CPHI Frankfurt 2025: Gaining an Advantage with RTU Cartridges
Primary packaging requirements are evolving in line with development trends; however, flexible and easily integrated ready-to-use solutions are beneficial options, highlight Dr. Robert Lindner and Christoph Zauner from SCHOTT Pharma.
Primary packaging performs the critical task of protecting the valuable drug products inside from external contamination risks while also ensuring that product stability is maintained during transport and storage. Compared with more traditional, small-molecule drugs, biologics are highly sensitive and have special requirements, particularly when it comes to primary packaging, specifies Dr. Robert Lindner, Global Product Manager for Bulk and Sterile Cartridges at SCHOTT Pharma.
The trends related to primary packaging for these sensitive products are clear, notes Lindner who points out the need for glass with controlled hydrolytic resistance to enhance the chemical durability of the glass while also keeping the pH stable for the duration of the shelf-life. “A very crucial part when looking at ready-to-use (RTU) packaging is really the siliconization technology that is being used. So, in our RTU cartridges, we are using a baked-on process, and there’s a lot of recent data demonstrating that silicone migration is really low,” he adds.
Building upon Lindner’s points, Christoph Zauner, Head of Global Product Management for Polymer Solutions at SCHOTT Pharma, highlights how polymer cartridges are a newer option for biologics. Leveraging knowledge from previous syringes that have been made out of polymers — Cyclic Olefin Copolymer (COC) — it has been possible to develop polymer cartridges that feature an inert surface with extremely low levels of free silicone, he specifies.
As more companies are seeking larger volumes, there is a possibility that bottlenecks will become apparent, particularly during sterilization, shipping, and handling. This trend can be supported nicely by the RTU cartridges, Lindner specifies. Logistically-speaking, however, it is necessary to have deeper nests because the containers are larger, which could complicate things on the filling line as more space is required, he explains.
“The other part that can be a logistical challenge is the lower packaging density,” Lindner adds. “The containers are larger, you can fit less containers into one nest, therefore, you have less containers with larger volume. So, that slows down the speed of the production line, and also significantly decreases the amount of containers per pallet.”
However, the RTU solutions offered by SCHOTT Pharma provide numerous benefits for larger volume requirements, such as the fact that customers do not need to perform final sterilization and the siliconization has already been performed, Zauner asserts. Additionally, the company offers RTU products in either polymer or glass and all have been designed to be compatible with leading machine vendors, allowing for seamless integration, he reveals. “We consult with our customers on the best material of choice and to the specific needs to ensure success for their projects,” Zauner confirms.
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About the Speakers
Dr. Robert Lindner, is the Global Product Manager for bulk and sterile cartridges at SCHOTT Pharma. He covers the whole value chain from primary packaging design and production to sterile secondary packaging. He also works on bringing additional value to pharmaceutical companies through novel secondary packaging solutions, ensuring GMP Annex I compliance. He has multiple years of experience in primary packaging and fill-and-finish processes, as well as managing international R&D projects and global technology networks. Robert holds a PhD in Physical Chemistry from Mainz University.
Christoph Zauner, is the Head of Global Product Management for Polymer Solutions at SCHOTT Pharma. In this role, he leads efforts to drive innovation, oversee product management, and spearhead business growth initiatives for polymer-based pharmaceutical solutions, aligning them with market trends. His work is deeply informed by key market dynamics, which necessitate advanced and customizable drug delivery systems, as well as the growing emphasis on patient-centric solutions that prioritize safety, convenience, and sustainability. Christoph, a polymer engineer, held various positions, including Director of Packaging Engineering Innovation and Development for a global pharmaceutical company.
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