Syntegon has showcased an important new development at ACHEMA 2024 that generated a great deal of interest among pharmaceutical manufacturers: the patented Settle Plate Changer (SPC) for automated viable monitoring in the aseptic filling process.

With this innovative solution, Syntegon will support customers in complying with the latest Annex 1 both for new and existing equipment.

“Environmental monitoring is essential in aseptic manufacturing and has become even more important in the context of EU GMP Annex 1,” said Steffen Gröber, Global Product Manager Service at Syntegon.

Settle plates may be exposed to cleanroom air for a maximum of four hours and must then be replaced to ensure consistent sampling for liquid filling operations. With the new robotic handling unit from Syntegon, this step can now be performed automatically, siginificantly reducing the previously required production interruptions.

“Thanks to the SPC, machines only need to be stopped once a day for viable monitoring, which results in noticeably higher machine availability of up to 300 hours per year and therefore more sustainable processes,” added Gröber.

Process reliability and traceability can also be increased thanks to optional barcode scanning. In addition to significant advantages for productivity, the Settle Plate Changer fulfills another important Annex 1 requirement: reducing manual operator intervention in the process zone for environmental monitoring by 80 percent and thereby minimizing the risk of contamination to a minimum. In the second chapter of Annex 1, automation and robotic systems are particularly emphasized under the keyword “appropriate technologies” for maintaining sterility.

“The SPC reflects our commitment to meeting regulatory requirements at all times and to always putting customer needs first. Even before Annex 1 came into force, we started developing our automated solution and secured the patent,” said Muhammed Ali Turac, Project Manager Automation at Syntegon Service.

The Settle Plate Changer from Syntegon is available both with the purchase of a new machine and as a retrofit for existing equipment.

“What's more, it can also be seamlessly integrated into all machines and control systems from third-party suppliers. As a result, we ensure that the service life of existing equipment is increased and pharmaceutical manufacturers can run more sustainable processes thanks to reduced downtimes,” Steffen Gröber emphasized.