Sterile Opticap Disposable Capsules with Hydrophilic Durapore Membrane
Sterile Opticap capsule filters are fully contained capsule filters with Durapore 0.22 µm or 0.1 µm hydrophilic PVDF 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.
Sterile Opticap capsule filters are fully contained capsule filters with Durapore 0.22 µm or 0.1 µm hydrophilic PVDF 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.
規格說明 ：
Coming Soon - Opticap XL
An Industry Standard is Made Even Better
● New sizes in a single uniform design; Opticap XL 2, 4, 5 and 10 inch
● A more durable and robust housing structure
● Unparalleled thermal and hydraulic stress resistance
● Improved vent design for ease of use
● Scalable
|
4" Disposable Capsules |
10" 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 | 0.16 | 0.73 |
| Maximum Inlet Pressure, bar (psid) | 5.5 (80) @ 23 °C; 2.8 (40) @ 60 °C; 1.0 (15) @ 80 °C | |
| Bacterial Retention | Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. | |
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | |
| NVR Gravimetric Extractables | The extractables level was equal to or less than 10 mg after a 500 mL flush and 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 25 mg after a 1 L flush and 24 hours in water at controlled room temperature. |
| 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 irradiation @ >25 kGray gamma exposure | |
| 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 @ 2.75 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 | |
Coming Soon - Opticap XL
An Industry Standard is Made Even Better
● New sizes in a single uniform design; Opticap XL 2, 4, 5 and 10 inch
● A more durable and robust housing structure
● Unparalleled thermal and hydraulic stress resistance
● Improved vent design for ease of use
● Scalable
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