DKLX single layer, DKS5, DKS3, DKS 0.8 μm Upstream, DKS 0.65 μm Upstream, DKLX5102QQRX101, DKLX5102QQXX301, capsule filters, gamma sterile, filters
- Absolute retention
- 100% integrity tested
- Low protein binding
- Very low hold up volume in filters
- High flow rates
- Serial construction with prefilter for higher throughput with fouling streams
- 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 a few ml to thousands of liters
- Total traceability through unique serial number for each filter
- Individual certificate of quality for each device
- Sterilizable by Gamma irradiation
Bioburden Reduction/ Particulate Removal
- Buffers
- Centrifuge supernatants
- Clarified cell lysates
| Construction |
| Membrane |
0.45 μm Hydrophilic PES |
| Support Layers |
Polyester |
| Body and Core |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
| 250cm² | 500cm² | 1000cm² | 2000cm² |
|
| Dimensions (End to End) - 1½" Sanitary Flange I/O |
|
| Dimension (End to End) - ½" Hose Barb I/O |
|
| Dimension (End to End) - ¾" Sanitary Flange I/O |
|
| Dimension (End to End) - ½" Single Step Hose Barb I/O |
|
| Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Single Step Hose Barb Outlet |
|
| Operational Radius (with Vent/ Drain) |
|
| Vent and Drain |
¼" Hose Barb with Silicone "O" rings for 2", 5" and 8" only
|
|
| Integrity Testing / Retention |
| Bubble Point |
> 30psi (2.11Kg/cm²) with Water |
| Microbial Retention |
LRV >7 for Serratia marcescens (ATCC 14756) per cm² |
| Operational |
| Max. Operating Temperature |
80 °C @ < 2 Kg/cm² (30 psi) |
| Max. Differential Pressure |
60 psi (4 Kg/cm²) @ 30 °C |
| pH Compatibility |
Compatible with pH range of 1-10 |
| 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 <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 |
| 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 |
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 |
Within limits as specified in USP <1231> |
| Particle Shedding |
Passes USP test for particulates in injectables |
| TOC/Conductivity at 25 °C |
Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a 3 liter flush |
| Quality Management System |
ISO-9001 Certified |
| USFDA |
DMF No. 015554 |
| Type | | DKL (Single Layer) | DKLX | | DKS (0.65 μm Upstream) | DKS3 | | DKS (0.8 μm Upstream) | DKS5 | | | Size | Size
| Code | | 1" | 51 | | 2" | 52 | | 5" | 53 | | 8" | 57 | | | Pore Size | | Pore Size | Code | | 0.45µm | 02 | | | 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 | | 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
**3/16" Hose Barb end connection is available in:
- 1" and 2" capsule filters as inlet and outlet
- 5" capsule filters as outlet only
***Male luer slip is available only in 1” capsule filter as outlet
****Gamma sterilized filters cannot be gamma irradiated again
*****Bell and bell with cover 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:
