High Potent - API manufacturing facility located in Unit-1, Derabassi


  • 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


Filtration equipments


  • Centrifuges, sparkler filters


Supporting post production equipments


  • Vacuum tray dryers, Microniser, Multimill, Sifters, Blenders

  • Operating temperature range: - 15 0C to +130 0C












 





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