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| Per 10-inch Cartridge | |
| Materials of Construction | |
| Filter medium | Polypropylene (PP) |
| Structural components | Polypropylene |
| O-rings | Silicone (SI) |
| Seal Material - Code F | Polyethylene (PE) |
| Seal Material - Code P | Silicone (SI) |
| Maximum Differential Pressure, bar (psid) | 4.8 bar (70 psid) @ 25 °C |
| Gravimetric Extractables | ≤10 mg after 24-h soak in water |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L |
| Bacterial Endotoxins | Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Sterilization | 10 autoclave cycles or SIP @ 126 °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. |
| 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):
D002 = 0.2 µm
D003 = 0.3 µm
D005 = 0.5 µm
D010 = 1.0 µm
D030 = 3.0 µm
