Sterile Opticap Disposable Capsules with Hydrophilic Durapore Membrane

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.


Specifications    (return to top)

4 in. Disposable Capsules 10 in. Disposable Capsules Materials of Construction Filter Hydrophilic PVDF Hydrophilic PVDF Supports Polyester; film edge HDPE Polyester; film edge HDPE Capsule Gamma-stable Polypropylene Gamma-stable Polypropylene Filtration Area, m2 0.15 0.73 Maximum Inlet Pressure, bar (psid) 5.5 (80) @ 25 °C; 2.8 (40) @ 60 °C; 1.0 (15) @ 80 °C Bacterial Retention Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM F838-83 methodology Bacterial Endotoxins <0.5 EU/mL as determined by the LAL test NVR Gravimetric Extractables ≤10 mg after 24-h soak in water ≤25 mg after 24-h soak in water Oxidizable Substances Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤500 mL Toxicity Component materials meet the requirements of the USP Class VI Biological Test for Plastics. The cartridges also meet the requirements of the USP General (Mouse) Safety Test. Sterilization Shipped sterile by gamma radiation @ >25 kGray Integrity Test - 0.22 µm Units Bubble Point ≥3450 mbar (50 psig) air with water ≥3450 mbar (50 psig) air with water Air Diffusion   ≤14 mL/min @ 2.8 bar (40 psig) in water Integrity Test - 0.1 µm Units Bubble Point ≥4830 mbar (70 psig) air with water ≥4830 mbar (70 psig) air with water Air Diffusion   ≤21.1 mL/min @ 3.9 bar (56 psig) in water