Durapore® 0.45 µm Cartridge Filters
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Overview
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FAQ
| Question | Answer |
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| 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. |
| Are any of the prefilters compatable with ozone? | No. The Mykrolis corporation has ozone compatible filters. Please contact them for help with your specific application. They can be reached at 877-695-7654. |
Related Products & Applications
Product Families
Durapore® 0.45 µm Capsule FiltersAutoclavable, Gamma compatible or Presterilized bioburden reduction filters for process protection and prefiltration in single use applicationsLearn More >> |
OptiScale® Capsule Filters for Clarification and Prefiltration ApplicationsThese “drop-in” filter devices, with a variety of media options, create an effective platform for rapidly evaluating biopharmaceuticals.Learn More >> |
Durapore® 0.45 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.Learn More >> |
Related Products By: Application Facete
| Antibody Purification |
| Dialysis and Filtration |
Related Products By: Brand Facete
| Durapore® |
Categories
| Biopharmaceutical Manufacturing > Upstream Processing > Bioburden Reduction / Particulate Control > Membrane based > Durapore |
Description
Durapore® 0.45 µm hydrophilic filters are manufactured from polyvinylidene fluoride (PVDF) membrane with a cellulose ester (RW06) prefilter layer for greater throughput and polypropylene components for broad chemical compatibility. They also exist without prefilter layer.
Durapore® filters are 100% integrity tested during manufacturing to guarantee integrity.
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 marked with the product name and identifying characteristics.
Typical Applications
Durapore® 0.45 µm hydrophilic filters remove particles and microorganisms from aqueous liquid streams. These filters are ideally suited for large volume parenteral or ophthalmics manufacturing, where prefiltration is either unnecessary or already present at an earlier point in the process, or where protein binding must be minimized.
| OptiScale® and Millipak® Capsules | ||||
| OptiScale® 25 Capsules | OptiScale® 47 Capsules | Millipak® 100 | Millipak® 200 | |
| Nominal Dimensions | ||||
| Maximum 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 |
13 cm (5.1 in.) | 15.5 cm (6.1 in.) |
| Diameter: | 31 mm (1.21 in) | 69 mm (2.75 in.) | 7.6 cm (3.0 in.) | |
| Weight: | 0.19 oz (5.5 g) | 2.3 oz (67 g) | — | — |
| Filtration Area | 3.5 cm² | 17.7 cm² | 500 cm² (0.54 ft²) | 1000 cm² (1.08 ft²) |
| Materials of Construction | ||||
| Filter membrane: | Hydrophilic polyvinylidene fluoride (PVDF) | |||
| Structural components: | Polypropylene | Polycarbonate | ||
| Supports: | Polypropylene | Polycarbonate | ||
| Vent caps: | Polypropylene | Polyvinylidene fluoride (PVDF) | ||
| Internal seal rings: | Fluoroelastomers | — | ||
| 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 device. | ||
| Maximum Inlet Pressure | 4.1 bar (60 psig) at 25 °C | 5.5 bar (80 psig) at 25 °C | 5.2 bar (75 psig) at 25 °C | |
| Maximum Differential Pressure | ||||
| Forward: | 4.1 bar (60 psig) at 25 °C | 5.5 bar (80 psig) at 25 °C | 4.1 bar (60 psid) at 25 °C 1.7 bar (25 psid) at 80 °C 345 mbar (5 psid) at 123 °C |
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| Reverse: | 0 bar (0 psig) | 0.7 bar (10 psig) at 25 °C | 690 mbar (10 psid) at 25 °C | |
| Bubble Point at 23 °C | — | — | ≥ 1790 mbar (26 psig) air with water | |
| Gravimetric Extractables | — | — | After autoclaving and a 24-hour soak in ASTM Type 1 reagent grade water at controlled room temperature: | |
| ≤ 2.5 mg | ≤ 5.0 mg | |||
| Bacterial Endotoxin | Aqueous extraction contains | — | Aqueous extraction contains | |
| Oxidizable Substances | — | Meets the requirements of the USP Oxidizable Substance Test after a water flush of: | ||
| ≤ 100 mL | 200 mL | 200 mL | ||
| 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 a WFI water flush of 15 mL. | — | ||
