0.2µm AseptiCap LKS (with Prefilter)


	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.

Bioburden reduction from cell harvest supernatants
Filtration of equilibrating, washing and elution buffers for chromatography columns
Sterilization of biopharmaceuticals such as vaccines and therapeutic proteins
Sterilization of buffers
Sterilization of adjuvants

Construction
Pore size		0.2µm
Membrane		0.2 μm Hydrophilic PES
Prefilter Membrane		0.8 μm, 0.65µm or 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		> 50psi (3.52Kg/cm²) with water
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

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