Millipore - Opticap XL and XLT Disposable Capsule Filters with Multilayer Durapore 0.45/0.22 µm

Description

The combination of hydrophilic low protein binding 0.45 µm Durapore polyvinylidene fluoride (PVDF) membrane and sterilizing-grade 0.22 µm Durapore membrane in a single capsule is the superior choice for clean and sterile processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties. Sterilizing-grade, hydrophilic Multilayer Durapore 0.45/0.22 µm filters maximize process efficiency by providing high product recovery and extended throughput with low pressure drops.

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 pleated Durapore membranes minimizes hold-up volume and reduces production losses.

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 Opticap capsule filter 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 labeled with the product name and identifying characteristics.

Multiple Formats Available

Opticap XL 10 Capsule Filters are supplied with a choice of inlet and outlet connections to optimize your filtration process, including sanitary flanges which provide a high flow rate, fractional sanitary flanges and hose barbs.

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

Typical Applications

Hydrophilic Multilayer Durapore 0.45/0.22 µm filters are recommended for a wide range of pharmaceutical and biological liquid applications including: the filtration of therapeutics, vaccines, antibiotics, blood fractionations, bulk pharmaceutical and other downstream biotechnology processing solutions where protein binding must be minimized. Hydrophilic Multilayer Durapore filters are ideally suited to applications requiring high sterility assurance, high product purity and high product yield.

Specifications (return to top)

	Opticap XL10	Opticap XLT10	Opticap XLT20	Opticap XLT30
Filtration Area, m²	0.55	0.55	1.2	1.75
Materials of Construction
Filter	Hydrophilic PVDF	Hydrophilic PVDF	Hydrophilic PVDF	Hydrophilic PVDF
Supports	Polypropylene	Polypropylene	Polypropylene	Polypropylene
Structural Components	Polypropylene	Polypropylene	Polypropylene	Polypropylene
O-ring	Silicone	Silicone	Silicone	Silicone
Vent/Drain	1/4 in. hose barb with double silicone O-ring seal
Maximum Differential Pressure, bar (psid)	Forward: 5.5 (80) @ 25 °C; 1.1 (25) @ 80 °C. Reverse: 3.5 (50) @ 25 °C, intermittent
Bubble Point	≥3450 mbar (50 psig) air with water
Air Diffusion	≤10.8 mL/min @ 2.75 bar (40 psig) in water	≤10.8 mL/min @ 2.75 bar (40 psig) in water	≤21.6 mL/min @ 2.75 bar (40 psig) in water	≤32.4 mL/min @ 2.75 bar (40 psig) in water
TOC/Conductivity	Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: 16 liters at 25 °C	Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: 16 liters at 25 °C	Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: 32 liters at 25 °C	Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: 48 liters at 25 °C
Bacterial Retention	Quantitative retention of 10⁷ CFU/cm² Brevundimonas diminuta ATCC® 19146 per ASTM methodology.
Bacterial Endotoxins	<0.25 EU/mL as determined by the LAL test per 10 inch cartridge
Oxidizable Substances	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤1.5 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤1.5 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤3 L	Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤4.5 L
Sterilization	3 autoclave cycles of 60 min @ 126 °C; 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

Opticap XL 10 Capsule Filters 0.45/0.22 µm Hydrophilic Durapore

Opticap XLT 10 Capsule Filters 0.45/0.22 µm Hydrophilic Durapore

Opticap XLT 20 Capsule Filters 0.45/0.22 µm Hydrophilic Durapore

Opticap XLT 30 Capsule Filters 0.45/0.22 µm Hydrophilic Durapore

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
TH = 38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm ( 9/16 in.) Hose Barb Outlet
Opticap XLT Capsule Legends Refer to Connection Type
T T = 38 mm (11/2 in.) Sanitary Flange Inlet and Outlet
HH = 16 mm (5/8 in.) Hose Barb Inlet and Outlet
TH = 38 mm (11/2 in.) Sanitary Flange Inlet and 16 mm (5/8 in.) Hose Barb Outlet
BB = 25 mm (1 in.) Hose Barb Inlet and Outlet

Comparar	Número de catálogo	Conexões, Entrada/Saída
	KHGLA10FF1	19 mm (3/4 in.) Sanitary Flange	» Adicionar ao pedido
	KHGLA10HH1	14 mm (9/16 in.) Hose Barb	» Adicionar ao pedido
	KHGLA10TH1	38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb	» Adicionar ao pedido
	KHGLA10TT1	38 mm (1-1/2 in.) Sanitary Flange	» Adicionar ao pedido

Comparar	Número de catálogo	Conexões, Entrada/Saída
	KHGLA1THH1	16 mm (5/8 in.) Hose Barb	» Adicionar ao pedido
	KHGLA1TTH1	38 mm (1-1/2 in.) Sanitary Flange/16 mm (5/8 in.) Hose Barb	» Adicionar ao pedido
	KHGLA1TTT1	38 mm (1-1/2 in.) Sanitary Flange	» Adicionar ao pedido
	KHGLA1TBB1	25 mm (1 in.) Hose Barb	» Adicionar ao pedido

Comparar	Número de catálogo	Conexões, Entrada/Saída
	KHGLA2THH1	16 mm (5/8 in.) Hose Barb	» Adicionar ao pedido
	KHGLA2TTH1	38 mm (1-1/2 in.) Sanitary Flange/16 mm (5/8 in.) Hose Barb	» Adicionar ao pedido
	KHGLA2TTT1	38 mm (1-1/2 in.) Sanitary Flange	» Adicionar ao pedido
	KHGLA2TBB1	25 mm (1 in.) Hose Barb	» Adicionar ao pedido

Comparar	Número de catálogo	Conexões, Entrada/Saída
	KHGLA3THH1	16 mm (5/8 in.) Hose Barb	» Adicionar ao pedido
	KHGLA3TTH1	38 mm (1-1/2 in.) Sanitary Flange/16 mm (5/8 in.) Hose Barb	» Adicionar ao pedido
	KHGLA3TTT1	38 mm (1-1/2 in.) Sanitary Flange	» Adicionar ao pedido
	KHGLA3TBB1	25 mm (1 in.) Hose Barb	» Adicionar ao pedido

Comparar	Número de catálogo	Descrição
	XLTSTAND1	Standard Opticap XLT Capsule Filter Stand	» Adicionar ao pedido

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