Sterilization processes for wide variety of drug delivery systems
GMP regulations require terminal sterilization of products after packaging as long as the quality, safety or efficacy of the product is not affected. These regulations do not include packaging, which can generally be designed to withstand the sterilization process. 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.
Getinge terminal sterilization and logistic systems, enable safe and efficient terminal sterilization of all types of packaging – ampoules, syringes, cartridges, bags, BFS containers and more. Through Getinge’s process development capabilities, we can support the latest, most complex and sophisticated drug delivery systems.