How many do we need? How much is good enough? What kind of packaging would be needed?
Perfection made for people
At CPhI 2018 in Madrid, SCHOTT presented its next generation of vials. Senior Global Product Manager Florence Buscke explains why this new concept is the next step for pharmaceutical vials.
Why do you speak about a next generation?
With the next generation of vials SCHOTT is providing a new concept for pharmaceutical vials without the need of re-registration. It combines a number of features leading to unmatched drug stability without inner coating, even for so-called low-fill applications and efficient and cost-competitive fill & finish at our customer. It is summarizing our outlook and know-how as a result of longstanding expertise and co-innovation with our customers, described in six key features and combined in a modular product offer.
Talking about key features: What are the key benefits?
One of the key benefits is that for this new vial there is no need for re-registration because we use an improved Type I FIOLAX® borosilicate glass named FIOLAX® CHR (controlled hydrolytic resistance) by its hydrolytic custom specification. Pharma companies can replace conventional tubular Type-I glass vials for already marketed drugs with the next generation of vials without costly and timely re-registration. This borosilicate glass comes with a highly reduced and certified level of alkalinity release of the inner surface. Additionally the vials possess an unmatched drug stability because of our tighter controlled converting process enabling a superior extractables & leachables profile.
What about the fill & finish aspect you mentioned?
An efficient, fast and cost competitive fill & finish allows for an improved Total Cost of Ownership. This is achieved by combining process optimizations and improved dimensions within the existing standards for a flawless quality vial leading to an increased strength. A post process of the outer surface ensures sustainability of those properties thru the entire processing and further enables a low-friction surface, which eliminates any sticking or climbing effect on the lines.
Overall, we are incorporating the whole journey from the tube to our conversion process to the filling process in this concept. The complete product offering will be based on a modular approach depending on the customer’s needs.
What are the typical applications?
The superior chemical resistance and extractables and leachables (E&L) profile make the vials highly suitable for biologic drugs in the pipeline targeting Monoclonal Antibodies, Recombinant Proteins and Vaccines and their respective low filling volumes combined with challenging buffers. The latter refers to the vial being filled with a significantly smaller amount of the drug than the nominal volume of the container. Consequently, the ratio of the wetted surface to the volume is increased, which leads to a proportionally increased concentration of leached elements. This is particularly critical for sensitive formulations. Thanks to their high chemical resistance especially in the bottom area SCHOTT’s next generation vials show a low concentration of leached “glass” elements even for low fill volumes.