High Potent – API Facility

• Approved cGMP facility, Class 100,000 cytotoxic suites
• Occupational exposure limit (OEL) < 0.3 μg/m³/ 8 h
• Suitable for handling Safebridge category – 3 products
• Containment through AHU, Pressure Zoning, Isolators and Personal Protective Equipment
• Isolators equipped with HEPA filters in supply & double HEPA filters at exhaust
• Isolators with negative pressure to avoid contamination and exposure
• Material flow through Pass boxes
• Accreditations from TGA Australia, WHO GMP, USFDA & EDQM

  Equipment and Infrastructure

• Reactors
• SS316: 1 x 1.5 KL, 2 x 0.25 KL, 1 x 1.0 KL
• MSGL: 2 x 0.25 KL
• GA : 1 x 20 L
• SS316 Isolator : 7
• Column chromatography