Opticap XL Disposable Capsule Filters with Lifegard Media

Description

Lifegard glass microfiber medium was designed for removal of deformable and non-deformable particles and microorganisms from liquids. Versatile depth-type products retain contaminants within the matrix of glass microfiber medium. The Lifegard media is used to achieve exceptional retention efficiency. Because of its high holding capacity, adsorptive removal properties and excellent wet strength, it is very well-suited for the clarification and prefiltration of serum, plasma proteins, gene therapy and other viscous biologicals.

The capsule patented design allows unparalleled thermal and hydraulic stress resistance, resulting in reliability, high confidence in the sterility process and improved cleanliness. The unique capsule design minimizes hold-up volume and reduces production losses.

Regulatory Compliance

Filters with Lifegard media are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard and are shipped with a Certificate of Quality for documentation accuracy. Each Opticap XL capsule is supported by a Validation Guide for compliance with regulatory requirements.

For traceability and easy identification, each filter is marked with identifying characteristics.

Multiple Formats Available

A wide range of filtration areas is available to fit all of your application needs for easy scale-up of your small volume filtration steps to larger, full-scale filtration processes.

Opticap XL capsule filters are supplied with a choice of inlet and outlet connections to optimize your filtration process.

The Filter of Choice in Plasma and Protein Serum Applications

Lifegard filters protect downstream sterile filters and chromatography columns while effectively removing contaminants and retaining valuable fractions of interest. These filters will remove colloids, aggregated and non-product proteins, lipids and other particles before downstream purification.

Specifications

	Opticap XL5	Opticap XL10
Materials of Construction
Filter Media	Borosilicate Glass Fiber	Borosilicate Glass Fiber
Supports	Polypropylene	Polypropylene
Structural Components	Polypropylene	Polypropylene
O-rings (vent for capsules)	Silicone	Silicone
Filtration Area, m²	0.19	0.46
Maximum Differential Pressure, bar (psid)	3.5 (50) @ 25 °C
Maximum Inlet Pressure, bar (psi)	5.5 (80) @ 23 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 80 ° C
Bacterial Endotoxins	Aqueous extraction contains ≤1.0 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test	Aqueous extraction contains ≤1.0 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Gravimetric Extractables
1.0 µm	≤105 mg after autoclaving and 24-h soak in water and 2 L flush	≤255 mg after autoclaving and 24-h soak in water and 5 L flush
2.0 µm	≤93 mg after autoclaving and 24-h soak in water and 2 L flush	≤225 mg after autoclaving and 24-h soak in water and 5 L flush
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L
Component Material Toxicity	Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.
Sterilization	3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices.
Indirect Food Additive	All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182.

Typical Water Flow Rate

Opticap XL 5 Capsule with Lifegard Media — 1.0 µm Nominal (KP15)

Opticap XL 5 Capsule with Lifegard Media — 2.0 µm Nominal (KP20)

Opticap XL 10 Capsule with Lifegard Media — 1.0 µm Nominal (KP15)

Opticap XL 10 Capsule with Lifegard Media — 2.0 µm Nominal (KP20)

Compare	Catalogue No.	Nominal Pore Size (µm)	Connections, Inlet/Outlet
	KP15A05FF1	1.0	19 mm (3/4 in.) Sanitary Flange
	KP15A05HH1	1.0	14 mm (9/16 in.) Hose Barb
	KP15A05TT1	1.0	38 mm (1-1/2 in.) Sanitary Flange
	KP20A05FF1	2.0	19 mm (3/4 in.) Sanitary Flange
	KP20A05HH1	2.0	14 mm (9/16 in.) Hose Barb
	KP20A05TT1	2.0	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Nominal Pore Size (µm)	Connections, Inlet/Outlet
	KP15A10FF1	1.0	19 mm (3/4 in.) Sanitary Flange
	KP15A10HH1	1.0	14 mm (9/16 in.) Hose Barb
	KP15A10TT1	1.0	38 mm (1-1/2 in.) Sanitary Flange
	KP20A10FF1	2.0	19 mm (3/4 in.) Sanitary Flange
	KP20A10HH1	2.0	14 mm (9/16 in.) Hose Barb
	KP20A10TT1	2.0	38 mm (1-1/2 in.) Sanitary Flange

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