LKLX, LKS5, LKS3, LKL Single Layer, LKS 0.8 μm Upstream, LKS 0.65 μm Upstream, LKS55402EERT101, capsule filters, gamma sterile filters, 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 |
0.45μm Hydrophilic PES |
| Final Filter Pore Size |
0.2 μm |
| Prefilter Pore Size |
0.8 µm, 0.65 µm, 0.45 µm |
| Support Layers |
Polyester |
| Body and Core |
Polypropylene |
| Size |
| Size |
|
| Effective Filtration Area (Nominal) |
| 3000cm² | 6000cm² | 12000cm² | 18000cm² |
|
| Dimensions (End to End) - 1½" Sanitary Flange I/O |
|
| Dimension (End to End) - 1½" Sanitary Flange Inlet ½" Hose Barb Outlet |
|
| Dimension (End to End) - ¾" Sanitary Flange I/O |
|
| Dimensions (End to End) - ½" Single Step Hose Barb I/O |
|
| Dimension (End to End) - 1" Hose Barb I/O |
|
| Operational Radius (with Vent/ Drain) |
|
| Dimension (End to End) - 3/8" Hose Barb I/O |
| 211 mm | 332 mm | 634 mm | 885 mm | |
| Vent and Drain |
¼" Hose Barb with Silicone "O" rings
|
|
| Integrity Testing / Retention |
| Bubble Point |
> 50psi (3.52Kg/cm²)with Water |
| Max. Air Diffusion Flows (10") |
| < 30ml/min @ 37psi (2.6Kg/cm²) with Water | < 35ml/min @ 22psi (1.54Kg/cm²)with Water |
|
| Microbial Retention |
LRV >7 for Brevundimonas diminuta (ATCC 19146) per cm² |
| Operational |
| Max. Operating Temperature |
80 °C @ < 2 Kg/cm² (30 psi) |
| Max. Differential Pressure |
< 4 Kg/cm² (60 psi) @ 30 °C |
| pH Compatibility |
Compatible with pH range of 1-10 |
| Sterilization By Irradiation |
Gamma Irradiatiable up to 50 kGy. Gamma sterilized capsule 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 |
| 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 10 liter flush for 5” capsule filters and 20 liter flush for 10” capsule filters |
| Quality Management System |
ISO-9001 Certified |
| USFDA |
DMF No. 015554 |
| Type | LKL (Single Layer)
| LKLX | LKS (0.8 μm Upstream)
| LKS5 | LKS (0.65 μm Upstream)
| LKS3 | | | Size | | Size | Code | | 5" | 53 | | 10" | 54 | | 20" | 55 | | 30" | 56 | | | Pore Size | | Pore Size | Code | | 0.45µm | 02 | | | I/O Connection | | Connection | Code | | 1½" Sanitary Flange | E | | 3/4” Sanitary Flange*** | S | | 3/8” Hose Barb | I | | 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 | |
* Gamma sterilized filters cannot be gamma irradiated again
** T-line is not available in 5" Capsule filter
** T-line Capsule filter are available with 1½" Sanitary Flange I/O connection only
***3/4" Sanitary Flange end connection is available only in 5" and 10" capsule filter
