capsule filters, filters, special filters, harvestpro, harvestpro gamma
- 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 |
| Plastic parts |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
| 2500 cm² |
5000 cm² |
10000 cm² |
15000 cm² |
|
| Operational Radius (with Vent/ Drain) |
|
| Vent and Drain |
¼" Hose Barb with Silicone "O" ring |
| Operational |
| Max. Operating Temperature |
80 °C @ < 30 psi (2 Kg/cm²) |
| Max. Differential Pressure |
60 psi (4 Kg/cm²) @ 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 < 0.25 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 |
Comply with USFDA 21 CFR Part 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 |
| Type | HarvestPro™ GK-γ | LKGX | | | Size | | Size | Code | | 5" | 53 | | 10" | 54 | | 20" | 55 | | 30" | 56 | | | Pore Size | Pore Size
| Code | | 0.5µm | 04 | | | I/O Connection | | Connection | Code | | 1½" Sanitary Flange | E | | 3/8” Hose Barb | I | | 3/4” Sanitary Flange*** | S | | Single Step ½" Hose Barb | Q | | 1” Hose Barb**** | Z | | | Radiation Sterilizable | | Code | | Yes | R | | No** | X | | | Inline/T-line | | Code | | Inline | X | | T-line* | T | | | Sterility | | Code | | Non Sterile | 1 | | Gamma Sterile | 3 | | | Pack Size | | Pack Size | Code | | 1 | 01 | |
* T-line is not available in 5” Capsule Filter* T-line Capsule Filter are available with 1½” Sanitary Flange I/O Connection only** Gamma sterilized filters cannot be gamma irradiated again***3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filters****1" Hose Barb is not available in 5" capsule filters
Example :
Example for Non Sterile: LKGX5404EERX101 Example for Gamma Sterile: LKGX5404EEXX301
