The commercial prefilled syringe line at Cook Pharmica can process up to 600 syringes per minute, 36,000 syringes per hour, or 70 million syringes per year. The automated, high-speed syringe line is fully enclosed in a barrier isolator to provide the highest level of aseptic processing available by removing the human element from the entire process. With the ability to operate in smaller batches or full-scale campaigning, the prefilled syringe line is capable of bridging clinical programs into commercial production.
The process starts in a separate tub-loading room where tubs are loaded onto a pass-through conveyor and sent into the isolator for automatic debagging. After the tub is removed from the bag, it passes through a tunnel utilizing E-beam technology for tub decontamination. When it exits the E-beam tunnel, robotic arms remove the lid and liner to prepare the syringes for denesting and filling.
The line is capable of time-pressure or peristaltic filling, with temperature-compensating recirculation capabilities for suspensions. Programmable, nondestructive fill-weight checks ensure fill accuracy real-time and in-process. After filling, the system is capable of handling TeflonÂ® or FluroTecÂ® stoppers. The prefilled syringe line can accommodate a range of syringe sizes, including 0.5 mL, 1 mL long, 1-mL to 3-mL standard, and 5-mL syringes.
Each tub is coded with UV-excitable ink, and tubs can be transferred up and over through a tub paternoster to an automated inspection and labeling cell. The tubs can also be decoupled from the inspection-labeling cell and be off-loaded in the filling cell for either terminal sterilization or manual inspection. If the syringes are to be outfitted with a safety device, there is an automated assembly line for both BD Preventis and Safety Syringe devices.
All filling lines in the parenteral facility feed into the secondary packaging operation, where clinical or commercial product is packaged and prepared for distribution. With all operations under one roof, the timeline of manufacturing and delivering distribution-ready product is shortened and simplified.