Catalent Pharma Solutions will launch its new ADVASEPT technology for the aseptic filling of injectable drugs at INTERPHEX, March 18 – 20, at the Javits Center in New York. According to the company, the new platform provides a glass-free, aseptically filled, primary container that reduces or eliminates many concerns associated with traditional glass vials, including the risk of injuries to treatment providers and patients, the potential for glass particulate contamination and accidental breakage in transit, and subsequent product wastage.
ADVASEPT vial production leverages Quality by Design manufacturing techniques designed to optimize the blow-fill-seal manufacturing process. According to the company, a stopper is inserted during the blow-fill-seal process to create a next generation,glass-free injectable solution, minimizing the risk of contamination by reducing particles, process steps, and human interaction. The ADVASEPT stoppered vial is currently available in 10mL, 50mL and 100 mL sizes, with pop-off or twist-off tops. The vials are manufactured at Catalent’s Woodstock, IL facility, and are customizable. Containers can be tailored to meet specific customer needs across biologics, pharmaceuticals, generics, and animal health.
“This new technology eliminates the risk of glass particulate contamination, significantly reduces the risk of breakages and minimizes container weight through the use of an ultrapure plastic design,” said Catalent’s Jonathan Arnold, vice president and general manager of Advanced Delivery Technologies. “Catalent also brings analytical expertise in areas such as biologic substance testing, extractables and leachables, and stability, and we have scientifically shown comparability of a monoclonal antibody between traditional glass and ADVASEPT vials.”