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| Per 10-inch Cartridge | ||
| Filtration Area | ||
| Single Layer | 0.8 m² | |
| Double Layer | 0.69 m² | |
| Materials of Construction | ||
| Chemistry | Mixed Cellulose Esters (MCE) | |
| Support Material | Polyester | |
| Device Material | Polypropylene | |
| Seal Material | Silicone (SI) | |
| Maximum Differential Pressure, bar (psid) | 3.5 bar (50 psid) @ 25 °C | |
| Gravimetric Extractables | ||
| Standard Milligard® Media | The extractables level was equal to or less than 50 mg per 10-inch cartridge after 24 hours in water at controlled room temperature. | |
| Low Protein Binding Milligard® Media, 0.2 µm | The extractables level was equal to or less than 100 mg per 10-inch cartridge after a 5 L flush and 24 hours in water at controlled room temperature. | |
| Low Protein Binding Milligard® Media, 0.5 µm | The extractables level was equal to or less than 100 mg per 10-inch cartridge after a 5 L flush and 24 hours in water at controlled room temperature. | |
| Low Protein Binding Milligard® Media, 1.2 µm | The extractables level was equal to or less than 250 mg per 10-inch cartridge after a 5 L flush and 24 hours in water at controlled room temperature. | |
| Low Protein Binding Milligard® Media, 1.2/0.5 µm | The extractables level was equal to or less than 200 mg per 10-inch cartridge after a 5 L flush and 24 hours in water at controlled room temperature. | |
| Low Protein Binding Milligard® Media, 1.2/0.5 µm | The extractables level was equal to or less than 350 mg per 10-inch cartridge after a 5 L flush and 24 hours in water at controlled room temperature. | |
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L | |
| Sterilization | 10 autoclave cycles or SIP @ 121 °C for 30 min | |
| 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 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. | |
Cartridge Legends Refer to Pore Size (nominal):
Milligard Media
CW03 = 0.2 µm
CW06 = 0.5 µm
CW19 = 1.2 µm
CWSC = 1.2/0.5 µm
CWSS = 0.5/0.2 µm
Milligard LPB Media
CWL3 = 0.2 µm
CWL6 = 0.5 µm
CWL9 = 1.2 µm
CWLC = 1.2/0.5 µm
CWLS = 0.5/0.2 µm
