SCHOTT Pharma, Gerresheimer and Stevanato Group have entered into a strategic industry allilance.
The 'Alliance for RTU' aims to support CMO and CDMOs in adopting RTU vials and cartridges instead of standard bulk packaging.
The collaboration aims to reduce the risks associated with traditional fill/finish processes, while also bolstering the flexibility and efficiency of day-to-day contract manufacturing of injectables.
RTU protocols, according to the trio, will also lower waste and streamline the manufacturing process — enhancing productivity while reducing the risk of contamination and ensuring EU GMP Annex 1 compliance.
Pharmaceutical companies will also see a minimisation in the release of contaminating glass particles into formulations, which significantly enhances patient safety.
Open expert platform for RTU industry standard
The market is also seeing enhanced investments into advanced aseptic filling technologies.
This is because of the increasing demand for injectables, as well as the pressure of global regulations.
The Alliance for RTU scheme will offer an expert platform where industry manufacturers can discover the key benefits of RTU processes, allowing them to determine if they are right for their business.
CEO of SCHOTT Pharma, Andreas Reisse, commented: “The shift towards ready-to-use vials and cartridges reflects a collective industry move to advance quality and efficiency in aseptic filling processes and this alliance shows readiness by expanding capacity and thereby supporting this market trend,”
“Ready-to-use solutions can reduce complexities and better meet the stringent requirements of modern pharmaceutical production.”
“RTU vials and cartridges represent a significant advancement in product quality, offering enhanced reliability and efficiency in pharmaceutical processes. This alliance allows us to highlight further how RTU solutions elevate standards across the industry, ensuring safer and more effective delivery of medications to patients worldwide," said Franco Stevanato, CEO at Stevanato Group.
A member of the Management Board at Gerresheimer, stated: "As an industry, we are fully prepared for the transition to RTU vials and cartridges,”
“With recent advancements, RTU processing is now a mature technology which will improve our customers operations in terms of efficiency, cost and time to market.”