / Retention | |||
| Bubble Point | >18 psi (1.26 Kg/cm²) with 50% IPA/water solution | ||
| Microbial Retention | LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² | ||
| Operational | |||
| Max. Operating Temperature | 80 °C @ < 30 psi (2 Kg/cm²) | ||
| Max. Differential Pressure | 60 psi (4 Kg/cm²) @ 30 °C | ||
| Shelf Life | 2 years after gamma sterilization | ||
| Assurance | |||
| 100% Integrity Tested | Each AseptiCap® VK-γ is tested for integrity to comply with validated Acceptable Integrity Test Specifications. | ||
| Toxicity | Passes Biological Reactivity tests, 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 < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP <85> | ||
| Non Fiber Releasing | Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release | ||
| Sterilization by Gamma Irradiation | Gamma Irradiatable up to 50 kGy. These filters should not be autoclaved or in-line steam sterilized. | ||
| Indirect Food Additive | Comply with USFDA 21 CFR Part 177.1520 | ||
| Bacterial Retention | LRV> 7 for B. diminuta (ATCC 19146) per cm² of filter area as per ASTM F 838 | ||
| Oxidizable Substances | Passes test as per USP <1231> | ||
| Quality Management System | ISO-9001 Certified | ||
| USFDA | DMF No. 015554 | ||
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a: Gamma irradiated filters can not be gamma sterilized again
*1″ Hose Barb is not available in 5″ capsule filters
Example:
| LVKX | 53 | 01 | EE | R | X | 1 | 01 |
Example for Non Sterile: LVKX5301QQRX101 Example for Gamma Sterile: LVKX5301QQXX301
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