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- High throughput
- 100% integrity tested
- Low protein binding
- High flow rates
- Biologically Inert
- Easy Installation
- 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 from lab to process development to manufacturing
- Total traceability through unique serial number for each filter
- Individual certificate of quality for each device
- Sterilizable by Gamma irradiation
Virus culture harvest for cell and gene therapy processes
Viral vectors are cultured in mammalian cells such as HEK 293 and clarification of the virus culture is a challenge for the process owner. Whole cells and cell debris which includes colloidal particles, lipids and cell fragments are difficult to remove and pose a risk to downstream processes such as Tangential flow Filtration ( TFF), Ion exchange Chromatography and Size Exclusion Chromatography.
HarvestPro™ capsule filters provide an efficient filtration system for removal of whole cells and cell debris.
| Construction |
| Membrane |
Hydrophilic PES |
| Prefilter Membrane |
Microglassfiber |
| Support Layers |
Polyester |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
|
| Operational Radius (with Vent/ Drain) |
|
| Operational |
| Max. Operating Temperature |
60 °C |
| Max. Differential Pressure |
42 psi (3 Kg/cm²) @ 30 °C |
| Sterilization By Irradiation |
Gamma Irradiatiable up to 50 kGy. These filters must 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 <88> for Class VI plastics |
| 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 |
| Indirect Food Additive |
All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177.1520 |
| Extractables with WFI |
Passes NVR test as per USP <661> |
| Good Manufacturing Practice |
These products are manufactured in a facility which adheres to Good Manufacturing Practices |
| Oxidizable Substances |
Passes test as per USP <1231> |
| Quality Management System |
ISO-9001 Certified |
| USFDA |
DMF No. 015554 |
HarvestPro™-γ 25mm
| | | | Pore Size | Pore Size
| Code | | 0.5µm | 04 | | | I/O Connection | | Connection | Code | | Female Luer Lock | M | | Male LuerSlip | N | | ⅛" Hose Barb | H
| | ¼" Hose Barb | B | | | Radiation Sterilizable | | Code | | Yes | R | | No* | X | | | | Sterility | | Code | | Non Sterile | 1 | | Gamma Sterile | 3 | | | Pack Size | | Pack Size | Code | | 100 | 04 | |
Example :
* Gamma sterilized filters cannot be gamma irradiated again Example for Non Sterile: IKGX0604MNRX104 Example for gamma Sterile: IKGX0604MNXX304
HarvestPro™-γ 50mm
| Type | HarvestPro™-γ
| VKGX (with vent) | HarvestPro™-γ
| IKGX (without vent) | | | | Pore Size | Pore Size
| Code | | 0.5µm | 04 | | | I/O Connection | | Connection | Code | | ¼” SHB | B** | | ¾" Sanitary Flange | S** | | Female Luer Lock | M*** | | | Radiation Sterilizable | | Code | | Yes | R | | No* | X | | | | Sterility | | Code | | Non Sterile | 1 | | Gamma Sterile | 3 | | | Pack Size | | Pack Size | Code | | 10 | 02 | |
Example :
*Gamma sterilized filters cannot be gamma irradiated again
**¼" Stepped Hose Barb and ¾" Sanitary Flange are available in filters with vent only
***Female luer lock is available in filters without vent only
Example for Non Sterile: VKGX1004BBRX102 Example for gamma Sterile: VKGX1004BBXX302
