SP's Fill-Finish System Chosen by NIBRT to Deliver Advanced Training in Biopharmaceutical Production
July 20, 2021
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 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."
The SP i-Dositecno 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 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.
The National Institute for Bioprocessing Research and Training (NIBRT) is a global centre of excellence for training and research in biopharmaceutical manufacturing. NIBRT is located in a world class facility in Dublin, Ireland. This facility is purpose built to closely replicate a modern bioprocessing plant with state-of the art equipment and enables NIBRT to offer the highest quality training and research solutions. NIBRT's mission is to support the growth and development of all aspects of the biopharmaceutical manufacturing industry.
About Biopharma Group
Biopharma Group, with dedicated regional offices in the UK, France, Ireland and USA, specialises in complete aseptic liquid and lyo fill/finish processing lines, serving the sterile injectable, pharmaceutical, bio-tech, cosmetic, and ophthalmological markets, as distributor partners representing SP brands including SP i-Dositecno, SP Hull, SP VirTis and SP Genevac. Across the group's divisions, Biopharma teams are committed to providing clients with the highest possible standard of service, support and products, with a mission to meet the precise needs of customer projects appropriate to the size and stage of development by augmenting in-house expertise and working together to make each project a success. Biopharma Group continues to adapt and be flexible in its approach to offering the industries it serves, what they need, now and in the future.
For more information, visit: https://biopharma.co.uk/bps/contact-2/