AseptiSure HSR Mini 2.5", 5"
mdi AseptiSure HSR Polyethersulfone (PES) membrane mini cartridge filters type AseptiSure HSR are designed to withstand high pressure differential upto 0.3 Kg/cm² (5 psi) at high steam sterilization temperatures of up to135 °C.
These filters with Polyethersulfone membrane and Polypropylene support layers offer pH compatibility from 1 to14, and are thus ideal for use with acidic as well as alkaline solutions.
mdi AseptiSure HSR Mini Cartridge filters are validated for key performance parameters such as retention efficiency, chemical compatibility, extractables, heat stability and flow rates.
- Low protein binding
- High throughputs
- Long service life
- Non-toxic material of construction
- Heat sealed, no glues or adhesives
- Each filter comes with an individualcertificate of quality
- Total traceability: Unique Identification number is laseretched on each filter
- Sterile Filtration of Culture media for mammalian cell culture
Construction | |||
Membrane | Polyethersulfone | ||
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Support Layers | Polypropylene | ||
Body and Core | Polypropylene | ||
Integrity Testing / Retention | |||
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Microbial Retention |
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Size | |||
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Operational | |||
Max. Operating Temperature | 80 °C @ < 2 Kg/cm² (30 psi) | ||
Max. Differential Pressure | 3.5 Kg/cm² (50 psi) @ 25 °C | ||
Reverse Pressure | < 0.7 Kg/cm² (10 psi) @ 25 °C | ||
Sterilization | Autoclave/In-line steam sterilization cycles at 135°C for 30 min., ∆p=5 psi (0.3kg/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 | Passes USP test for particulates 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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* 0.45µm cartridge filter are available with 0.65µm or 0.8µm upstream layer only
**G0 adapter code is not available with any elastomer. Please mention XX in place of elastomer code while ordering
***Adapter code F0 is available only in 5” cartridge filters
Example :
CHRX | 50 | 01 | E0 | SS | 1 | 01 |
Datasheet | Download |