What are the trade-offs of single-use bioprocess equipment compared with stainless steel?

Why

In a stainless facility, every vessel must be cleaned and steamed between batches, which needs validated cleaning, water for injection and time. Single-use systems arrive sterile and are discarded, so changeover is quick and carryover between products is far less of a concern. That suits multiproduct clinical facilities and small batches.

The main technical trade-off is chemistry. Plastics release compounds. Extractables are chemicals released under exaggerated laboratory conditions, and leachables are those that actually migrate into the product under normal use.

A 2026 review on extractables and leachables describes bDtBPP, a degradation product of an antioxidant in polyethylene films, as inhibiting cell growth and cutting yields, with cytotoxicity at sub-ppm levels. So a new bag film can affect both patient safety and process performance. Assessments use supplier extractables data, then risk-based leachables studies at the steps closest to the final product.

USP now has a chapter, 665, for plastic components used in manufacturing. Other trade-offs include ongoing consumable cost, dependence on a few suppliers, which was exposed during the pandemic, lot-to-lot film variation, leaks from handling, and practical maximum vessel sizes. Many plants are hybrids, with single-use upstream and stainless at large scale.