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With the implementation of the EU GMP Annex 1 ("Manufacture of Sterile Medicinal Products"), pharmaceutical companies face new challenges, particularly in the fill-and-finish processes. Annex 1 introduces expanded requirements for the operation of both existing and new production lines. Our expert, Ralf Wagner, Sales Director for the DACH region, Portugal, and Spain at Optima Pharma, explains the effects on aseptic packaging and stopper feeding and presents suitable solutions.
A central requirement of Annex 1 is the minimization of manual intervention in the production process, as described in §8.16. While glove interventions are still permitted, they must be analyzed in a strictly risk-based manner and explained in the Contamination Control Strategy (CCS). Automate solutions are therefore essential to reducing interventions and meeting the stringent requirements of Annex 1.
In the processing of the sterilization tunnel, non-automatic approach and empty travel frames or automated empty slide valves can be used. These systems ensure that containers are evenly distributed within the tunnel during production. In the past, such interventions were often carried out manually (e.g., insertion of the start-up/empty gate valve, removal using gloves in the aseptic environment), which, according to the new guidelines, can lead to the exclusion of the affected containers due to the interruption of the air flow. By using automated empty drive systems, these manual interventions are avoided, increasing efficiency and improving product quality and safety.
Another example of innovative, AI-based automation is the removal of misaligned stoppers in the feed lanes using a robotic arm equipped with an autoclavable needle. This technology correlates with camera systems, digital twins, and artificial intelligence to identify incorrectly positioned stoppers without interrupting production and removing them without the need for manual intervention. This solution is also suitable for high-performance equipment, as it significantly reduces the need for glove interventions at critical points in the process, minimizing downtime and possible consequential errors.
Another important process step is the removal of Tyvek cover paper from trays or tubs. Optima has developed an autoclavable solution that minimizes the risk of particle contamination. Suction cups at the edges of the cover paper in combination with deionization rods minimize the risk of particle contamination in containers. This is a critical step toward meeting the requirements of Annex 1 and ensuring product quality.
