| Per 10-inch Cartridge Filter |
| Materials of Construction |
| Filter Media | Borosilicate Glass Fiber (BGF) |
| Supports | Polypropylene |
| Structural Components | Polypropylene |
| O-rings | Silicone (SI) |
| Filtration Area | 0.46 m² |
| Maximum Differential Pressure, bar (psid) | 3.5 bar (50 psid) @ 25 °C |
| Bacterial Endotoxins | Aqueous extraction contains ≤1.0 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Gravimetric Extractables | The extractables level was equal to or less than 250 mg per 10-inch cartridge after 24 hours in water at controlled room temperature. |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L |
| 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. |
| Sterilization | 10 autoclave cycles or SIP @ 121 °C for 30 min |
| Sanitization | 30 min with hot water @ 80 °C |
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. |
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. |
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