Multilayer Durapore® 0.45/0.22 µm Cartridge Filters
Sterilizing grade, hydrophilic Multilayer Durapore 0.45/0.22 µm filters maximize process efficiency by providing high product recovery and extended throughput with low pressure drops.
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Sterilizing grade, hydrophilic Multilayer Durapore 0.45/0.22 µm filters maximize process efficiency by providing high product recovery and extended throughput with low pressure drops. Less
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Overview
Specifications
Ordering Information
Documentation
FAQ
| Question | Answer |
|---|---|
| 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. |
| What is the compatibility of Durapore with high pH solutions? | The upper recommended pH limit for Durapore membranes is 10. At pH >10, the hydrophilization layer of the membrane may become subject to hydrolysis. The extent of hydrolysis is a function of time, temperature , concentration and time of exposure. Upon exposure to high pH, the hydrophylization layer can swell which could result in a loss of permeability or flux. The hydrolysis of the hydrophilic layer will also lead to increased extractables from the membrane. |
| What are Millipore's general recommendations for filtering high pH solutions? | For applications involving pH > 10, Millipore recommends the use or our PES membranes Express SHF or Express SHC. For information on these filters : Express SHF: http://www.millipore.com/catalogue.nsf/docs/C8873 Express SHC: http://www.millipore.com/catalogue.nsf/docs/C9146 |
| How can I differentiate filter plugging due to air bubbles, particulates, surface tension, inappropriate filter size, etc.? | Air locking will occur when filtration is initiated without adequate venting or when air bubbles become trapped in fluid lines. Air will pass easily through a dry hydrophillic or hydrophobic filter. However, when a filter is wet and air is applied to a surface, the air will remain until it is manually moved upstream by venting or until the bubble point of the filter is reached. Bubble point is defined as the pressure at which gas displaces liquid for the largest set of filter pores and is able to flow through the pores. Air locking reduces the effective filtration area of the filter and thus reduces the flow rate. Surface tension refers to the strong cohesive forces present between molecules at the surface of a liquid. The higher the surface tension, the more force is required to force fluid through the membrane.. Innapropriate filter size will can cause a filter to plug prematurely. Filter pore size is chosen based on the application. If the application requires a sterile fluid, than a 0.22 micron membrane would be used for standard solutions that have bacterial bioburden. A 0.1 micron filter would be used for applications where mycoplasma is a concern. Where virus contamination is a concern, ultrafiltration would be required. The selection of a filter pore size that is smaller than that required for the application will cause a decrease in filter capacity and an increase in cost. |
User Guides
| Title |
|---|
| Hydrophilic Durapore® Cartridges and Capsules User Guide |
Related Products & Applications
Product Families
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.Learn More >> |
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Multilayer Durapore® 0.45/0.22 µm Capsule FiltersOpticap XL and XLT capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings.Learn More >> |
Related Products By: Application Facete
| Antibody Purification |
| Disinfection control |
| Dialysis and Filtration |
Related Products By: Brand Facete
| Durapore® |
Categories
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore |
Description
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 cartridge filter 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 labeled with the product name and identifying characteristics.
The combination of hydrophilic low protein binding 0.45 µm Durapore polyvinylidene fluoride (PVDF) membrane and sterilizing-grade 0.22 µm Durapore membrane in a single cartridge is the superior choice for clean and sterile processes due to low extractables, broad chemical compatibility, and its non-fiber releasing properties. Sterilizing-grade, hydrophilic Multilayer Durapore 0.45/0.22 µm filters maximize process efficiency by providing high product recovery and extended throughput with low pressure drops.
Hydrophilic Multilayer Durapore 0.45/0.22 µm cartridge filters provide high throughput with minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles.
Multiple Formats Available
A full range of filtration areas is available to suit varying application requirements and a variety of connection options are offered to meet your application and housing requirements.
Typical Applications
Hydrophilic Multilayer Durapore 0.45/0.22 µm filters are recommended for a wide range of pharmaceutical and biological liquid applications including: the filtration of therapeutics, vaccines, antibiotics, blood fractionations, bulk pharmaceutical and other downstream biotechnology processing solutions where protein binding must be minimized. Hydrophilic Multilayer Durapore filters are ideally suited to applications requiring high sterility assurance, high product purity and high product yield.
