Durapore® 0.1 µm and 0.22 µm Capsule Filters
Sterilizing-grade 0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes are low protein binding and provide sterility assurance, high flow rates and throughputs.
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Sterilizing-grade 0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes are low protein binding and provide sterility assurance, high flow rates and throughputs. Menos
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Material Qualification Dossier
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| 1.0 |
Quality Management Dossier (Open Access)
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Operational Excellence Dossier
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FAQ
| Pergunta | Resposta |
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| What are the most common causes of filter clogging (air bubbles, particulates, surface tension, inappropriate filter size etc.)? | Trapped bubbles, particulates and improper sizing are all common causes of fitration issues. True filter clogging is caused by particulates. Hard particles will form a cake on the filter surface. This will generally slow the filtration but not necessarily block filtration becuase fluid can flow through the layer of hard particles and then through the filter. Deformable particles can compress across the filter pores, forming impermeable barriers to filtration. This type of problem is common with solutions containing proteins or lipids. |
| Do Opticaps come pre-sterilized? | Opticaps are available in three formats:
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Produtos e aplicações relacionadas
Famílias de produtos
Durapore® 0.1 µm and 0.22 µm Capsule FiltersSterile Opticap capsule filters are fully contained capsule filters with Durapore 0.22 µm or 0.1 µm hydrophilic PVDF membrane.Saiba mais >> |
Durapore® 0.1 µm and 0.22 µm Cartridge FiltersA trusted name in the industry for over 25 years, The Durapore membrane contributes to clean processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties.Saiba mais >> |
OptiScale® Capsule Filters for Aseptic Processing ApplicationsOptiScale® capsules, with a large variety of filtration media options, are a family of convenient, disposable filters ideal for media selection, process screening and scaling.Saiba mais >> |
Durapore® 0.1 µm and 0.22 µm Optiseal® Cartridge FiltersOptiseal cartridge filters feature a revolutionary cartridge-to-housing sealing mechanism and pleated configuration, resulting in maximum sterility assurance and economical performance.Saiba mais >> |
Durapore® 0.1 µm and 0.22 µm Gamma Compatible Capsule FiltersEnhanced process efficiency and cost-effectiveness from reduced cleaning and validation requirementsSaiba mais >> |
Description
A trusted name in the industry for over 25 years, Durapore® sterilizing-grade 0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes are low protein binding and provide sterility assurance, high flow rates and throughputs. The Durapore membrane contributes to clean processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties.
Opticap XL and XLT 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. The unique capsule design with pleated Durapore membrane minimizes hold-up volume and reduces production losses.
Regulatory Compliance
Filters with hydrophilic Durapore 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 Opticap XL and XLT capsule is integrity tested during manufacturing and is supported by a Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each device is marked with the product name and identifying characteristics.
Multiple Formats Available
Opticap XL 2, 4, 5 and 10 capsule filters with hydrophilic Durapore membrane are available in multiple filtration areas, providing an optimal choice for every application.
Opticap XLT 10, 20 and 30 T-line Capsule Filters with hydrophilic Durapore membrane accommodate series or parallel filtration to match your application needs, and a specially-designed stand enables quick and easy integration of the Opticap XLT into your existing process.
