Environmental monitoring solutions

Environmental monitoring is essential in aseptic manufacturing. However, any interventions for continuous viable monitoring pose a risk to the sterile process. Especially human factor is unpredictable and intervention not reproducible.

To mitigate these risks in the sterile process zone, also in the light of the latest EU GMP Annex 1 guideline, the automation of environmental monitoring is key.

Automated change
of settle plates

According to the EU GMP Annex 1 guideline, continuous microbiological monitoring of pharmaceutical production must be ensured. For viable monitoring this means that settle plates may be exposed to cleanroom air for a maximum of 4 hours.

To comply with all applicable regulations, while increasing process safety and reliability, we developed a robotic handling unit for changing the settle plates during ongoing pharmaceutical production.

By using our patented Settle Plate Changer as appropriate technology, the frequency of manual interventions for passive viable monitoring can be reduced significantly. The automation of this process through our innovative device allows you to increase the interval for manual intervention to a minimum of 24 hours.

In addition to gaining noticeably higher machine availability, you can considerably reduce the risk of contamination due to manual intervention by the operators.

The Settle Plate Changer is available for new machines or can be incorporated seamlessly into your existing filling lines from Syntegon and any other brands.

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Your benefits

Process safety

Reduction of manual interventions for environmental monitoring by 80 %

Compliance

Ensuring the current EU GMP Annex 1 guideline

Performance

Increased machine availability by up to 300 hours per year

Settle Plate Changer

With the Settle Plate Changer, the machine only has to be stopped once a day for viable monitoring.

Thanks to optional barcode scanning, you can enhance process safety and traceability.

Settle Plate Changer

Retrofit your machines now:
Our compact Settle Plate Changer is not only available for Syntegon machines but for all machine brands, types, and controls