| OptiScale Capsules and Cartridge Filters | |||
| OptiScale 25 Capsules | OptiScale 47 Capsules | Cartridge Filters (per 10-inch element) | |
| Nominal Dimensions | |||
| Length: | 39 mm (1.52 in.) with female Luer-Lok inlet/male Luer-Lok outlet | 82 mm (3.24 in.) with flange inlet/hose barb outlet 74 mm (2.91 in.) with flange inlet/flange outlet 94 mm (3.70 in.) with hose barb inlet/hose barb outlet |
25.4 cm (10 in.) |
| Diameter: | 31 mm (1.21 in.) | 69 mm (2.75 in.) | 6.9 cm (2.7 in.) |
| Weight: | 0.19 oz (5.5 g) | (2.3 oz) (67 g) | — |
| Filtration Area | 3.5 cm² | 17.7 cm² | 0.55 m² (6.0 ft²) |
| Materials of Construction | |||
| Filter membrane: | Dual layer hydrophilic PVDF | ||
| Structural components*: | Polypropylene | Polycarbonate | Polypropylene |
| Supports: | Polypropylene | ||
| Vent caps: | Polypropylene | PVDF | — |
| O-rings: | Fluoroelastomers | Silicone | |
| Housing Vent | Capped vent with female Luer connections on inlet side of device. | Adjustable vent with male luer and female Luer-Lok connections on inlet side of the device | — |
| Maximum Inlet Pressure | 4.1 bar (60 psi) at 25 °C | 5.5 bar (80 psi) at 25 °C | — |
| Maximum Differential Pressure | |||
| Forward: | 4.1 bar (60 psi) at 25 °C | — | 5.5 bar (80 psid) at 25 °C, 1.75 bar (25 psid) at 80 °C, 345 mbar (5 psid) at 135 °C |
| Reverse: | 0 bar (0 psi) | — | 3.4 bar (50 psid) at 25 °C, intermittent |
| Bubble Point at 23 °C | — | ≥ 3450 mbar (50.0 psig) air with water | |
| Air Diffusion | — | — | Through a water wet membrane at 2.8 bar (40 psig) at ambient temperature: |
| ≤ 10.8 cc/min per 10-inch element | |||
| Bacterial Retention | — | — | Quantitative retention of 107 CFU/cm² Brevundimonas diminuta per ASTM F838-83 methodology. |
| Bacterial Endotoxin | Aqueous extraction contains < 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. | — | Aqueous extraction contains < 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. |
| TOC/Conductivity | This product exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS per USP <645> after autoclave and WFI water flush of 35 mL. | — | Autoclaved cartridges meet the requirements of USP <643> for Total Organic Compounds and USP <645> for Water Conductivity after a WFI water flush of 16 liters per 10-inch cartridge at 25 °C. |
| Oxidizable Substances | — | Effluent meets the USP Oxidizable Substance Test requirements for Sterile Purified Water after a water flush of: | |
| ≤ 100 mL. | ≤ 1500 mL per 10-inch element | ||
| Sterilization | May be autoclaved for 1 cycle of 60 min at 123 °C. | May be autoclaved for 3 cycles of 60 minutes at 126 °C. | May be autoclaved for 30 cycles of 60 minutes at 126 °C or steam sterilized up to 30 times for 30 minutes at 135 °C. |
| Good Manufacturing Practice | These products are manufactured in a Millipore facility which adheres to FDA Good Manufacturing Practices. | ||
| Non-Fiber Releasing | Durapore membrane meets criteria for a “non fiber releasing” filter as defined in 21 CFR 210.3 (b)(6). | ||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Sterilizing-grade Durapore filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | ||
| Indirect Food Additive | Durapore membrane meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All other component materials also meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182. | ||
| * Cage, core, end caps and capsule housing | |||
| Opticap XL and XLT Disposable Capsules (Autoclavable) | ||||
| Opticap (Model) | XL 10 | XLT 10 | XLT 20 | XLT 30 |
| Nominal Dimensions | ||||
| Maximum length: | 33.5 cm (13.2 in.) | 37.6 cm (14.8 in.) | 62.5 cm (24.6 in.) | 87.1 cm (34.3 in.) |
| Body diameter: | 10.7 cm (4.2 in.) | — | — | — |
| Fitting to Fitting | ||||
| Sanitary flange to sanitary flange: | — | 15.2 cm (6.0 in.) | ||
| Sanitary flange to hose barb: | — | 17.5 cm (6.9 in.) | ||
| Hose barb to hose barb: | — | 19.8 cm (7.8 in.) | ||
| Filtration Area | 0.60 m² (6.5 ft²) | 1.2 m² (13 ft²) | 1.81 m² (19.85 ft²) | |
| Materials of Construction | ||||
| Filter membrane: | Dual layer hydrophilic PVDF | |||
| Supports: | Polypropylene | |||
| Structural components*: | Polypropylene | |||
| Vent O-rings: | Silicone | |||
| Vent/Drain | ¼ in. hose barb with double O-ring seal | — | — | — |
| Maximum Inlet Pressure | 5.5 bar (80 psi) at 23 °C 2.8 bar (40 psi) at 60 °C 1.0 bar (15 psi) at 80 °C |
|||
| Maximum Differential Pressure | ||||
| Forward: | 5.5 bar (80 psid) at 25 °C, 1.05 bar (15 psid) at 80 °C | |||
| Reverse: | 3.5 bar (50 psid) at 25 °C, intermittent | |||
| Bubble Point at 23 °C | ≥ 3450 mbar (50.0 psig) air with water | |||
| Air Diffusion | Through a water wet membrane at 2.8 bar (40 psig) at ambient temperature: | |||
| ≤ 15.0 cc/min | ≤ 30.0 cc/min | ≤ 45.0 cc/min | ||
