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Injectable drugs in flexible bags: A new process, from pre-sterilized bags to the aseptic filling.
Technoflex-Bioluz Company has been producing flexible bags for the Pharma industry for nearly 25 years. As far as is concerned, the aim was to manufacture a non-pyrogen and pre-sterilized IV bag specially designed for an aseptic filling line. Due to the high temperature of plastic extrusion process and a well-contained environmental control, free of gram negative bacteria, the endotoxine level is kept under control. The bags are closed and then e-beamed with the appropriate level of beta radiation.
A brand new, state-of-the-art, and fully automated aseptic filling line has been set up. The filling of drugs is done aseptically in A/B class environment, with a fully automated process from the loading of pre-sterilized bags and stoppers up to the overwrapping. The new developed technology offers a greater control over safety issues and avoids the risks of product contamination, providing a higher capacity of production (Industrial scale capacities).
Bioluz and Technoflex’s philosophy is to offer to the pharmaceutical industry the latest technological advancements for the IV bag market: aseptic filling of injectable drugs in pre-sterilized bags and assistance support when transferring the process from vials to flexible bags.