Advanced Microdevices Pvt. Ltd. (mdi)
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- mdi AseptiCap - Capsule Filters
mdi AseptiCap - Capsule Filters
mdi AseptiCap KS are specially designed filters for process development and formulation development labs with identical materials of construction to larger capsule and cartridge filters for easy scale up. The 0.1µm rated PES membrane is validated for quick and efficient mycoplasma removal with enhanced throughtputs. 50mm Inline capsule filter is a specially vented device for use with peristaltic pump to ensure easy removal of entrapped air in the upstream.
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Sterile Filtration of:
- Cell culture media
- Cell culture media containing serum
- Media additives
- Final product concentrates
- Consistent and Reliable Quality: AseptiCap capsule filters are produced with ISO 9001 certified quality management systems
- Regulatory Compliance: Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #015554
- Low Protein Binding: Results in increased overall product yield
- High Throughputs: Translates to lower filtration costs, less number of filter changes and overall economy of operations
- Low Extractables: Mean less addition to impurity profile of the biological product from the filters
Construction
- Membrane : 0.1 μm Hydrophilic PES
- Prefilter Membrane : 0.2 μm or 0.45 μm Hydrophilic PES
- Plastic parts : Polypropylene
- Integrity Testing / Retention
- Bubble Point : > 31 psi (2.18 Kg/cm² ) with 50% IPA
- Bacterial Retention : LRV > 7 for Acholeplasma laidlawii ATCC 23206 per cm² of filter area
Size
- Size : 25 mm : 50 mm
- Effective Filtration Area (Nominal) : 5 cm² : 20 cm²
- Dimension (End to End) - Female Luer Lock Inlet/ Male Luer Slip : 23 mm : --
- Dimension (End to End) - ¾" Sanitary Flange Inlet I/O : -- : 51 mm
- Dimension (End to End) - ¼" SHB : -- : 79 mm
- Operational Radius (with Vent/ Drain) : 15 mm : 28 mm
Operational
- Max. Operating Temperature : 55 °C : 60 °C
- Max. Differential Pressure : 75 Psi (5 Kg/cm²)@ 25 °C : 42 Psi (3 Kg/cm²) @ 30 °C
- Burst Pressure : >14 Kg/cm² : >8 Kg/cm²
- Hold-up Volume(with air purge) : < 50 µL : < 300 µL
- pH Compatibility : Compatible with pH range of 1-14
- Sterilization By Gas : Sterilizable by Ethylene Oxide
- Sterilization By Autoclave : Autoclavable at 125°C for 30 minutes, 25 cycles and it cannot be in-line steam sterilized
- Shelf Life : 3 years after EO 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 ANSI/AAMI/ISO 11737-1 : 1995
- Non Fiber Releasing : Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
- TOC and Conductivity : Meets the WFI requirements of USP for TOC <643> and Conductivity <645> after a specified minimal flush
- Particle Release : Passes USP test for particulates in injections
- Indirect Food Additive : All Polypropylene components meet the FDA Indirect Food Additive requirements cited in 21 CFR Part 177.1520
- Extractables with WFI : Passes test as per USP
- Oxidizable Substances : Within limits as specified in USP
- Particle Shedding : Passes USP test for particulates in injectables.
- Quality Management System : ISO-9001 Certified
- USFDA : DMF No. 015554