| TOC/Conductivity at 25 °C | Autoclaved cartridge meets the requirements of USP <643> for Total Organic Compounds and USP <645> for Water Conductivity after a WFI water flush of: | |||
| 36 L | 72 L | 108 L | ||
| Oxidizable Substances | Meets the USP Oxidizable Substances Test requirements for Sterile Purified Water after a water flush of: | |||
| ≤ 1500 mL | ≤ 3000 mL | ≤ 4500 mL | ||
| Bacterial Retention | Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC 19146 per ASTM methodology. | |||
| Bacterial Endotoxin | Aqueous extraction contains < 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | |||
| Gamma compatible: | Gamma compatible to 45 kGy. May be autoclaved for 3 cycles of 60 minutes at 123 °C (cannot be steam sterilized in-line). | |||
| Sterile capsules: | May be autoclaved for 3 cycles of 60 minutes at 126 °C (cannot be steam sterilized in-line). | |||
| Sterility (Sterile capsules only) | Meets current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle. | |||
| Good Manufacturing Practices | These products are manufactured in a Millipore facility which adheres to FDA Good Manufacturing Practices. | |||
| Non-Fiber Releasing | Durapore membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). | |||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Sterilizing-grade Durapore filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | |||
| Indirect Food Additive | The Durapore membrane used in these products meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All other component materials also meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182. | |||
| * Cage, core, end caps and capsule housing | ||||
| Opticap XL and XLT Disposable Capsules (Sterile and Gamma Compatible) | ||||
| Opticap (Model) | XL 10 | XLT 10 | XLT 20 | XLT 30 |
| Nominal Dimensions | ||||
| Maximum length: | 33.5 cm (13.2 in.) | 37.6 cm (14.8 in.) | 62.5 cm (24.6 in.) | 87.1 cm (34.3 in.) |
| Body diameter: | 10.7 cm (4.2 in.) | — | — | — |
| Fitting to Fitting | ||||
| Sanitary flange to sanitary flange: | — | 15.2 cm (6.0 in.) | ||
| Sanitary flange to hose barb: | — | 17.5 cm (6.9 in.) | ||
| Hose barb to hose barb: | — | 19.8 cm (7.8 in.) | ||
| Filtration Area | 0.60 m² (6.5 ft²) | 1.2 m² (13 ft²) | 1.81 m² (19.5 ft²) | |
| Materials of Construction | ||||
| Filter membrane: | Dual layer hydrophilic PVDF | |||
| Supports: | Polypropylene | |||
| Structural components*: | Polypropylene | |||
| Vent O-rings: | Silicone | |||
| Vent/Drain | ¼ in. hose barb with double O-ring seal | — | — | — |
| Maximum Inlet Pressure | 5.5 bar (80 psi) at 23 °C 2.8 bar (40 psi) at 60 °C 1.0 bar (15 psi) at 80 °C |
|||
| Maximum Differential Pressure | ||||
| Forward: | 5.5 bar (80 psid) at 25 °C, 1.75 bar (25 psid) at 80 °C | |||
| Reverse: | 3.5 bar (50 psid) at 25 °C, intermittent | |||
| Bubble Point at 23 °C |
≥ 3450 mbar (50.0 psig) air with water | |||
| Air Diffusion | Through a water wet membrane at 2.8 bar (40 psig) at ambient temperature: | |||
| ≤ 10.8 cc/min | ≤ 21.6 cc/min | ≤ 32.4 cc/min | ||
| TOC/Conductivity at 25 °C | Autoclaved cartridge meets the requirements of USP <643> for Total Organic Compounds and USP <645> for Water Conductivity after a WFI water flush of: | |||
| 16 L | 32 L | 48 L | ||
| Oxidizable Substances | Meets the USP Oxidizable Substances Test requirements for Sterile Purified Water after a water flush of: | |||
| ≤ 1500 mL | ≤ 3000 mL | ≤ 4500 mL | ||
| Bacterial Retention | Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC 19146 per ASTM methodology. | |||
| Bacterial Endotoxin | Aqueous extraction contains < 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | |||
| Gamma compatible: | Gamma compatible to 45 kGy. May be autoclaved for 3 cycles of 60 minutes at 123 °C (cannot be steam sterilized in-line). | |||
| Sterile capsules: | May be autoclaved for 3 cycles of 60 minutes at 126 °C (cannot be steam sterilized in-line). | |||
| Sterility (Sterile capsules only) | Meets current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle. | |||
| Good Manufacturing Practices | These products are manufactured in a Millipore facility which adheres to FDA Good Manufacturing Practices. | |||
| Non-Fiber Releasing | Durapore membrane meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6). | |||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. Sterilizing-grade Durapore filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | |||
| Indirect Food Additive | The Durapore membrane used in these products meets the FDA Indirect Food Additive requirements cited in 21 CFR 177.2910. All other component materials also meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182. | |||
| * Cage, core, end caps and capsule housing | ||||