Application: Sterile Compounding, Pharmaceutical

Membrane Material: PES Sterilizing Grade (Hydrophilic, Low Protein Binding, High Flow Rate

Pore Size: Highly Asymmetric Dual Layer 0.65um / 0.2um

Suitable Solution: Aqueous & Alcohol-Based

Estimated Filtration Volume*: 30.0L – 100L

Effective Filtration Area: 2,550 cm²

Sterilization: Factory Sterilized by ETO

Inlet Connection: Luer Lock Female

Outlet Connection: Luer Lock Male

Hold-up / Retention Volume: 148 mL (Approx.)

Bacterial Retention: Retains Brevundimonas diminuta (≥10^7 CFU/cm²), consistent with ASTM F838-20

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