| 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 °C2.8 bar (40 psi) at 60 °C1.0 bar (15 psi) at 80 °C |
| 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 °C1.8 bar (25 psid) at 80 °C345 mbar (5 psid) at 135 °C |
| 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. | — |
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