Durapore 0.45/0.22 µm Hydrophilic Multilayer Filters
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.
Specifications
| 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 | ||||
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