Aseptic claims its ‘closed-vial’ technology offers significant advantages over its competitors, providing a better solution to the challenge posed by the aseptic filling of sterile injectable products.
NextPharma will still offer its own vial filling services from facilities in Braine-l'Alleud, Belgium and San Diego, USA but has also made Aseptic's technology available to its clients.
In doing so NextPharma has expanded its service offering and made the ‘closed-vial’ technology more readily available.
Bill Wedlake, CEO at NextPharma, said: “We are delighted to have reached this agreement with Aseptic Technologies which enables us to enhance further the service we provide for our customers enabling them to access this new technology through NextPharma.”
Aseptic’s filling system is built around its novel vial, which it claims is “the first ready-to-fill vial that behaves as an isolator”.
The vial is sealed and sterilised with gamma irradiation before it arrives for filling. Performing these tasks prior to arrival at the filling line removes the need for the washing, sterilisation and stoppering stages normally associated with similar operations. In addition, the vial is made from plastic, eliminating the risk that it will break.
Stoppers on the pre-sterilised vials are pierced with stainless steel needles, allowing for the filling to take place. Once filling has taken place the stopper automatically reseals itself. As an extra layer of security a laser is used on the stopper to ensure it has sealed.
Aseptic claims its system removes several of the complexities associated with isolator technology, a widely used aseptic filling system. Consequently the system is said to be cheaper and take up considerably less space.
Savings are said to be generated as the system needs fewer operators, stoppering is not required and the vials do not needed to be cleaned or sterilised.
The vial filling for NextPharma will occur at Aseptic’s facility near Brussels, Belgium. Aseptic believes that it has created a simpler way of complying with increasingly stringent good manufacturing practices (GMP).
Aseptic said: “The constant improvement of cGMP guidelines, in order to avoid any possible contamination of the aseptic process, does not necessarily imply an escalation in the complexity of the equipment for aseptic production and packaging. This is the realisation that led to the creation of Aseptic Technologies.”