• Application: Sterile Compounding, Pharmaceutical, Biological
• Membrane Material: PTFE Sterilizing Grade (Hydrophobic, Chemically Inert, High Temperature Resistance)
• Pore Size: Dual Layer 0.45μm / 0.2μm
• Suitable Solution: Oil & Alcohol Base
• Estimated Filtration Volume*: 4.2L – 16.8L (50% less for Oils)
• Effective Filtration Area: 260 cm²
• Sterilization: Factory Sterilized by ETO
• Inlet Connection: Luer Lock Female
• Outlet Connection: Luer Lock Male
• Hold-up / Retention Volume: 8.6 mL (Approx.)

• Integrity Test / Bubble Point: ≥18 psi in 60% IPA/40% Water, & ≥17.5 psi in 70% IPA/30% Water
• Bacterial Retention: Retains Brevundimonas diminuta (≥10^7 CFU/cm²)
• Sterilization: ETO, complies with ISO 10993-7:2008, ANSI/AAMI/ISO 11135, SAL of 10^-6
• USP Compliance: Compliant with USP <797>
• Material Compliance: 21CFR Part 177, USP Class VI
• Endotoxins: <0.25 EU/ml (LAL Test)
• Usage: Safe for human and veterinarian use
• cGMP Compliance: CFR part 210 & 211, 21 CFR part 600, 21 CFR part 680
• Animal Components: Free from animal-derived materials, TSE/BSE free