SKU: D25CS020LFLM-PH-ETO
PureFlo® D25 Disc Filter - Sterile Compounding (Aqueous)
Product Specifications
- Application: Sterile
Compounding, Pharmaceutical, Biological - Membrane Material: PES
Sterilizing Grade (Hydrophilic, Low Protein Binding, High Flow Rate) - Pore Size: Single
Layer 0.2μm - Suitable Solution: Aqueous & Alcohol Base
- Estimated
Filtration Volume*: 60 mL – 200 mL - Effective
Filtration Area: 4.6 cm² - Sterilization: Factory
Sterilized by
ETO - Inlet Connection: Luer Loc Female
- Outlet Connection: Luer Loc Male
- Hold-up
Volume: 1.27 mL (Approx.)
- Integrity Test / Bubble Point: ≥18 psi in 60% IPA/40% Water, ≥17.5 psi in 70% IPA/30% Water, & ≥50 psi in 100% DI Water at 22°C
- 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
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