JUNE 2021LIFE SCIENCES REVIEW 19Improving the Standard in Fill FinishBerkshire Sterile Manufacturing (BSM), a small-scale sterile drug manufacturer, was established in 2014 by three industry professionals with over 50 years of combined experience in fill-finish. Their mission was to utilize new technology in the industry to enhance the sterility assurance of parenteral for clinical and small-scale commercial production.Aiming to serve the industry better, BSM's team worked with several leading equipment suppliers to design their ultra-flexible and isolator-based filling line. This line was one of the first small-scale filling lines capable of filling syringes, cartridges, vials (either RTU or bulk), and lyophilized products. BSM started with a manual filling isolator in 2016, added a semi-automated filler in 2018, and has grown exponentially.BSM continues to redefine the quality standard in the small-batch filling. The company is currently installing a fully robotic, ultra-flexible, isolator-based filling line that will be operational by March 2022. This line is part of a $20M facility expansion to increase their capabilities and improve fill-finish standards.In designing this new line, BSM combined a standardized process module with advanced robotics. A double-headed filler provides exceptional flexibility and would be able to deliver increased fill speed to increase capacity. Robots were included to perform all the handling activities, such as loading and unloading the filler. They provide complete automation of the filling without the need for operator intervention. Despite designing the filling line to be completely automated, glove ports were still installed to serve as a precaution in unforeseen issues. As Shawn Kinney, the CEO of Berkshire Sterile Manufacturing, concludes, "Our philosophy is to offer quality, and innovation to customers, utilizing new technologies to improve the sterility assurance and quality of the products while ensuring regulatory compliance."This approach offers a lot of flexibility with a minimal footprint. The system could fill all the popular container types and sizes and multiple product types, including high viscosity fill. Adding robotics and automation to the system has also created more rapid and robust VHP decontamination cycles, improved line ergonomics, and sped up the changeover times between setups. Other technology such as 100% IPC (in process weight checks), decontamination of RTU tubs with pulsed light, the connection of the lyophilizer and lyophilization system to the isolator, and the ability to add lyophilizer in the future were all incorporated into this unique line. Many additional innovations will be employed in the future, and sterile filling companies are beginning a significant shift towards these types of technology.As pharmaceutical companies begin to embrace this type of innovation, advanced automation, robotics, remote monitoring, and other technologies will change how drug manufacturing is performed. Incorporating technology into pharmaceutical training, compliance, monitoring, and testing will enable the production of higher quality products. The future is bright for this industry, and BSM is one of the first companies to showcase this new technology transformation. Our philosophy is to offer quality, and innovation to customers, utilizing new technologies to improve the sterility assurance and quality of the products while ensuring regulatory compliance
< Page 9 | Page 11 >