INSIGHTS ON SOLID DOSE MANUFACTURING

SOLID DOSE MANUFACTURING SOLUTIONS

  • AST’s line of table-top machines, GENiSYS® Lab, are ideal systems for drug product development and cGMP production applications. Each system is designed to automate the critical aseptic operations for vial, syringe and cartridge processing to reduce contamination risk and product variability. These table-top systems are engineered to have complete compatibility with cleanroom environments, including Laminar Air Flow Hoods, Bio-Safety Cabinets and aseptic isolators.

  • Handling highly potent active pharmaceutical ingredients calls for containment systems that protect operators while maintaining strict OEL thresholds below 0.1 μg/M3 throughout every transfer step.

  • We have defined work flows to assess and select solid forms in a cost and time efficient manner that meets the needs of each individual program.

  • Isolators with product protection as a housing for aseptic processes, e.g. filling, loading and unloading of freeze dryers.

  • Used 8 sq meter Rosenmund filter dryer, 304L stainless steel construction, rated 50 psi and full vacuum internal at 350 f, jacketed for 150 psi and full vacuum at 350 f, cored 3 wing agitator with rotary union driven by 40 hp motor drive, 460 volt, side discharge with plug valve, includes APOVAC vacuum recovery system, model APOVAC 3817, with Sulzer Burckhardt vacuum pump, condensor and receiver tank, hydraulic power pack, Filter certified by Paul Mueller Co, serial# 170084, national board# 25763, Rosenmund serial# RSD8-886-96, built 1996.