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

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 1.1 1.65 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; 1.7 (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 @ 2.8 bar (40 psig) in water ≤10.8 mL/min @ 2.8 bar (40 psig) in water ≤21.6 mL/min @ 2.8 bar (40 psig) in water ≤32.4 mL/min @ 2.8 bar (40 psig) in water TOC/Conductivity Autoclaved cartridges meet 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 cartridges meet 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 cartridges meet 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 cartridges meet 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 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