Catalent launches Advasept technology
For the aseptic filling of injectable drugs
Catalent Pharma Solutions will launch its Advasept technology for the aseptic filling of injectable drugs at next week's Interphex exhibition, which takes place from 18–20 March at the Javits Center, New York City, NY, US.
Catalent says 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, the potential for glass particulate contamination and accidental breakage in transit and subsequent product wastage.
Advasept vial production leverages Quality by Design manufacturing techniques that have optimised the blow-fill-seal manufacturing process. The company says a stopper is inserted during the blow-fill-seal process to create a glass-free injectable solution, minimising 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 caps. It is manufactured at Catalent’s Woodstock, IL facility.
'This new technology eliminates the risk of glass particulate contamination, significantly reduces the risk of breakages and minimises 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.'
