Annex 1 of the EU GMP guidelines creates serious challenges for the pharmaceutical industry – especially when it comes to making sure components that indirectly touch products are sterile. A key problem is the sterile installation of large-volume sorting bowls in high-performance systems. Traditional solutions such as sorting bowls reach their limits here, due to their geometry, which can represent a complexity and a risk for the aseptic setup process.
In this presentation, we will highlight innovative, practical approaches, such as the use of a bowl-free feeding unit. This new sorting solution meets the requirements of Annex 1 and therefore ensures GMP-compliant production. We will discuss the regulatory background and technical implementation details and use a real-life application example to show what technical solutions already look like today.