Durapore® 0.1 µm and 0.22 µm Capsule Filters
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| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore |
Choosing the right membrane filter is critical to the success of your process. A trusted name in the industry Durapore® hydrophilic polyvinylidene fluoride (PVDF) membranes provide high throughput and superior robustness. They are low protein binding and non-fiber releasing with broad chemical compatibility and low extractables.
Durapore® 0.1 μm and 0.22 μm filters protect processes from microbial contamination and are used for applications requiring the highest degree of sterility assurance. Durapore® 0.1 μm filters can be used for filtration of cell culture media and feeds. Durapore® 0.22 μm filters are suitable for all liquid sterile filtration applications.
Capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings. They are available in a range of sizes, enabling easy scale-up and offered with multiple membrane options, in autoclavable, sterile and gamma-compatible formats.
Multiple Formats Available
Opticap® XL capsule filters are available in a wide range of media, surface areas, pore sizes, and inlet/outlet connections to meet your application needs.
Opticap® XLT capsule filters with T-line connections can accommodate series or parallel filtration to match your application needs. These filters are available in a range of media, surface areas, pore sizes. A specially designed stand enables quick and easy integration of the Opticap® XLT capsules into your existing process.
Regulatory Compliance
Our membrane filters 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 unit is integrity tested during manufacturing and is supported by a documentation package for compliance with regulatory requirements.
The Emprove® Program. Your fast track through regulatory challenges.
The Emprove® Program, complements our product portfolio, and provides three types of dossiers to support different stages of development and manufacturing operations such as qualification, risk assessment, and process optimization. The dossiers consolidate comprehensive product-specific testing data, quality statements and regulatory information in a readily available format to simplify your compliance needs.
Opticap® XL and XLT Autoclavable Capsule Filter Specifications
| Opticap® XL 2 Filters | Opticap® XL 4 Filters | Opticap® XL 5 Filters | Opticap® XL 10 Filters | Opticap® XLT 10 Filters | Opticap® XLT 20 Filters | Opticap® XLT 30 Filters | |
| 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.) | 38.1 cm (15.0 in.) | 62.5 cm (24.6 in.) | 87.1 cm (34.3 in.) |
| Body diameter | 8.4 cm (3.3 in.) | 8.4 cm (3.3 in.) | 10.7 cm (4.2 in.) | 10.7 cm (4.2 in.) | _ | _ | _ |
| Fitting to Fitting | |||||||
| Sanitary flange to sanitary flange: | _ | _ | _ | 15.2 cm (6.0 in.) | 15.2 cm (6.0 in.) | 15.2 cm (6.0 in.) | |
| Sanitary flange to hose barb: | _ | _ | _ | 17.5 cm (6.9 in.) | 17.5 cm (6.9 in.) | 17.5 cm (6.9 in.) | |
| Hose barb to hose barb: | _ | _ | _ | 19.8 cm (7.8 in.) | 19.8 cm (7.8 in.) | 19.8 cm (7.8 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) | 0.69 m2 (7.4 ft2) | 1.4 m2 (14.8 ft2) | 2.1 m2 (22.2 ft2) |
| Materials of Construction | |||||||
| Filter membrane: | Hydrophilic PVDF | ||||||
| Film edge: | Polypropylene | ||||||
| Supports: | Polypropylene | ||||||
| Structural components*: | Polypropylene | ||||||
| Vent O-ring: | Silicone | ||||||
| Vent/Drain | 1/4 in. hose barb with double O-ring seal: connects to 1/8 in. tubing | _ | _ | _ | |||
| 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, 1.0 bar (15 psid) at 80 °C | 5.5 bar (80 psid) at 25 °C, 1.7 bar (25 psid) at 80 °C | |||||
| Reverse: | 3.4 bar (50 psid) at 25 °C, intermittent | 3.4 bar (50 psid) at 25 °C | |||||
| Bubble Point at 23° C | |||||||
| 0.1 μm: | ≥ 4830 mbar (70.0 psig) air with water | ||||||
| 0.22 μm: | ≥ 3450 mbar (50.0 psig) air with water | ||||||
