Opticap XL Disposable Capsule Filters with 0.45 µm Durapore Membrane

Description

Hydrophilic 0.45 µm Durapore® polyvinylidene fluoride (PVDF) membrane provides low protein binding, high flow rates and high throughputs. Durapore 0.45 µm membrane contributes to clean processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties.

Opticap XL 2, 4, 5 and 10 disposable capsule filters with 0.45 µm hydrophilic Durapore membrane are available in multiple filtration areas, providing an optimal choice for every application. Each Opticap XL capsule is integrity tested during the manufacturing process.

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.

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 XL 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.

Typical Applications

Durapore 0.45 µm hydrophilic filters remove particles and microorganisms from aqueous liquid streams. These filters are ideally suited for large volume parenteral or ophthalmics manufacturing, where prefiltration is either unnecessary or already present at an earlier point in the process, or where protein binding must be minimized.