Consistent and Reliable Quality:	AseptiCap capsule filters are produced with ISO 9001-2008 certified quality  management systems.
	Regulatory Compliance:	Meet all pharmacopeial and compendia requirements and are registered with USFDA DMF #15554
	Low Protein Binding:	Results in increased overall product yield and higher throughputs with biological streams.
	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.

Sterile Filtration of:

• Cell culture media
  
• Cell culture media containing serum
  
• Media additives
• Final product concentrates

Construction Pore size 0.1µm Membrane 0.1 μm Hydrophilic PES Prefilter Membrane 0.45 μm Hydrophilic PES Size 10" EFA (Effective Filtration Area) 6000cm² Support Layers Polyester Body and Core Gamma Stable Polypropylene Dimension (End to End) 1½" Sanitary  Flange 332 mm ½" HB 337 mm Operational Radius (with Vent/ Drain) 78 mm Vent and Drain 1/4" Hose Barb with double Silicone "O" rings Operational Max. Operating Temperature 80 °C @ < 30 psi (< 2 Kg/cm²) Max. Differential Pressure 60 psi (4 Kg/cm²) @ 30 °C Bubble Point > 35psi (2.46Kg/cm²) with 50% IPA/water solution Sterilization By Irradiation Gamma Irradiatable up to 50 kGy By Gas Sterilizable by Ethylene Oxide By Autoclave Autoclavable at 121°C for 30minute, 3 Cycles. Can not be steam sterilized Assurance Toxicity Passes Bioreactivity test, In Vivo, as per USP for Class VI plastics Cytotoxicity Passes Biological Reactivity Tests, in vitro, USP <87> for cytotoxicity Bacterial Retention LRV> 7 for B. diminuta per cm² of filter area as per ASTM F 838-05 Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus  Amebocyte Lysate (LAL) Test Non Fiber Releasing Passes test as per USP and comply with USFDA 21 CFR Part 211.72 for fiber release pH Compatibility Compatible with pH range of 1 - 10 Extractables with WFI Passes test as per USP Fractional Dissolution Comply with USFDA 21 CFR Part 177.1520 Oxidizable Substances Within limits as specified in USP Quality Management System ISO-9001:2008 Certified USFDA DMF Type V No. 15554

Type LKS LKSX   Size Size Code 10" 54   Pore Size Pore Size Code 0.1µm 36   I/O Connection Connection Code ½”Hose Barb D 1½" Sanitary Flange E   Radiation Sterilizable Code Yes R   x   Sterile/ Non Sterile Code Non Sterile 1   Pack Size Pack Size Code 12 08

LKSX 54 36 EE R X 1 01