0.2µm AseptiCap® KL/KS-γ Inline
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 | 0.2µm | ||
| Prefilter Pore Size | 0.8 µm, 0.65µm, 0.45µm | ||
| Support Layers | Polyester | ||
| Body and Core | Polypropylene | ||
| Size | |||
| Size |
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| Effective Filtration Area (Nominal) |
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| Dimension (End to End) – Female Luer Lock Inlet/ Male Luer Slip |
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| Dimension (End to End) – ¼” SHB |
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| Dimension (End to End) – ¾” Sanitary Flange Inlet I/O |
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| Operational Radius (with Vent/ Drain) |
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| Integrity Testing / Retention | |||
| Bubble Point | > 50psi (3.52Kg/cm²) with Water | ||
| Microbial Retention | LRV >7 for Brevundimonas diminuta(ATCC 19146) per cm² | ||
| Operational | |||
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| Hold-up Volume(with air purge) |
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| 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 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 500ml flush | ||
| Quality Management System | ISO-9001 Certified | ||
| USFDA | DMF No. 015554 | ||
0.2µm AseptiCap® KL/KS -γ (25mm)
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a: Gamma irradiated filters can not be gamma sterilized again
*Female Luer Lock is available as Inlet only
**Male Luer Slip is available as Outlet only
Example:
| IKSX | 06 | 01 | MN | R | X | 1 | 04 |
Example for Non Sterile: IKLX0601MNRX104 Example for Gamma Sterile: IKLX0601MNXX304
0.2µm AseptiCap® KL/KS- γ (50 mm)
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a: Gamma sterilized filters cannot be gamma irradiated again
*¼” Stepped Hose Barb and ¾” Sanitary Flange are available in filters with vent only
**¼” Single Step Hose Barb and Female luer lock is available in filters without vent only
Example:
| VKSX | 10 | 01 | SS | R | X | 1 | 02 |
Example for Non Sterile: VKSX1001BBRX102 Example for Gamma Sterile: VKSX1001BBXX302
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