Sterile Opticap Disposable Capsules with Hydrophilic Durapore Membrane

Description

Sterile Opticap capsule filters are fully contained capsule filters with Durapore 0.22 µm or 0.1 µm hydrophilic PVDF membrane. The filters are sterilized by gamma irradiation prior to shipment, eliminating the need for autoclaving prior to use. They are available with a variety of inlet and outlet fittings to suit any sterile filtration application from ten to thousands of liters.

Overall process efficiency and cost effectiveness is enhanced due to the elimination of sterilization and associated validation issues.

The hydrophilic Durapore membrane provides high flow rate and throughput, low extractables and particle shedding, low protein adsorption, and broad chemical compatibility.

Sterile Opticap filters are supplied double bagged. The outer bag is designed with an easy-open feature to facilitate handling in a prep area. The inner bag is designed with a “header” to facilitate aseptic handling and connections.

For traceability and easy identification, each sterile Opticap filter is labeled with its catalogue number, lot number, serial number, and pore size. A gamma radiation indicator label, which turns red upon exposure, is provided with each unit as evidence of sterilization.

Typical Applications

Sterile Opticap capsules are suitable for sterile filtration of aqueous feed streams such as:

• Parenterals
  
• Biologicals
  
• Vaccines
  
• Media
  
• Buffer

Sterility Assurance

Sterile Opticap filters are manufactured with sterilizing grade Durapore membrane. Membrane samples are tested for bacterial retention prior to device manufacture. Samples of final devices are tested for retention per ASTM F838-83. Each filter is integrity tested during manufacturing with a test correlated to bacterial retention.

Product sterility is assured by gamma irradiation at ≥ 25 kGray, a minimum dose confirmed effective per AAMI guidelines.