Single-Use Systems Between Compliance and Circularity: A Critical View under EU-GMP-Annex 1 and European Green Deal.

Abstract

The revision of EU-GMP-Annex 1 has accelerated the adoption of single-use systems (SUS) in aseptic pharmaceutical manufacturing by favoring closed, prequalified equipment that support contamination control while reducing cleaning effort, cross-contamination risk, and capital expenditure. The European Green Deal and circular economy initiatives increase pressure to reduce waste and improve end-of-life management of plastic-intensive technologies. Published life-cycle assessments indicate that SUS can lower water, energy, and cleaning chemical consumption compared with stainless-steel equipment but also contribute measurably to climate-change impact and resource depletion and generate complex plastic waste streams that are difficult to recycle at high quality. This commentary summarizes current evidence at the interface of sterility assurance, regulatory drivers, and environmental performance and argues that the use of SUS should move beyond a binary "single-use versus stainless steel" debate toward application-specific optimization and deliberate design for disassembly and material recovery.