Pharmaceutical products intended for injection are becoming more and more commonly found in lyophilized form and this trend appears to grow steadily, especially for anti-infectives, biotechnology derived products, and in-vitro diagnostics. This is because lyophilized products have a series of advantages: they are long-term storable - more than two years - and easy to stock, even at room temperature; at the same time the lyo product has a rapid reconstitution in contact with the appropriate solvent, preserving the original product features. Now Antares Vision has been awarded an important grant from the European Commission, within the EU Horizon 2020’s SME instrument framework, to develop a new technology for the inspection of lyophilized pharma products for injection (parenteralia) products: the Lyo-Check machine.
Pharmaceutical Market is Changing
The worldwide pharmaceutical market is generally driven by the necessity of a constant increase in product quality in order to ensure patient safety and product compliance, as well as an increase in production output, in order to reduce the overall costs of the pharmaceutical products making them available to a wider spectrum of users. Since the lyophilized form is set to become the most widely used in the production of high added-value preparations for injection, the increase in product quality and production output is a current top priority, that can be achieved only by the combination of different factors and improvement strategies, which are being taken into account in the development of the Lyo-Check machine. The quality-control inspection of products in lyophilized form poses peculiar challenges, thus creating the need for an innovative dedicated system which is totally different from the one so far applied to inspect parenteral products in liquid form, already developed by Antares Vision.