| 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 outlet74 mm (2.91 in.) with flange inlet/flange outlet94 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 °C1.7 bar (25 psid) at 80 °C345 mbar (5 psid) at 123 °C |
| 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. |
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