Opticap XL Disposable Capsule Filters with Clarigard Media

Description

Clarigard® filters' 99.99% retention rating characteristic makes them ideal for the protection of critical downstream process steps such as membrane filters or chromatography columns. The graded-density depth structure of Clarigard filter media provides maximum filtration capacity, and the all-polypropylene construction offers low extractables levels and broad chemical compatibility.

Opticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. 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 with Clarigard media minimizes hold-up volume and reduces production losses.

Regulatory Compliance

Clarigard filters 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. Each Opticap™ XL capsule and cartridge filter 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

Opticap XL disposable capsule filters with Clarigard media are available in multiple filtration sizes, providing an optimal choice for every application.

Typical Applications

Precipitate Removal
Protein processing
Plasma fractions
Undissolved Constituent Removal
Cell culture media
Buffer salts
Ophthalmics
LVP/SVP
Carbon Fine Removal
Carbon beds in water processing
Powdered carbon in chemical synthesis
Gases
Dust, rust and other solids

Specifications

	Opticap XL 1	Opticap XL 5	Opticap XL 10
Materials of Construction
Filter medium	Polypropylene	Polypropylene	Polypropylene
Structural components	Polypropylene	Polypropylene	Polypropylene
O-rings	Silicone	Silicone	Silicone
Maximum Inlet Pressure, bar (psi)	5.5 (80) @ 23 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 80 ° C
Maximum Differential Pressure, bar (psid)	4.8 (70) @ 25 °C	4.8 (70) @ 25 °C	4.8 (70) @ 25 °C
Gravimetric Extractables	≤10 mg after 24-h soak in water	≤10 mg after 24-h soak in water	≤15 mg after 24-h soak in water
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L	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 ≥3 L
Bacterial Endotoxins	Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Sterilization	3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
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.
Non-Fiber Releasing	Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).
Indirect Food Additive	All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182.
European Pressure Equipment Directive	Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Equipment Directive, this product does not bear the CE mark.

Typical Clean Water Flow Rate vs Pressure Drop

Opticap XL Capsule Legends Refer to Connection Type:
T T = 38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet
FF = 19 mm (3/4 in.) Sanitary Flange Inlet and Outlet
HH = 14 mm (9/16 in.) Hose Barb Inlet and Outlet

Opticap XL 1 Capsule with Clarigard Media 0.2 µm Nominal (K002)

Opticap XL 5 Capsule with Clarigard Media 0.2 µm Nominal (K002)

Opticap XL 10 Capsule with Clarigard Media 0.2 µm Nominal (K002)

Opticap XL 1 Capsule with Clarigard Media 0.3 and 0.5 µm Nominal (K003, K005)

Opticap XL 5 Capsule with Clarigard Media 0.3 and 0.5 µm Nominal (K003, K005)

Opticap XL 10 Capsule with Clarigard Media 0.3 and 0.5 µm Nominal (K003, K005)

Opticap XL 1 Capsule with Clarigard Media 1.0 µm Nominal (K010)

Opticap XL 5 Capsule with Clarigard Media 1.0 µm Nominal (K010)

Opticap XL 10 Capsule with Clarigard Media 1.0 µm Nominal (K010)

Opticap XL 1 Capsule with Clarigard Media 3.0 µm Nominal (K030)

Opticap XL 5 Capsule with Clarigard Media 3.0 µm Nominal (K030)

Opticap XL 10 Capsule with Clarigard Media 3.0 µm Nominal (K030)

Compare	Catalogue No.	Nominal Pore Size (µm)	Connections, Inlet/Outlet
	K002A51FF1	0.2	19 mm (3/4 in.) Sanitary Flange
	K002A51HH1	0.2	14 mm (9/16 in.) Hose Barb
	K002A51TT1	0.2	38 mm (1-1/2 in.) Sanitary Flange
	K003A51FF1	0.3	19 mm (3/4 in.) Sanitary Flange
	K003A51HH1	0.3	14 mm (9/16 in.) Hose Barb
	K003A51TT1	0.3	38 mm (1-1/2 in.) Sanitary Flange
	K005A51FF1	0.5	19 mm (3/4 in.) Sanitary Flange
	K005A51HH1	0.5	14 mm (9/16 in.) Hose Barb
	K005A51TT1	0.5	38 mm (1-1/2 in.) Sanitary Flange
	K010A51FF1	1.0	19 mm (3/4 in.) Sanitary Flange
	K010A51HH1	1.0	14 mm (9/16 in.) Hose Barb
	K010A51TT1	1.0	38 mm (1-1/2 in.) Sanitary Flange
	K030A51FF1	3.0	19 mm (3/4 in.) Sanitary Flange
	K030A51HH1	3.0	14 mm (9/16 in.) Hose Barb
	K030A51TT1	3.0	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Nominal Pore Size (µm)	Connections, Inlet/Outlet
	K002A05FF1	0.2	19 mm (3/4 in.) Sanitary Flange
	K002A05HH1	0.2	14 mm (9/16 in.) Hose Barb
	K002A05TT1	0.2	38 mm (1-1/2 in.) Sanitary Flange
	K003A05FF1	0.3	19 mm (3/4 in.) Sanitary Flange
	K003A05HH1	0.3	14 mm (9/16 in.) Hose Barb
	K003A05TT1	0.3	38 mm (1-1/2 in.) Sanitary Flange
	K005A05FF1	0.5	19 mm (3/4 in.) Sanitary Flange
	K005A05HH1	0.5	14 mm (9/16 in.) Hose Barb
	K005A05TT1	0.5	38 mm (1-1/2 in.) Sanitary Flange
	K010A05FF1	1.0	19 mm (3/4 in.) Sanitary Flange
	K010A05HH1	1.0	14 mm (9/16 in.) Hose Barb
	K010A05TT1	1.0	38 mm (1-1/2 in.) Sanitary Flange
	K030A05FF1	3.0	19 mm (3/4 in.) Sanitary Flange
	K030A05HH1	3.0	14 mm (9/16 in.) Hose Barb
	K030A05TT1	3.0	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Nominal Pore Size (µm)	Connections, Inlet/Outlet
	K002A10FF1	0.2	19 mm (3/4 in.) Sanitary Flange
	K002A10HH1	0.2	14 mm (9/16 in.) Hose Barb
	K002A10TT1	0.2	38 mm (1-1/2 in.) Sanitary Flange
	K003A10FF1	0.3	19 mm (3/4 in.) Sanitary Flange
	K003A10HH1	0.3	14 mm (9/16 in.) Hose Barb
	K003A10TT1	0.3	38 mm (1-1/2 in.) Sanitary Flange
	K005A10FF1	0.5	19 mm (3/4 in.) Sanitary Flange
	K005A10HH1	0.5	14 mm (9/16 in.) Hose Barb
	K005A10TT1	0.5	38 mm (1-1/2 in.) Sanitary Flange
	K010A10FF1	1.0	19 mm (3/4 in.) Sanitary Flange
	K010A10HH1	1.0	14 mm (9/16 in.) Hose Barb
	K010A10TT1	1.0	38 mm (1-1/2 in.) Sanitary Flange
	K030A10FF1	3.0	19 mm (3/4 in.) Sanitary Flange
	K030A10HH1	3.0	14 mm (9/16 in.) Hose Barb
	K030A10TT1	3.0	38 mm (1-1/2 in.) Sanitary Flange

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