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With the revision of Annex 1, the European Medicines Agency (EMA) has significantly tightened the requirements for sterile production environments. Previously permitted manual interventions on the isolator are now only permitted in clearly justified exceptional cases, as any movement through the glove represents a potential risk. Annex 1 requires that such interventions be carried out as part of a risk-based Contamination Control Strategy (CCS) that assesses and minimizes risks throughout the production process.
There is increasing question as to whether certain interventions are necessary or whether processes can be designed in such a way that they can be fully automated or solved via technical systems.
To control the risks in a targeted manner, it is important to know the individual factors that make glove intervention critical.
The influence of glove intervention on the sterility of the product depends on several factors. These include the position of the glove on the isolator, the time in the production process, the duration of the procedure, and the frequency with which it is performed.
Not every procedure is equally critical: a glove intervention in the filling area, directly on open containers, carries a significantly higher risk than an intervention after flanging, when the containers are already closed.
The evaluation of a glove intervention should therefore always be carried out individually to realistically assess the potential risk to product sterility. The variety of processes and systems clearly shows that there is no single solution for evaluating and minimizing glove interventions. Instead, an individual approach is required that considers the specific circumstances of each production environment.
There is no "one-size-fits-all" solution. Instead, modular approaches that combine mechanical, software-supported and AI-based solutions are used. Mechanical aids can position format parts or filling needles, for example, in such a way that glove interventions are minimized. Software solutions make it possible to move components to easily accessible positions or to control interventions via the control panel, thus avoiding critical areas. AI and robotics complement this by detecting misaligned plugs and automatically correcting them.
The ways to mitigate risk are as diverse as the production environments themselves. It is crucial that the solutions are effective, functional, and fit the process and the philosophy of the user. Minimizing glove interventions is not an end, but a central step towards safer, more stable, and future-proof production processes that also meet the requirements of Annex 1.
Optima uses modular solutions that combine the mechanical, software-supported, and AI-based components described above.
