|Sterilizing-grade Durapore® 0.22 µm Hydrophobic Filters|
|Sterile Filtration of Gases by Membrane Filters|
Leahy, Timothy J., and Raymond Gabler
Vol. XXVI: 836-843. 1984
|Opticap® XL Capsules and Opticap® XLT Capsules|
Hydrophobic Durapore® 0.22 µm Optiseal® Cartridge FiltersReliable filters for the sterile filtration of gases and liquids. Featuring a unique cartridge-to-housing sealing mechanism, these Optiseal Durapore cartridges offer maximum sterility assurance.
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Hydrophobic Durapore® 0.22 µm Cartridge FiltersReliable filters for the sterile filtration of gases and liquids
Learn More >>
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|Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore|
Reliable filters for the sterile filtration of gases and liquids
Durapore hydrophobic membrane cartridges and capsules are sterilizing-grade filters that provide sterility assurance, high flow rates and high throughput. They are used for sterile tank and gas venting, as well as for the filtration of liquids in small and large volume systems. Durapore 0.22 µm hydrophobic polyvinylidene fluoride (PVDF) membrane reliably eliminates contaminants and microorganisms in sterilizing applications, even at high pH.
Opticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. The capsule patented design allows unparalleled thermal and hydraulic stress resistance, resulting in reliability, high confidence in the sterility process and improved cleanliness.
Filters with hydrophobic Durapore 0.22 µm 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 capsule filter is integrity tested during manufacturing and is supported by a comprehensive Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each filter is labeled with the product name and identifying characteristics.
Multiple Formats Available
Opticap XL capsule filters with hydrophobic Durapore membrane are available in multiple filtration areas, providing an optimal choice for every application.
|Opticap XL 5||Opticap XL 10|
|Filtration Area||0.35 m²||0.69 m²|
|Materials of Construction|
|Filter media||Polyvinylidene Fluoride (PVDF)||Polyvinylidene Fluoride (PVDF)|
|Vent O-ring||Silicone (SI)||Silicone (SI)|
|Vent/Drain||1/4 in. Hose Barb with double O-ring Seal||1/4 in. Hose Barb with double O-ring Seal|
|Bubble Point at 23 °C||≥1170 mbar (17 psig) nitrogen with 60/40 % IPA/water||≥1240 mbar (18 psig) nitrogen with 60/40 % IPA/water|
|Nitrogen Diffusion at 23 °C||≤5 mL/min @ 1.7 bar (25 psig) in 60/40 % IPA/water||≤10 mL/min @ 1.7 bar (25 psig) with 60/40 % IPA/water|
|Maximum Inlet Pressure, bar (psi)||5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C|
|Maximum Differential Pressure, bar (psid)||Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 3.4 bar (50 psid) @ 25 °C, intermittent|
|Bacterial Endotoxins||Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test|
|Bacterial Retention||Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.|
|Sterilization||20 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable|
|Component Material Toxicity||Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction.|
|Good Manufacturing Practices||These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.|
|Non-Fiber Releasing||Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6).|
|European Pressure Equipment Directive||EMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.|
Typical Air Flow Rate versus Pressure Drop
Typical Liquid Flow Rate versus Pressure Drop
Opticap XL Capsule Connection Types
TT = 38 mm (11/2 in.) sanitary flange inlet and outlet
FF = 19 mm (3/4 in.) sanitary flange inlet and outlet
HH = 14 mm (9/16 in.) hose barb inlet and outlet