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) |
| 150cm² | 500cm² | 1000cm² | 1500cm² |
|
| Operational Radius (with Vent/ Drain) |
|
| Vent and Drain |
¼” Hose Barb with Silicone “O” rings |
| 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> |
| Bioburden |
Device bioburden is tested as per ISO 117 37-1 and assured to be <1000 cfu/device. |
| 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 |
| | | Size | | Size | Code | | 1" | 51 | | 2" | 52 | | 5" | 53 | | 8" | 57 | | | Pore Size | Pore Size
| Code | | 0.5µm | 04 | | | I/O Connection | | Connection | Code | | ¼” SHB | A | | ¼" MNPT | B | | ¼” BSP (19 TPI) | M | | ¼” BSP (19 TPI) with O-ring | P | | ¼” BSP | F | | ½” MNPT* | C | | ½” Hose Barb | D | | 1½" Sanitary Flange | E | | ¾" Sanitary Flange | S | | Quick Connector | J | | Single Step ½" Hose Barb* | Q | | Female Luer Lock | U | | Male Luer Slip** | W | | 3/8" Hose Barb* | I | | 3/16" Hose Barb*** | N | | | Radiation Sterilizable | | Code | | Yes | R | | No**** | X | | | Bell | | Code | | Yes***** | B | | No Bell | X | | Bell with cover | C | | | Sterility | | Code | | Non Sterile | 1 | | Gamma Sterile | 3 | | | Pack Size | | Pack Size | Code | | 1 | 01 | |
*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
***** Bell is available with
- ½” Hose Barb outlet connections in 1”, 2”, 5” and 8” capsule filters
- ¼” SHB outlet connection in 1” capsule filters only
Example :
Example for Non Sterile: DKGX5104EERX101 Example for Gamma Sterile: DKGX5104EEXX301
