SP Scientific Products (SP) announces a collaboration with the National Institute for Bioprocessing Research and Training (NIBRT) in Dublin, Ireland, to install a modular multi-container filling line and isolation system to further enhance training offerings in aseptic biopharmaceutical fill-finish operations.
NIBRT selected the SP i-Dositecno robotic filling and stoppering system for pre-sterilized vials, syringes, and cartridges in a nested format, as well as a vial capper, for its global center of excellence for training and research in bioprocessing. The system will be installed by Spring 2022.
With the biopharmaceutical industry’s increasing move towards drugs aimed at smaller patient groups, such as highly targeted oncology therapeutics, personalized medicines, and orphan drugs, there is a growing need for advanced technology and robust aseptic manufacturing that is both more efficient and cost-effective. To educate the highest-caliber biopharmaceutical workforce of the future on the principles and techniques required for aseptic fill-finish processes, NIBRT delivers hands-on training using an environment that replicates the most advanced industrial bioprocessing facility. The institute therefore required modernized, state-of-the-art sterile fill-finish equipment for aseptic filling training.
“We are proud to be recognized and selected by such a respected institute to contribute to the superior training that NIBRT offers in its realistic GMP simulated, operational manufacturing environment,” said Brian Larkin, President & CEO, SP Scientific Products (SP) Industries. “Our SP i-Dositecno aseptic filling line reflects the very latest industry standards for automated filling and checking of containers in nested tubs, fulfilling NIBRT’s need to train on the most advanced manufacturing equipment.”
SP Scientific Products (SP) i-Dositecno’s aseptic fill-finish system is modular, highly flexible, and easy to install. The NIBRT installation will include an integrated particle counter monitoring system for environmental monitoring (EM) and automated container rejection capability. An ESCO isolator on the filling unit and an open restricted access barrier system (RABS) for debagging/de-lidding, de-nesting and capping stations will reduce operating cost in lieu of an isolator. This will provide the barrier to the operation and simulate cleanroom conditions as closely as possible. Using SP i-Dositecno automation requires fewer personnel to handle the process, so ensuring less human manipulation, intervention, and elimination of human error.
“We are looking forward to developing a new and optimized fill-finish training curriculum involving our SP Scientific Products (SP) i-Dositecno equipment, which will bolster and enhance the training experience we currently offer. Thanks to SP’s technologically advanced filling solution and isolator technology, NIBRT’s training offering will be more reflective of processes used by our valued clients,” said Aoife Barron, Training Team Lead and Fill-Finish SME, NIBRT. “As well as securing the best equipment for aseptic manufacturing, SP’s ability to understand our requirements, provide technical expertise in responding to our inquiries, and to rapidly quote, build and install a modular fill-finish solution was also a major factor in our purchasing decision. The system can also be reconfigured easily to grow with our needs, and we plan to add the capping station at a later stage.”
NIBRT will be using SP i-Dositecno aseptic fill-finish equipment in its hands-on bioprocessing training courses from Spring 2022.