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Gamma Compatible Sterilizing-grade Durapore® 0.1 µm and 0.22 µm Filters

Superior Filters for the Sterile Filtration of Biopharmaceutical Liquids

Millipore gamma compatible capsule filters combine easy to use disposable technology with proven 0.1µm and 0.22 µm Durapore membrane.

Opticap™ XL and XLT capsules are designed to meet the growing demand for filtration into large sterile biocontainers. Up to 2000 liters of buffer, media and chromatographic eluents can be processed with these capsules. Millipak® disposable filter units are ideal for small volume processing and sterile fill and finish applications.

These disposable capsule filters are convenient, safe and supported by Millipore Validation Guides. Overall process efficiency and cost effectiveness are enhanced due to the elimination of cleaning and subsequent validation issues. The hydrophilic Durapore membrane provides high flow rates and throughput, low extractables and particle shedding, and broad chemical compatibility.

Regulatory Compliance

Filters with hydrophilic Durapore membrane 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 Millipak, Opticap XL and Opticap XLT capsule is integrity tested during manufacturing and is supported by a Validation Guide for compliance with regulatory requirements.

For traceability and easy identification, each device is marked with the product name and identifying characteristics.

Multiple Formats Available

Sterilizing-grade hydrophilic Durapore membranes are available in four formats, two pore sizes, and multiple configurations that vary by filtration area and type of inlet/outlet connection. We have a format to meet your application needs.

Millipak Low-Volume Capsule Filters

Millipak filters with hydrophilic Durapore membranes are uniquely designed for the removal of particles and micro-organisms. The stacked disc design allows minimal hold-up volume and no particle shedding, making Millipak units ideally suited for high value-added applications. Each Millipak filter is integrity tested during the manufacturing process.

Millipak filters are available in two different stack sizes. Adjustable, easy-to-turn, upstream vents and drain valves with O-ring seals and hose barb connections allow for easy process control.

Opticap XL and XLT Disposable Capsule Filters

Opticap XL and XLT 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 pleated Durapore membrane minimizes hold-up volume and reduces production losses.

Opticap XL 4, 5 and 10 capsule filters with hydrophilic Durapore membrane are available in multiple filtration areas, providing an optimal choice for every application.

Opticap XLT 10, 20 and 30 T-line Capsule Filters with hydrophilic Durapore membrane accommodate series or parallel filtration to match your application needs, and a specially-designed stand enables quick and easy integration into your existing process.

Opticap XL

Opticap XLT

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Specifications

	Millipak-100	Millipak-200
Filtration Area, cm²	500	1000
Materials of Construction
Filter membrane	Hydrophilic PVDF	Hydrophilic PVDF
Structural components	Polycarbonate	Polycarbonate
Vent caps	PVDF	PVDF
Housing Vent	Adjustable vent with male luer and female Luer-Lok™ connections on inlet side of device
Maximum Inlet Pressure, bar (psid)	5.2 (75) @ 25 °C	5.2 (75) @ 25 °C
Maximum Differential Pressure, bar (psid)	Forward: 4.1 (60) @ 25 °C; 1.7 (25) @ 80 °C; 0.35 (5) @ 123 °C. Reverse: 0.7 (10) @ 25 °C
Integrity Test
Bubble Point, 0.1 µm	≥4830 mbar (70 psig) air with water
Bubble Point, 0.22 µm	≥3450 mbar (50 psig) air with water
Gravimetric Extractables, mg	Maximum value after 200 mL flush and a 24 hour soak in ASTM® Type 1 reagent grade water at controlled room temperature:
	The extractables level was equal to or less than 2.5 mg per device after 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 5 mg per device after 24 hours in water at controlled room temperature.
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
Bacterial Endotoxins	Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC® 19146) per ASTM F838-83 methodology
Sterilization	3 autoclave cycles of 90 min @ 123 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; not in-line steam sterilizable
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.
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices.
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.

	Opticap XL 4	Opticap XL 10	Opticap XLT 10	Opticap XLT 20	Opticap XLT 30
Filtration Area, m²	0.18	0.73	0.73	1.45	2.17
Materials of Construction
Filter media	Hydrophilic PVDF
Film edge	Polyethylene
Supports	Polyester
Structural components	Gamma-stable polypropylene
Vent O-ring	Silicone
Vent/Drain	1/4 in. hose barb with double O-ring seal
Integrity Test, Bubble Point
0.1 µm	≥4830 mbar (70 psig) air with water
0.22 µm	≥3450 mbar (50 psig) air with water
Integrity Test, Air Diffusion
0.1 µm	≤5.7 mL/min @ 3.9 bar (56 psig) in water	≤5.7 mL/min @ 3.9 bar (56 psig) in water	≤5.7 mL/min @ 3.9 bar (56 psig) in water	≤5.7 mL/min @ 3.9 bar (56 psig) in water	≤5.7 mL/min @ 3.9 bar (56 psig) in water
0.22 µm	≤4.6 mL/min @ 2.75 bar (40 psig) in water	≤4.6 mL/min @ 2.75 bar (40 psig) in water	≤4.6 mL/min @ 2.75 bar (40 psig) in water	≤4.6 mL/min @ 2.75 bar (40 psig) in water	≤4.6 mL/min @ 2.75 bar (40 psig) in water
Maximum Inlet Pressure, bar (psid)	5.5 (80) @ 23 °C; 2.8 (40) @ 60 °C; 1.0 (15) @ 80 °C
Maximum Differential Pressure, bar (psid)	Forward: 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 2.8 (40) @ 25 °C, intermittent
NVR Gravimetric Extractables		The extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 50 mg per capsule after 24 hours in water at controlled room temperature.	The extractables level was equal to or less than 75 mg per capsule after 24 hours in water at controlled room temperature.
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL	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 ≥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 ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta (ATCC® 19146) per ASTM F838-83 methodology
Sterilization	3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; not in-line steam sterilizable
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.
Good Manufacturing Practices	These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices.
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.

