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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" Disposable
Capsules		10" Disposable
Capsules
Materials of Construction
FilterHydrophilic PVDFHydrophilic PVDF
SupportsPolyester; film edge HDPEPolyester; film edge HDPE
CapsuleGamma-stable polypropyleneGamma-stable polypropylene
Filtration Area, m20.160.73
Maximum Inlet Pressure, bar (psid)5.5 (80) @ 23 °C; 2.8 (40) @ 60 °C; 1.0 (15) @ 80 °C
Bacterial RetentionQuantitative 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 a 500 mL flush and 24-h soak in water at 25 °C≤25 mg after a 1 L flush and 24-h soak in water at 25 °C
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≤500 mL
ToxicityComponent 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.
SterilizationShipped 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 @ 2.75 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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Ordering Information  (return to top)

Select up to 5 products to compare them side by side
Sterile Opticap filters with 0.22 µm Hydrophilic Durapore Membrane · 4-inch Capsules

Compare Catalogue No. Connections, Inlet/Outlet  
KVGLS4FF3 19 mm (3/4 in.) Sanitary Flange » Add to Cart
KVGLS4FH3 19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb » Add to Cart
KVGLS4HH3 14 mm (9/16 in.) Hose Barb » Add to Cart
KVGLS4TH3 38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb » Add to Cart
KVGLS4TT3 38 mm (1-1/2 in.) Sanitary Flange » Add to Cart
4-inch Opticap filters are packaged 3 units per box.
Sterile Opticap filters with 0.22 µm Hydrophilic Durapore Membrane · 10-inch Capsules

Compare Catalogue No. Connections, Inlet/Outlet  
KVGLS1FF1 19 mm (3/4 in.) Sanitary Flange » Add to Cart
KVGLS1FH1 19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb » Add to Cart
KVGLS1HH1 14 mm (9/16 in.) Hose Barb » Add to Cart
KVGLS1TH1 38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb » Add to Cart
KVGLS1TT1 38 mm (1-1/2 in.) Sanitary Flange » Add to Cart
10-inch Opticap filters are packaged 1 unit per box.
Sterile Opticap filters with 0.1 µm Hydrophilic Durapore Membrane · 4-inch Capsules

Compare Catalogue No. Connections, Inlet/Outlet  
KVVLS4FF3 19 mm (3/4 in.) Sanitary Flange » Add to Cart
KVVLS4FH3 19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb » Add to Cart
KVVLS4HH3 14 mm (9/16 in.) Hose Barb » Add to Cart
KVVLS4TH3 38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb » Add to Cart
KVVLS4TT3 38 mm (1-1/2 in.) Sanitary Flange » Add to Cart
4-inch Opticap filters are packaged 3 units per box.
Sterile Opticap filters with 0.1 µm Hydrophilic Durapore Membrane · 10-inch Capsules

Compare Catalogue No. Connections, Inlet/Outlet  
KVVLS1FF1 19 mm (3/4 in.) Sanitary Flange » Add to Cart
KVVLS1FH1 19 mm (3/4 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb » Add to Cart
KVVLS1HH1 14 mm (9/16 in.) Hose Barb » Add to Cart
KVVLS1TH1 38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 in.) Hose Barb » Add to Cart
KVVLS1TT1 38 mm (1-1/2 in.) Sanitary Flange » Add to Cart
10-inch Opticap filters are packaged 1 unit per box.


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