20 Inch Single Layer Pharmaceutical Grade Filter Capsule (SPCXPGC)

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The SPCX Capsule Filter features a single-layer, positively charged Polyethersulfone (PES) membrane that provides reliable sterilizing-grade filtration and endotoxin removal. Available in pore sizes from 0.03 to 0.45 µm, SPCX filters are validated for absolute bacterial retention and offer high flow rates with minimal pressure drop. The electropositive membrane attracts and retains negatively charged biological contaminants, including endotoxins and viruses, making it ideal for pharmaceutical and biopharmaceutical applications.

Key Features:

• Validated 0.03–0.45 µm absolute-rated PES membrane
• Electropositive charge enhances removal of endotoxins and cell debris
• Delivers >2-log endotoxin reduction
• 100% integrity tested and USP-compliant
• High flow rates and long service life

Performance Parameters:

• Max Operating Temp: 110 °F at 30 psid (43 °C at 2.07 bard)
• Forward Differential Pressure: 80 psid at 68 °F (5.52 bard)
• Reverse Differential Pressure: 50 psid at 68 °F (3.45 bard)
• Recommended Changeout Pressure: 35 psid (2.41 bard)

Sterilization & Cleaning:

• Filtered Hot Water: 90 °C (194 °F), 30 min, multiple cycles, max 3 psid
• Autoclave: 250 °F (121 °C), 30 min, 25+ cycles
• Inline Steam (Cartridge Only): 275 °F (135 °C), 30 min, 25+ cycles
• Chemical Sanitization: Compatible with standard concentrations of hydrogen peroxide, peracetic acid, and sodium hypochlorite

Filtration Area (Nominal):

• 2" – 1.2 ft² (0.11 m²)
• 5" – 3.4 ft² (0.32 m²)
• 10" – 7.3 ft² (0.68 m²)
• 20" – 14.6 ft² (1.36 m²)
• 30" – 21.9 ft² (2.04 m²)
• 40" – 29.2 ft² (2.72 m²)

Diffusion Test Specifications (Water-Wetted):

Typical Applications:

• Water for Injection (WFI)
• Process Water
• Biologicals
• Endotoxin-sensitive formulations

Construction Materials:

• Filtration Media: Single-Layer Positively Charged PES Membrane
• Support Layers, Cage, Core, Housing: Polypropylene
• Sealing: Thermal Bonding
• Gasket/O-Ring Options (Cartridge Only): Buna, Viton® (FKM), EPDM, Silicone, FEP-Encapsulated Silicone or Viton®

Regulatory & Quality Compliance:

• Validated per ASTM F 838-15(ae1) with >7-log retention of:
 - Acholeplasma laidlawii (0.03 µm)
 - Brevundimonas diminuta (0.10 & 0.22 µm)
 - Serratia marcescens (0.45 µm)
• USP <643> TOC and <645> Conductivity Compliant
• USP Class VI Biological Reactivity Compliant
• Non-Fiber Releasing (21 CFR 210.3(b)(6), 211.72)
• FDA Compliant for Food Contact (21 CFR 174.5, 177.1500, etc.)

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