Aseptic Filling Solution Provides Sterility Assurance Advantage For Pharmaceutical Manufacturer

In 2016, Emergent BioSolutions revamped its site quality plan at the Winnipeg, Canada facility and decided to replace outdated conventional filling equipment, which could not meet future production needs or regulatory compliance. After extensive evaluation, the company selected Cytiva’s SA25 aseptic filling workcell due to its sterility assurance advantages and flexibility for multiple vial sizes and product types. A cross-functional team, including engineering, regulatory, and quality experts, conducted thorough due diligence, including comparative testing, FMEA, and strategic planning, to ensure the system would support the transition of licensed commercial products.

Emergent purchased the SA25 in October 2017, completing factory acceptance testing (FAT) by February 2018 and installation in April 2018. By July 2019, the system was filling approved commercial products. One key challenge was the transition to new primary packaging components, including nested containers, stoppers, and press-fit vial closures, which were assessed for equivalency to existing packaging to avoid disruptions. The SA25’s closed, robotic aseptic process minimized risk, reduced physical labor for operators, and required less physical interaction with the machine.

Key lessons learned included the importance of early involvement from supporting groups like quality assurance, regulatory affairs, and analytical development. This collaborative approach helped overcome obstacles and ensured that the SA25 system met Emergent’s goals of superior product quality, sterility assurance, and flexibility for both branded and contract-manufactured products.