CPHI Milan 2024: Compliance and Automation in Aseptic Processing

It has been a little over a year since the European Union’s Annex 1 revisions came into force (1), meaning that companies manufacturing sterile medicinal products should be compliant with the new version of the regulatory guidance. However, the road to compliance for any regulatory change is often fraught with challenges, and for Annex 1, Klaus Ullherr, senior product manager at Syntegon, highlights two in particular that he has encountered as a machine builder.

The first challenge to overcome is that of maintaining clean air, so, ensuring that the air flowing down from above onto the machine does not come into contact with anything prior to reaching the product, Ullherr notes. “The second [challenge],” he continues, “is the aseptic setup, meaning that you now have to have autoclave parts.”

A key aspect helping to overcome challenges and ensure compliance is employing more automated solutions in the aseptic processing line. Automation also reduces human intervention, which is critical as humans pose a huge threat to product quality through potential contamination, Ullherr asserts.

Furthermore, automated systems allow for processes to be performed completely reproducibly, Ullherr continues. “We know from presentations from FDA that many deviations within pharma are caused by human error,” he summarizes. “The automation of processes really gives us the opportunity to reduce these deviations significantly.”

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Reference

1. EC. Annex 1 Manufacture of Sterile Medicinal Products. EudraLex Volume 4, August 2022.

Visit Syntegon at Booth 18C33. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.

About the speaker

Klaus Ullherr, senior product manager, Syntegon

Klaus Ullherr is a senior product manager at Syntegon with a University degree in electrical engineering. Before joining Syntegon in March 2000, he worked as a project manager in the electrical industry for several years. At Syntegon, his main responsibilities include global product responsibility, market analysis, and initiating new product developments. He is a member of the PDA and works as an expert in the DIN/ISO group for primary packaging. Klaus is also a member of ISPE and a well-known speaker and trainer covering trends and solutions for fill/finish equipment.