The procedure starts by ensuring that the automatic vial washing, sterilizing, and dehydrogenating (Tunnel Systems) machines are cleaned and properly set up. Verification of the devices is properly operated within the designated Grade A/Class 100 Area, which maintains strict air quality standards. Loading the vials onto the conveyor system of the tunnel ensures proper spacing and alignment. After sterilization, the procedure ends with dehydrogenation to remove pyrogens, such as endotoxins, from the vials.
The dry powder formulation is prepared according to the established formulation and manufacturing instructions; the filling machine is properly cleaned, sterilized, and set up for operation. Followed by the positioning of the washed, fixed, and dehydrogenated vials on the filling line. Initiation of the filling process ensures accurate dry powder dosing into each vial.
The next step is followed with a sticker labelling machine in the Grade A/Class 100 Area, ensuring it is clean and calibrated and provided with the required labelling artwork and information for the product. Activating the device to apply the designated stickers or labels onto each vial, displaying essential information such as product name, dosage, batch number, and expiry date—verification of the accuracy of the labelling and ensuring proper adherence to regulatory requirements is done at the third level.
Setting up the automatic cartooning machine in the designated area is done by the end of the process—the labelled vials onto the conveyor system of the cartooning device are then placed. Activating the machine automatically collects the vials and puts them into the designated cartons or boxes. This ends up with storing the packaged dry powder injectables appropriately in controlled conditions, ready for distribution. Critical operations are continuously monitored throughout the procedure using online CCTV systems and touch-free equipment. The facility maintains EU-14 Grade HEPA filters with 99.999% efficiency and operates Water for Injection (WFI) systems.
