Mitigating Risks Associated With Single-Use Systems: Critical Considerations

By Justin Carbungco, Team Lead for Small Commercial Manufacturing (sCMO)

In recent years, single-use systems have become a popular choice for pharmaceutical manufacturers seeking to “right-size” operations and stay lean, from both an operational and economic standpoint. Teams procuring up to 2,000L of material frequently choose a single-use system based on the equipment’s list price, as well as the convenience offered by toss-and-replace components that streamline cleaning and validation protocols. Stainless steel systems, on the other hand, continue to play a pivotal role in the production of biologics that require large volumes and have lower operational costs with great flexibility in terms of production scale.

Issues such as capacity, scale-up, and flexibility dominate discussions around “single-use or stainless steel,” but there are many valid reasons why a manufacturer might choose one over the other (including energy usage, cleaning validation, cross-contamination risks, disposal of plastic waste, etc.) If you plan to utilize a single-use system for your product manufacturing, be sure to consider the following factors, all of which play an important role in determining your project’s total risk profile.