Single-Use Technologies and Processing Equipment

Single-Use Technologies for Bioprocessing and Manufacturing of Biologics

Single-use technologies (SUT) are increasingly being used at all stages of the biopharmaceutical manufacturing process and their adoption has greatly accelerated in recent years. These disposable polymer-based components may include:

• Filters
• Process containers (bags)
• Tubing
• Connectors
• Gaskets
• Valves

Controlling Extractables and Leachables for SUT

All product contact surfaces have the potential to release extractable material into a process, so extractables and leachables must be considered to ensure components are unadulterated. Smithers uniquely qualifies to support clients in this challenge, with world-class polymer knowledge and specialist expertise in both standard and customized protocols to assess the impact of extractables and leachables on the use of these products.

Understanding SUT Materials and Performance

Single-use systems can introduce a range of materials into a biopharmaceutical manufacturing process, making material selection, compatibility, and extractables and leachables assessment important considerations during development. Smithers can help evaluate individual components and complete systems, considering factors such as the process fluid, contact time, temperature, and intended use. Testing strategies can be tailored to the specific materials and application, including controlled extraction studies and leachables assessments based on relevant industry guidance and standards.

Chemical analysis can be combined with physical and functional testing to evaluate how single-use components perform throughout their intended lifecycle. Smithers supports studies ranging from material characterization and component compatibility to packaging, aging, transit, connection performance, and failure investigation. This integrated approach can help manufacturers understand both the chemical profile of their single-use systems and how components perform within the manufacturing process.