Typical Clean Water Flow Rate vs Pressure Drop

Millipak 100//200 Capsule Filter with 0.1 µm Hydrophilic Durapore Membrane

Millipak 100//200 Capsule Filter with 0.22 µm Hydrophilic Durapore Membrane

Opticap XL 10 Capsule Filters with 0.1 µm Hydrophilic Durapore Membrane

Opticap XL 10 Capsule Filters with 0.22 µm Hydrophilic Durapore Membrane

Opticap XLT 10 Capsule Filters with 0.1 µm Hydrophilic Durapore Membrane

Opticap XLT 10 Capsule Filters with 0.22 µm Hydrophilic Durapore Membrane

Opticap XLT 20 Capsule Filters with 0.1 µm Hydrophilic Durapore Membrane

Opticap XLT 20 Capsule Filters with 0.22 µm Hydrophilic Durapore Membrane

Opticap XLT 30 Capsule Filters with 0.1 µm Hydrophilic Durapore Membrane

Opticap XLT 30 Capsule Filters with 0.22 µm Hydrophilic Durapore Membrane

Compare	Catalogue No.	Connections, Inlet/Outlet
	MPVL20CF3	19 mm (3/4 in.) Sanitary Flange
	MPVL20CA3	14 mm (9/16 in.) Hose Barb
	MPVL20CL3	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	MPVL10CF3	19 mm (3/4 in.) Sanitary Flange
	MPVL10CA3	14 mm (9/16 in.) Hose Barb
	MPVL10CL3	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	MPGL20CF3	19 mm (3/4 in.) Sanitary Flange
	MPGL20CA3	14 mm (9/16 in.) Hose Barb
	MPGL20CL3	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	MPGL10CF3	19 mm (3/4 in.) Sanitary Flange
	MPGL10CA3	14 mm (9/16 in.) Hose Barb
	MPGL10CL3	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KVVLG04FF3	19 mm (3/4 in.) Sanitary Flange
	KVVLG04FH3	19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
	KVVLG04HH3	14 mm (9/16 in.) Hose Barb
	KVVLG04TH3	38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
	KVVLG04TT3	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KVGLG04FF3	19 mm (3/4 in.) Sanitary Flange
	KVGLG04FH3	19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
	KVGLG04HH3	14 mm (9/16 in.) Hose Barb
	KVGLG04TH3	38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
	KVGLG04TT3	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KVVLG10FF1	19 mm (3/4 in.) Sanitary Flange
	KVVLG10FH1	19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
	KVVLG10HH1	14 mm (9/16 in.) Hose Barb
	KVVLG10TH1	38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
	KVVLG10TT1	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KVGLG10FF1	19 mm (3/4 in.) Sanitary Flange
	KVGLG10FH1	19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
	KVGLG10HH1	14 mm (9/16 in.) Hose Barb
	KVGLG10TH1	38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb
	KVGLG10TT1	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KVVLG1TBB1	25 mm (1 in.) Hose Barb
	KVVLG1THH1	16 mm (5/8 in.) Hose Barb
	KVVLG1TTH1	38 mm (1-1/2 in.) Sanitary Flange/16 mm (5/8 in.) Hose Barb
	KVVLG1TTT1	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KVVLG2TBB1	25 mm (1 in.) Hose Barb
	KVVLG2THH1	16 mm (5/8 in.) Hose Barb
	KVVLG2TTH1	38 mm (1-1/2 in.) Sanitary Flange/16 mm (5/8 in.) Hose Barb
	KVVLG2TTT1	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KVVLG3TBB1	25 mm (1 in.) Hose Barb
	KVVLG3THH1	16 mm (5/8 in.) Hose Barb
	KVVLG3TTH1	38 mm (1-1/2 in.) Sanitary Flange/16 mm (5/8 in.) Hose Barb
	KVVLG3TTT1	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KVGLG1TBB1	25 mm (1 in.) Hose Barb
	KVGLG1THH1	16 mm (5/8 in.) Hose Barb
	KVGLG1TTH1	38 mm (1-1/2 in.) Sanitary Flange/16 mm (5/8 in.) Hose Barb
	KVGLG1TTT1	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KVGLG2TBB1	25 mm (1 in.) Hose Barb
	KVGLG2THH1	16 mm (5/8 in.) Hose Barb
	KVGLG2TTH1	38 mm (1-1/2 in.) Sanitary Flange/16 mm (5/8 in.) Hose Barb
	KVGLG2TTT1	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Connections, Inlet/Outlet
	KVGLG3TBB1	25 mm (1 in.) Hose Barb
	KVGLG3THH1	16 mm (5/8 in.) Hose Barb
	KVGLG3TTH1	38 mm (1-1/2 in.) Sanitary Flange/16 mm (5/8 in.) Hose Barb
	KVGLG3TTT1	38 mm (1-1/2 in.) Sanitary Flange

Compare	Catalogue No.	Description
	XLTSTAND1	Standard Opticap XLT Capsule Filter Stand

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