| Air Diffusion | Through a water wet membrane at ambient temperature: | ||||||
| 0.1 μm at 3.9 bar (56 psig): | — | ≤ 7.5 cc/min | ≤ 10.0 cc/min | ≤ 20.0 cc/min | ≤ 20.0 cc/min | ≤ 40.0 cc/min | ≤ 60.0 cc/min |
| 0.22 μm of 2.8 bar (40 psig): | ≤ 5.5 cc/min | ≤ 6.6 cc/min | ≤ 13.3 cc/min | ≤ 13.3 cc/min | ≤ 26.6cc/min | ≤ 39.9 cc/min | |
| NVR Gravimetric Extractables | After autoclaving and a 24 hour soak in ASTM® Type 1 reagent grade water at controlled room temperature: | ||||||
| ≤ 10 mg | ≤ 10 mg | ≤ 15 mg | ≤ 25 mg | ≤ 25 mg | ≤ 50 mg | ≤ 75 mg | |
| Oxidizable Substances | Meets the requirements of the USP Oxidizable Substances Test after a water flush of: | ||||||
| 500 mL | 500 mL | 500 mL | 1000 mL | 1000 mL | 2000 mL | 3000 mL | |
| Bacterial Endotoxins | Aqueous extraction contains | ||||||
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM® methodology. | ||||||
| Sterilization | May be autoclaved for 3 cycles of 60 minutes at 126 °C. (Cannot be steam sterilized in-line.) | ||||||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to 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 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 177-182. | ||||||
| *Cage, core, end caps, and capsule housing | |||||||
Opticap® XL and XLT Sterile and Gamma-Compatible Capsule Filter Specifications
| Opticap® XL 4 Filters | Opticap® XL 10 Filters | Opticap® XLT 10 Filters | Opticap® XLT 20 Filters | Opticap® XLT 30 Filters | |
| Nominal Dimensions | |||||
| Maximum length: | 19.6 cm (7.7 in.) | 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 | 8.4 cm (3.3 in.) | 10.7 cm (4.2 in.) | _ | _ | _ |
| Fitting to Fitting | |||||
| Sanitary flange to sanitary flange: | _ | 15.2 cm (6.0 in.) | 15.2 cm (6.0 in.) | 15.2 cm (6.0 in.) | |
| Sanitary flange to hose barb: | _ | 17.5 cm (6.9 in.) | 17.5 cm (6.9 in.) | 17.5 cm (6.9 in.) | |
| Hose barb to hose barb: | _ | 19.8 cm (7.8 in.) | 19.8 cm (7.8 in.) | 19.8 cm (7.8 in.) | |
| Filtration area | |||||
| 0.18 m² (1.9 ft²) | 0.73 m² (7.8 ft²) | 0.73 m² (7.8 ft²) | 1.45 m² (15.6 ft²) | 2.17 m² (23.4 ft²) | |
| Materials of Construction | |||||
| Filter membrane: | Hydrophilic PVDF | ||||
| Film edge: | Polyethylene | ||||
| Supports: | Polyester/polyethylene | ||||
| Structural components*: | Gamma-stable polypropylene | ||||
| Vent O-ring: | Lead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone | ||||
| Vent/Drain | 1/4 in. hose barb with double O-ring seal: connects to 1/8 in. tubing | _ | _ | _ | |
| 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 1.0 bar (15 psid) at 80 °C |
5.5 bar (80 psid) at 25 °C 1.7 bar (25 psid) at 80 °C |
|||
| Reverse: | 3.5 bar (50 psid) at 25 °C | 3.5 bar (50 psid) at 25 °C | |||
| Bubble Point at 23° C | |||||
| 0.1 μm: | ≥ 4830 mbar (70.0 psig) air with water | ||||
| 0.22 μm: | ≥ 3450 mbar (50.0 psig) air with water | ||||
| Air Diffusion | Through a water wet membrane at ambient temperature: | ||||
| 0.1 μm at 3.9 bar (56 psig): | ≤ 5.7 cc/min | ≤ 21.1 cc/min | ≤ 21.1 cc/min | ≤ 42.2 cc/min | ≤ 63.3 cc/min |
| 0.22 μm of 2.8 bar (40 psig): | ≤ 4.6 cc/min | ≤ 14.0 cc/min | ≤ 14.0 cc/min | ≤ 28.0 cc/min | ≤ 42.0 cc/min |
| Oxidizable Substances | Meets the requirements of the USP Oxidizable Substances Test after a water flush of: | ||||
| 1000 mL | 1000 mL | 1000 mL | 2000 mL | 3000 mL | |
| Bacterial Endotoxins | Aqueous extraction contains | Aqueous extraction contains | |||
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM® methodology. | ||||
| Sterilization | |||||
| 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 | May be autoclaved for 3 cycles of 60 minutes at 123 °C. (Cannot be steam sterilized in-line.) | ||||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to 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 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 177-182. | ||||
| *Cage, core, end caps, and capsule housing | |||||