2024-10-17

Q: What challenges did 3P Innovation face in designing the RFF Cell for handling difficult-to-manage powders?

Tom Bailey: Our engineers encountered several challenges in the development of the RFF (Robotic Fill-Finish) Cell to manage difficult-to-handle powders. Many new drug entities in powder form exhibit poor flow characteristics, making them prone to clogging and inconsistent dosing during the filling process. Additionally, these powders are often sensitive to static electricity, which can cause them to become charged and adhere to surfaces, further complicating handling and accurate filling. Over a decade of research and development, 3P Innovation developed advanced Fill-to-Weight technology to address these issues. This technology ensures precise dosing by weighing each fill, compensating for the poor flow properties of the powders. Furthermore, they implemented static control techniques to neutralize the static charge on the powders, preventing them from clumping or sticking to equipment. These innovations collectively ensure that the powders are handled and filled accurately and consistently, maintaining the integrity and efficacy of the drug products.

Q: Discuss the role of robotics in improving the efficiency and reliability of the filling process and what are the key features of the RFF Cell that differentiate it from traditional fill-finish equipment?

Tom Bailey: Robotics plays a crucial role in enhancing the efficiency and reliability of the filling process within the RFF Cell.  The RFF robotics provides format flexibility and rapid changeover from vials to syringes or cartridges. The system takes advantage of drug containers in RTU (ready to use) format and allows changeovers in less than an hour.

The 3P system removes individual containers from the RTU nest using advanced robotics. This provides significant advantages over traditional lines and filling directly into the nest. It allows 100% inspection of each container. It includes net weight of the filled drug, vision inspection of the stopper position and inspection of the crimp cap. Any faulty products are removed from the process and not returned to the tub. These features collectively improve the reliability and efficiency of the filling process.

Q: What quality control measures are integrated into the RFF Cell to ensure product integrity and compliance with regulatory standards?

Tom Bailey: The robot cell has been designed in strict accordance with Annex 1 and with the advice of former MHRA experts. The robotic system includes the latest contamination control measures and a VPHP decontamination system with Catalytic conversion of the Hydrogen peroxide decontamination vapour.

The fill finish sits inside a state-of-the-art isolator system with integrated air handling and continuous environmental monitoring. These measures ensure that the RFF Cell operates in compliance with regulatory standards, safeguarding the integrity and safety of the drug products.

Q: How does the Vacuum Drum Filler contribute to improving efficiency in drug packaging?

Tom Bailey: The Vacuum Drum Filler improves efficiency in drug packaging by providing a reliable and precise method for filling powders into various containers. This system uses vacuum technology to ensure accurate dosing and minimise product loss during the filling process. By reducing manual handling and enhancing automation, the Vacuum Drum Filler increases throughput and reduces the risk of contamination. Its efficient design enables quick changeovers between different products, further improving production efficiency and flexibility.

Q: How does 3P Innovation support customers in establishing production-representative processes using the Discover range offerings?

Tom Bailey: The design philosophy behind the Discover range is to create systems that are production ready and scalable. Each process has been carefully designed to be robust, ensuring it can operate 24/7 in a production environment.