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

Area of Science:

• Pharmaceutical Manufacturing
• Environmental Science
• Regulatory Compliance

Background:

• EU-GMP Annex 1 revision promotes single-use systems (SUS) for aseptic manufacturing, enhancing contamination control and reducing costs.
• Growing pressure from European Green Deal and circular economy initiatives necessitates better end-of-life management for plastic-intensive SUS.
• Life-cycle assessments show SUS can reduce water, energy, and chemical use but increase climate impact and generate hard-to-recycle plastic waste.

Purpose of the Study:

• To summarize evidence on sterility assurance, regulatory drivers, and environmental performance of SUS.
• To advocate for a shift beyond the binary single-use vs. stainless steel debate.
• To promote application-specific optimization and design for disassembly and material recovery for SUS.

Main Methods:

• Review of current evidence and published life-cycle assessments.
• Analysis of regulatory drivers (EU-GMP Annex 1) and environmental initiatives (European Green Deal).
• Commentary synthesizing findings at the intersection of sterility, regulation, and environmental impact.

Main Results:

• SUS adoption is accelerated by regulatory drivers favoring closed, prequalified systems.
• SUS offer environmental benefits in resource consumption but contribute to climate impact and complex waste streams.
• Current evidence highlights trade-offs between sterility assurance and environmental sustainability for SUS.

Conclusions:

• The use of SUS in pharmaceutical manufacturing requires a nuanced approach beyond a simple single-use versus stainless steel comparison.
• Application-specific optimization is needed to balance sterility assurance with environmental performance.
• Future SUS development should prioritize design for disassembly and material recovery to address waste management challenges.