In the pharmaceutical industry, the demand for aseptic flexible multiformat production lines has increased due to the need for small batches, diverse product portfolios, and compliance with
stringent regulatory requirements, including the new Annex 1 of Good Manufacturing Practices (GMP).
This article explores the challenges and benefits of format change automation in aseptic production. While fully automating aseptic multiformat lines can be challenging and costly, partial automation offers substantial improvements in reducing manual interventions, downtime, contamination risks, and ergonomic challenges. The article emphasizes the importance of a ROI analysis, highlighting historical data to illustrate the potential benefits of investing in automatic multiformat production lines. Drawing parallels with the food processing industry, the article underscores the adaptability of automated lines to handle different package sizes. Despite the complexities, the pharmaceutical industry stands to gain significantly by embracing format automation to ensure sterility, compliance, and product quality.