Syntegon, a processing and packaging solutions company for the pharmaceutical, food, and medtech industry, has unveiled its latest development.
The new development is a 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 for both new and existing equipment.
Automation in monitoring
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.
Process reliability and traceability can also be increased thanks to optional barcode scanning.
Settle plates may be exposed to cleanroom air for a maximum of four hours and must then be replaced
Steffen Gröber, Global Product Manager Service at Syntegon, said: "Environmental monitoring is essential in aseptic manufacturing and has become even more important in the context of EU GMP Annex 1."
"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," Gröber concluded.
Environmental monitoring has become even more important in the context of EU GMP Annex 1.
Reducing manual intervention
In addition to significant advantages for productivity, the SPC fulfils another important Annex 1 requirement: reducing manual operator intervention in the process zone for environmental monitoring by 80% and thereby minimising the risk of contamination to a minimum.
In the second chapter of Annex 1, automation and robotic systems are particularly emphasised under the keyword “appropriate technologies” for maintaining sterility.
Muhammed Ali Turac, Project Manager of Automation at Syntegon Service, said: "The Settle Plate Changer 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."
The compact Settle Plate Changer is not only available for Syntegon machines but for all machine brands, types, and controls.
Integration in new and existing machines
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,” Gröber emphasised. “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,” Gröber added.
The new SPC from Syntegon will also be presented at the following trade shows:
- CPHI Milan, Italy, October 8-10, 2024, booth 18C33
- Pack Expo Chicago, USA, November 3-6, 2024, West Hall, booth 18099
- PMEC India, Delhi, November 26-28, 2024, booth 12.A03
