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.

Optional barcode scanning perfectly complements the automation of your passive viable monitoring process, enhancing process safety and traceability.

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

Wide range of applications

The Settle Plate Changer is available in two versions:

SPC 1000 for handling non-lockable lids
SPC 2000 for handling lockable lids

Both variants are suited for integration in isolators and RABS.

Small footprint

Both the SPC 1000 and SPC 2000 require minimal space and provide a compact, space-saving solution for your passive viable monitoring process.

Get a free footprint template and see for yourself.

Retrofit solution

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

Honoring an innovative solution

The Settle Plate Changer SPC 1000 was recognized with the prestigious German Packaging Award 2024.

This new development convinced the jury in the category “packaging machines”.

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Higher productivity through automation

The SPC 1000 – an award-winning innovation designed to automate your passive viable monitoring process. Listen to our experts and learn more about the operating principle of this robotic handling unit. Besides meeting the current EU GMP Annex 1 guideline, the patented new development provides numerous other benefits and options to enhance your pharmaceutical production.