Safe, efficient terminal sterilization
GMP regulations generally require terminal sterilization of parenteral products after packaging. Getinge offers solutions for terminal sterilization.
GMP regulations stipulate terminal sterilization providing that the quality, safety or efficacy of the parenteral products is not affected. (These regulations don't include packaging, which can generally be designed to withstand the sterilization process.)
Meeting every challenge
Getinge has many year of experience designing sterilizers, loading systems and processes that enable safe and efficient terminal sterilization of all types of packaging – ampoules, syringes, cartridges, bags, BFS containers and more. Getinge is also equipped to meet the challenges of the latest, most complex and sophisticated drug delivery systems, and we place our worldwide Process Development Centers at your disposal.
As terminal sterilization is a batch process, there can be logistical challenges to move the product (often tons per day) from continuous filling to batch sterilization, and then to continuous inspection and secondary packaging. Working in partnership with Flexlink, Getinge also offers logistic solutions to optimize workflow and provide maximum productivity.