0.2µm AseptiCap® KL/KS-γ Large
MDI AseptiCap® KL/KS- γ are gamma sterilizable disposable PES membrane capsule filters offering a convenient lab scale solutions for process development with identical materials of construction for easy scale up to pilot scale and finally production scale 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 EO gas or autoclaving
Sterile Filtration of:
- Cell culture media
- Cell culture media containing serum
- Media additives
- pH adjusters
- Final product concentrates
Bioburden Reduction/ Particulate Removal:
- Buffers
- Centrifuge supernatants
- Clarified cell lysates
| Construction | |||||
| Membrane | 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 |
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| Effective Filtration Area (Nominal) |
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| Dimensions (End to End) – 1½” Sanitary Flange I/O |
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| Dimension (End to End) – 1½” Sanitary Flange Inlet ½” Hose Barb Outlet |
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| Dimension (End to End) – ¾” Sanitary Flange I/O |
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| Dimensions (End to End) – ½” Single Step Hose Barb I/O |
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| Dimension (End to End) – 1″ Hose Barb I/O |
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| Operational Radius (with Vent/ Drain) |
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| Dimension (End to End) – 3/8″ Hose Barb I/O |
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| Vent and Drain |
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| Integrity Testing / Retention | |||||
| Bubble Point | > 50psi (3.52Kg/cm²)with Water | ||||
| Max. Air Diffusion Flows (10″) |
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| 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 as per USP <85> | ||||
| 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> | ||||
| 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 | ||||
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* Gamma sterilized filters cannot be gamma irradiated again
**1″ Hose Barb and 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
| LKSX | 54 | 01 | EE | R | X | 1 | 01 |
Example for Non Sterile: LKS55301QQRX101 Example for Gamma Sterile: LKS55301QQXX301
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