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The Medicine Maker / Issues / 2024 / Articles / Oct / Ready for Anything
Manufacture Contract Manufacturing Services Quality & Compliance Business Practice Supply Chain Technology & Manufacturing Facilities & Equipment Regulation & Standards Business & Trends Supply Chain

Ready for Anything

The Alliance for RTU has been founded to accelerate and improve manufacturing quality, consistency, and regulatory efficiency.

By Rob Coker 10/07/2024 1 min read

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SCHOTT Pharma, Gerresheimer, and Stevanato Group have formed a strategic alliance to promote the use of ready-to-use (RTU) vials and cartridges in everyday pharmaceutical manufacturing operations. The Alliance for RTU aims to enhance operational efficiency, reduce contamination risks, and improve product quality by sharing expertise and technical knowledge to support pharmaceutical companies, CMOs, and CDMOs. The initiative, which will form part of a joint showcase at CPhI in Milan, also aims to establish an open expert platform for industry standards.

Credit: AdobeStock.com

In a statement, SCHOTT Pharma CEO Andreas Reisse said: “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.”

According to the members of the alliance, RTU setups can reduce the risk of contamination because the containers are pre-sterilized and ready for immediate use. They also claim that RTU solutions can help maintain consistency in product quality and safety.

Stevanato Group CEO Franco Stevanato added: “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.”

In terms of sustainability and environmental protection, the alliance believes RTU technology can reduce waste and energy consumption by eliminating the need for in-house sterilization processes. Additionally, the accumulated expertise could improve compliance with regulatory standards, which can be a significant barrier in the adoption of new technologies. As each new system or process must comply with stringent guidelines from national and international medicines agencies, the extensive validation, testing, and documentation can be time-consuming and costly. Again, a degree of standardization in practices and frameworks could simplify the regulatory approval process, as well as streamline the adoption of new solutions.

Gerresheimer board member Lukas Burkhardt commented: "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.”

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About the Author(s)

Rob Coker

Following a Bachelor’s degree in English Literature and a Master’s in Creative Writing, I entered the world of publishing as a proofreader, working my way up to editor. The career so far has taken me to some amazing places, and I’m excited to see where I can go with Texere and The Medicine Maker.

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