Why EU’s Annex 1 Is Redefining Sterility Standards

Revised Annex 1 pushes sterilization suppliers toward smarter, data-driven innovation and tighter process control

2 Feb 2026

Europe’s sterilization sector is undergoing a quiet revolution. The revised EU GMP Annex 1, in effect since 2023, is reshaping what it means to maintain sterility. The new framework raises expectations for contamination control, documentation, and process mastery, challenging suppliers to find fresh ways to pair compliance with efficiency.

Unlike older regulations that dictated specific tools or techniques, Annex 1 focuses on outcomes such as strong sterility assurance and clear acceptance criteria. That shift has opened space for innovation. Instead of simply meeting checklists, suppliers are building systems that help manufacturers prove control and consistency without disrupting production. What used to be a behind-the-scenes task is now a stage for smarter design.

STERIS illustrates this transformation with its Verafit™ sterilization bags and covers, which let operators visually confirm dryness at the end of a cycle. Though the regulation does not require such checks, the idea fits neatly with Annex 1’s emphasis on proof and precision. By simplifying verification, STERIS reduces uncertainty and eases inspections without forcing sweeping equipment upgrades.

Automation and digitalization are following the same logic. Hospitals, pharmaceutical firms, and contract sterilizers are investing in systems that boost throughput while tightening control. Getinge, for instance, has developed automated logistics and tracking tools to strengthen traceability. Belimed has focused on advanced handling and monitoring systems that make data central to both efficiency and audit readiness.

Analysts point to a deeper shift taking hold. Compliance is no longer viewed as a box to tick but as a competitive advantage. Tools that simplify proof of control, whether through smarter software or clever packaging, are becoming key differentiators as customers plan for long-term alignment.

The next frontier lies in integration. As packaging, automation, and digital records converge, Annex 1’s influence will keep rippling through sterile manufacturing. What was once a routine requirement is fast becoming a catalyst for innovation.