Comecer’s automatic aseptic filling line for IV bags is a high-speed turnkey solution that can process a variety of IV bag formats in both small and large batches. It uses isolation technology from start to finish to guarantee asepsis and containment. It provides complete separation between the process and the operator while reducing human intervention to a minimum. The filling line comes complete with in-line integrity testing.
The filling line can process bags from 50 ml to 1 liter bags without format part changes, at a rate of up to 2300 pieces per hour, with peristaltic or volumetric integration. It includes LAF isolation technology with a built-in VPHP decontamination system.
The operator loads the pre-sterilized, wrapped bags onto the rollers in the decontamination chamber. Hydrogen Peroxide Vapor (VHP) then decontaminates the outer surface of the bags. Once the operator closes the chamber doors, the bags are automatically transferred to the feeding chamber.
In the feeding chamber, the operator removes the outer wrapping and places the single bags on the conveyor belt. A camera guides the robots to pick up and fix the bags on the carousel.
The filling process starts with the cutting of the IV bag tubes using clean-cut technology and local exhaust ventilation (LEV). Next, a leak integrity test is performed with the overpressure method. Volumetric pumps fill the bags, while the weight is verified with 100% accuracy. Finally, the bag tubes are clean welded in a two-step process that enhances the reliability of the system.
Before the end of the process, the system prints variable batch data on the bags, and inspects printed data and tests weld quality.
Solutions using Isolation technology have a physical barrier system that provide a specific level of containment, while also offering, for aseptic and combined processes, a significant risk reduction of bio-contamination and continuous, Grade A isolation of its interior from the external environment.