| Sterilization | May be autoclaved for 1 cycle of 60 minutes at 123 °C | May be autoclaved for 3 cycles of 60 minutes at 126 °C | May be autoclaved for 3 cycles of 90 minutes at 123 °C. Capable of 45 kilogray (4.5 Megarad) gamma exposure (cannot be steam sterilized in-line). | |
| Good Manufacturing Practices | These products are manufactured in a Millipore facility which adheres to FDA Device 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 meet the requirements of USP <88> Reactivity Test for Class VI Plastics. This product is non-toxic per the current USP <88> Safety Test. | |||
| 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 components meet the FDA Indirect Food Additive requirements cited in 21 CFR 177 – 182. | |||
| Opticap® XL Capsules and Cartridge Filters | |||||
| Opticap® XL 2 | Opticap® XL 4 | Opticap® XL 5 | Opticap® XL 10 | Cartridge (per 10-inch element) | |
| Nominal Dimensions | |||||
| Maximum length: | 14.2 cm (5.6 in.) | 19.6 cm (7.7 in.) | 21.6 cm (8.5 in.) | 33.5 cm (13.2 in.) | — |
| Diameter: | 8.4 cm (3.3 in.) | 10.7 cm (4.2 in.) | 6.9 cm (2.7 in.) | ||
| Filtration Area | 0.09 m² (0.93 ft²) | 0.19 m² (2.09 ft²) | 0.35 m² (3.7 ft²) | 0.69 m² (7.4 ft²) | |
| Materials of Construction | |||||
| Filter membrane: | Hydrophilic PVDF | ||||
| Prefilter media: | Mixed esters of cellulose | ||||
| Film edge: | — | Polypropylene | |||
| Structural components: | Polypropylene | ||||
| Supports: | Polypropylene | ||||
| Vent O-rings: | Silicone | — | |||
| 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 |
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| Maximum Differential Pressure | |||||
| Forward: | 5.5 bar (80 psid) at 25 °C (with prefilter) 1.0 bar (15 psid) at 80 °C (with prefilter) 3.4 bar (50 psid) at 25 °C (without prefilter) |
5.5 bar (80 psid) at 25 °C 1.8 bar (25 psid) at 80 °C 345 mbar (5 psid) at 135 °C |
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| Reverse: | 3.4 bar (50 psid) at 25 °C, intermittent | 3.5 bar (50 psid) at 25 °C, intermittent | |||
| Bubble Point at 23 °C | ≥ 1930 mbar (28 psig) air with water | ||||
| Air Diffusion | Through a water wet membrane at ambient temperature at 1.5 bar (22 psi): | Through a water wet membrane at 23 °C at 1.5 bar (22 psi): | |||
| — | ≤ 4.5 cc/min | ≤ 7.5 cc/min | ≤ 15 cc/min | ||
| Gravimetric Extractables | After autoclaving and a 24-hour soak in ASTM Type 1 reagent grade water at controlled room temperature: | ||||
| With prefilter: | — | — | — | ≤ 50 mg | ≤ 45 mg |
| Without prefilter: | ≤ 10 mg | ≤ 15 mg | ≤ 25 mg | ≤ 20 mg | |
| Bacterial Endotoxin | Aqueous extraction contains < 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | ||||
| Oxidizable Substances | Meets the requirements of the USP Oxidizable Substance Test after a water flush of: | ||||
| 500 mL | 1000 mL | ||||
| Sterilization (with Prefilter) | |||||
| Autoclaved: | 3 cycles of 60 minutes at 121 °C. | 10 cycles of 60 minutes at 121 °C | |||
| Steam Sterilization: | Cannot be steam sterilized in-line. | 10 cycles of 30 minutes at 121 °C | |||
| Hot Water Sanitization: | — | 30 cycles of 30 minutes at 80 °C | |||
| Sterilization (without Prefilter) | |||||
| Autoclaved: | 3 cycles of 60 minutes at 126 °C | 30 cycles of 60 minutes at 126 °C | |||
| Steam Sterilization: | Cannot be steam sterilized in-line. | 30 cycles of 30 minutes at 135 °C | |||
| Hot Water Sanitization: | — | 30 cycles of 30 minutes at 80 °C | |||
| Total Organic Carbon (TOC)/Conductivity | Autoclaved filter effluent meets the WFI requirement of USP <643> , for Total Organic Carbon and USP <645> for Water Conductivity at 25 ºC after a WFI flush of 11.5 L | ||||
| 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 are non-toxic per the current USP <88> Safety Test. | ||||
| 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. | ||||
| European Pressure Equipment Directive | 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 Equipment Directive, this product does not bear the CE mark. | — | |||