INSIGHTS ON LIQUID DOSE MANUFACTURING

LIQUID DOSE MANUFACTURING SOLUTIONS

  • Having the right balance of capacity and capabilities in all market conditions is the struggle that Contract Manufacturer Organizations face daily. Add to it the cost and complexity of maintaining a suitable parenteral manufacturing facility, the risks can be high. With constantly evolving parenteral market needs, having flexibility while achieving high utilization is key to long term success. To support these challenges, AST’s line of aseptic and syringe filling and closing machines provide adaptive fill-finish capabilities to ensure that any contract manufacturing organization has the right capabilities for any vial, syringe filling or cartridge application.

  • ASEPTiCell is integrated with isolator-barrier technologies to fully enclose and tightly control the aseptic environment for ideal conditions for processing sterile drug products. The system can be configured with a Restricted Access Barrier System (RABS) or an aseptic isolator to provide uninterrupted aseptic conditions during production. With isolator integrated systems, the ASEPTiCell is completely compatible with repeated in-situ bio-decontamination using hydrogen peroxide to further enhance the sterility assurance of the system.

  • A gloveless system that reduces risk for flexible vial, syringe, and cartridge filling.

  • Used 12.26 sq meter (131.91 sq ft) BOC IMA freeze dryer, model LyoMax12, 316L stainless steel product contact surfaces, wth (12) total, (11) usable shelves, 914mm x 1219MM x 15mm thick shelves, 145mm shelf spacing, top down stoppering, rated to -60 c min temperature, slotted doors with unloading system, 17 sq meter external condensor, 345 kg ice capacity, (3) 30 hp Mycom refrigeration compressors, (2) EH250 Edwards vacuum pumps, SIP/CIP capable, Allen Bradley controls, 480 volt, serial# FD2889, built 1996.

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