Bioluz offers its customers filling services for small and medium series bags in terminal sterilization. We have the authorizations for human drugs, veterinary drugs or for medical devices.
Terminal sterilization in a PVC (polyvinyl chloride) or PP (polypropylene) bag is carried out by steam sterilization generally in a situation of “over-destruction” with sterilizing values greater than 15 (F0≥15). This technique requires a control of the bioburden before sterilization.
It applies to aqueous, non-heat-sensitive solutions: sterile distilled water (in accordance with the European Pharmacopoeia or the USP), any aqueous solution having heat-resistant active ingredients.
The steam is used as a heat transfer fluid and transfers its energy to the flexible bag and then to the water into the container. The water in the sterilized container will be the process sterilizing agent.
The definition of sterilization cycles should follow the guideline issued by the EMEA.