0.1μm AseptiPrime KS 5", 10", 20", 30"
mdi AseptiPrime KS are sterilizing grade PES membrane cartridge filters specially designed for very high throughputs.The special optimized pre -filter membrane layer offers high loading and volume handling capacities to provide enhanced protection to the final membrane layer.
These filters meet key process requirements such as high retention efficiency, very high protein recoveries,extremely low extractables, high throughputs , wide chemical compatibility etc.
- Absolute retention
- 100% integrity tested
- Low protein binding
- Low extractables
Sterile filtration of:
- Cell culture media
- Cell culture media containing serum
- Media additives
- Buffers
- pH adjusters
- Final product concentrates
| Construction | |||||
| Membrane | Hydrophilic Polyethersulfone | ||||
| Final Filter Pore Size | 0.1 µm | ||||
| Prefilter Pore Size |
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| Support Layers | Polyester | ||||
| Body and Core | Polypropylene | ||||
| Integrity Testing / Retention | |||||
| Bubble Point | > 31psi (2.18 Kg/cm²) with 50% IPA/Water Solution | ||||
| Microbial Retention | LR V >7 for Acholeplasma laidlawii (ATCC 23206) per cm² | ||||
| Air Diffusion Flow (10") |
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| Operational | |||||
| Max. Operating Temperature | 80°C @ < 30 psi (2 Kg/cm²) | ||||
| Max. Differential Pressure | 50 psi (3.5 Kg/cm²) @ 25°C | ||||
| Reverse Pressure | < 0.7 Kg/cm² (10 psi) @ 25 °C | ||||
| Sterilization | In-line steam sterilizable at 135°C for 30 minutes at a maximum differential pressure of 3 psi (0.21 kg/cm²), 25 cycles | ||||
| 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 test as per USP | ||||
| Good Manufacturing Practice | These products are manufactured in a facility which adheres to Good Manufacturing Practices. | ||||
| Oxidizable Substances | Within limits as specified in USP | ||||
| Particle Shedding | The filtrate Complies with USP <788> test for particulate matter in injectables | ||||
| TOC/Conductivity at 25 °C | Meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a specified volume of purified water flush | ||||
| Quality Management System | ISO-9001 Certified | ||||
| USFDA | DMF No. 015554 | ||||
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*Size 5" is available in Adapter Code A0 (7P) and A1 (7P without fin) only
**FV is available with Adapter code A0 (7P) and A1 (7P without fin) only
Example :
| CKH7 | 56 | 36 | A0 | SS | 1 | 01 |
| Datasheet | Download |