| Opticap XL 2 | Opticap XL 4 | Opticap XL 5 | Opticap XL 10 | |
| Filtration Area | 0.09 m² | 0.19 m² | 0.34 m² | 0.69 m² |
| Materials of Construction | ||||
| Filter media | Polyvinylidene Fluoride (PVDF) | |||
| Supports | Polypropylene | |||
| Structural components | Polypropylene | |||
| Vent O-ring | Silicone (SI) | |||
| Vent/Drain | 1/4 in. hose barb with double O-ring seal | |||
| Integrity Test, Bubble Point | ||||
| 0.1 µm | ≥4830 mbar (70 psig) air with water | |||
| 0.22 µm | ≥3450 mbar (50 psig) air with water | |||
| Integrity Test, Diffusion | ||||
| 0.1 µm | — | ≤7.5 mL/min @ 3.9 bar (56 psig) in water | ≤10 mL/min @ 3.9 bar (56 psig) in water | ≤20 mL/min @ 3.9 bar (56 psig) in water |
| 0.22 µm | — | ≤5.5 mL/min @ 2.75 bar (40 psig) in water | ≤6.6 mL/min @ 2.75 bar (40 psig) in water | ≤13.3 mL/min @ 2.75 bar (40 psig) in 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: 3.5 bar (50 psid) @ 25 °C, intermittent | |||
| NVR Gravimetric Extractables | The extractables level was equal to or less than 10 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 10 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 15 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 25 mg per capsule after 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 | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L |
| Bacterial Endotoxins | Aqueous extraction contains <0.5 EU/mL as determined by the LAL test | |||
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology | |||
| Sterilization | 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable | |||
| Toxicity | Non-toxic per MEM elution ISO® 10993-5 | |||
| 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). | |||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | |||
| Opticap XLT 10 | Opticap XLT 20 | Opticap XLT 30 | ||
| Filtration Area | 0.69 m² | 1.4 m² | 2.1 m² | |
| Materials of Construction | ||||
| Filter media | Polyvinylidene Fluoride (PVDF) | |||
| Supports | Polypropylene | |||
| Structural components | Polypropylene | |||
| Vent O-ring | Silicone (SI) | |||
| Vent/Drain | 1/4 in. hose barb with double O-ring seal | |||
| Integrity Test, Bubble Point @ 23 °C | ||||
| 0.1 µm | ≥4830 mbar (70 psig) air with water | |||
| 0.22 µm | ≥3450 mbar (50 psig) air with water | |||
| Integrity Test, Air Diffusion @ 23 °C | ||||
| 0.1 µm | ≤20 mL/min @ 3.9 bar (56 psig) in water | ≤40 mL/min @ 3.9 bar (56 psig) in water | ≤60 mL/min @ 3.9 bar (56 psig) in water | |
| 0.22 µm | ≤13.3 mL/min @ 2.75 bar (40 psig) in water | ≤26.6 mL/min @ 2.75 bar (40 psig) in water | ≤40 mL/min @ 2.75 bar (40 psig) in 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; 1.7 bar (25 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent | |||
| NVR Gravimetric Extractables | The extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 50 mg per capsule after 24 hours in water at controlled room temperature. | The extractables level was equal to or less than 75 mg per capsule after 24 hours in water at controlled room temperature. | |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L | |
| Bacterial Endotoxins | Aqueous extraction contains <0.5 EU/mL as determined by the LAL test | |||
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology | |||
| Sterilization | 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable | |||
| Toxicity | Non-toxic per MEM elution ISO® 10993-5 | |||
| 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). | |||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | |||
Typical Clean Water Flow Rate vs Pressure Drop
Opticap® XL 2 Capsule Filters with 0.1 µm Hydrophilic Durapore® (KVVL)
Opticap® XL 2 Capsule Filters with 0.22 µm Hydrophilic Durapore® (KVGL)
Opticap® XL 4 Capsule Filter with 0.1 µm Hydrophilic Durapore® (KVVL)
Opticap® XL 4 Capsule Filters with 0.22 µm Hydrophilic Durapore® (KVGL)
Opticap® XL 5 Capsule Filters with 0.1 µm Hydrophilic Durapore® (KVVL)
Opticap® XL 5 Capsule Filters with 0.22 µm Hydrophilic Durapore® (KVGL)
Opticap® XL 10 Capsule Filters with 0.1 µm Hydrophilic Durapore® (KVVL)
Opticap® XL 10 Capsule Filters with 0.22 µm Hydrophilic Durapore® (KVGL)
Opticap® XLT 10 Capsule Filters with 0.1 µm Hydrophilic Durapore® (KVVL)
Opticap® XLT 10 Capsule Filters with 0.22 µm Hydrophilic Durapore® (KVGL)
Opticap® XLT 20 Capsule Filters with 0.1 µm Hydrophilic Durapore® (KVVL)
Opticap® XLT 20 Capsule Filters with 0.22 µm Hydrophilic Durapore® (KVGL)
Opticap® XLT 30 Capsule Filters with 0.1 µm Hydrophilic Durapore® (KVVL)
Opticap® XLT 30 Capsule Filters with 0.22 µm Hydrophilic Durapore® (KVGL)
Opticap XL Capsule Legends Refer to Connection Type:
TT = 38 mm (1 1/2 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
TH = 38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet
FH = 19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet