| Opticap XL 2 | Opticap XL 4 | Opticap XL 5 | Opticap XL 10 |
| Filtration Area, m2 | 0.09 | 0.19 | 0.35 | 0.69 |
| Materials of Construction |
| Filter membrane | Hydrophilic PVDF | Hydrophilic PVDF | Hydrophilic PVDF | Hydrophilic PVDF |
| Structural components | Polypropylene | Polypropylene | Polypropylene | Polypropylene |
| O-ring | Silicone | Silicone | Silicone | Silicone |
| Vent/Drain | 1/4 in. hose barb with double O-ring seal |
| Maximum Inlet Pressure, bar (psi) | 5.5 (80) @ 23 °C; 2.8 (40) @ 60 °C; 1.0 (15) @ 80 °C |
| Maximum Differential Pressure, bar (psid) | Forward: 3.4 (50) @ 25 °C. Reverse: 3.4 (50) @ 25 °C, intermittent |
| Integrity Tests |
| Bubble Point at 23 °C | ≥1930 mbar (28 psig) air with water |
| Diffusion | – | Air through a 23 °C water-wet membrane: |
| ≤4.5 mL/min @ 1.5 bar (22 psig) in water | ≤7.5 mL/min @ 1.5 bar (22 psig) in water | ≤15 mL/min @ 1.5 bar (22 psig) in water |
| Gravimetric Extractables |
| w/ Prefilter | – | – | – | ≤50 mg after autoclaving and 24-h soak in ASTM Type 1 reagent gradewater |
| w/o Prefilter | ≤10 mg after autoclaving and 24-h soak in water at controlled room temperature | ≤10 mg after autoclaving and 24-h soak in water at controlled room temperature | ≤15 mg after autoclaving and 24-h soak in water at controlled room temperature | ≤25 mg after autoclaving and 24-h soak in water at controlled room temperature |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≤500 mL |
| Bacterial Endotoxins | <0.5 EU/mL as determined by the LAL test |
| Sterilization |
| w/ Prefilter | 3 autoclave cycles of 60 min @ 121 °C; not in-line steam sterilizable |
| w/o Prefilter | 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable |
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. |
| Non-fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). |
| Indirect Food Additive | All component materials 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. |
