SPC: automating settle plate changes

Jun 29, 2026 | 3 min read

Complying with Annex 1 implies automation – which is exactly what you can do with our Settle Plate Changers (SPC) 2000 and 4000. Find out more about automated active and passive viable monitoring now!

Key takeaways
              Annex 1 requires settle plate changes every 4 hours
Solutions from Syntegon automative passive (SPC 2000) and both passive and active (SPC 4000) viable monitoring
The result: less manual intervention, higher process safety and machine availability

            

If you are performing aseptic fill-finish operations of liquid pharmaceuticals, you will be confronted with this challenge every 4 hours: According to EU GMP Annex 1, settle plates used manually for viable monitoring must be replaced after no more than 4 hours to ensure the cleanroom quality of sterile pharmaceutical production processes. This not only results in contamination risks but also reduces machine availability.

The good news is: This is thing from the past! You can now rely on fully automated active and passive viable monitoring and increase the change intervals of your settle plates to a minimum of 24 hours. But how is this possible? We will be happy to explain and introduce our automated Settle Plate Changers SPC 2000 and SPC 4000.

The SPC 2000 delivers automated passive viable monitoring and reduces production interruptions and human intervention in the process zone.

Combining active and passive viable monitoring

The SPC 2000 is designed for automated passive viable monitoring. The settle plates are replaced after the prescribed four-hour interval without human intervention. This represents a significant productivity gain. To enable retrofitting on existing lines, it is compact in design and requires no major modifications to the machine base plate. Only a power supply and a data connection are needed. The robotic handling unit, which is suited for integration into RABS and isolators, can be used for both non-lockable and lockable lids and significantly speeds up aseptic manufacturing processes.

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The SPC 4000 combines passive viable monitoring with automated active air sampling for greater sensitivity and highly precise detection of potential bacterial counts.

Since the successful launch and excellent feedback from the industry, we have now taken our SPC portfolio one step further: The SPC 4000 combines passive viable monitoring from the SPC 2000 with an additional step to also automate active viable monitoring. While the automation of this step is not mandatory from a regular perspective, it is highly advisable. Since active air sampling achieves greater sensitivity in detecting potential bacterial counts, the SPC 4000 provides highly precise air sampling. In addition, automation further reduces the need for manual intervention and the risk of contamination, ensures even higher machine availability, and enhances process reliability.

Your benefits at a glance
              Full compliance with EU GMP Annex 1
Reduce contamination risk and increase OEE through process automation
80% less manual intervention for environmental monitoring
Higher machine availability of up to 300 hours per year
Quick and easy retrofitting of existing machines and lines
Full traceability of settle plate changes
Retrofits for all Syntegon lines as well as third-party machines and controls
Standardized interface for transferring exposure data to upper-layer systems

            

Upgrade your fill-finish lines now!

Our SPC 2000 and 4000 are available for new machines and can of course also be incorporated seamlessly into your existing filling lines and any other brands.

Let yourself in on a fully Annex 1-compliant and future-proof solution that enables you to automate viable monitoring, gain noticeably higher machine availability, and considerably reduce the risk of contamination.

Do you want to find out how to increase your machine availability by up to 300 hours per year with an automated Settle Plate Changer? We will be happy to discuss your optimal solution!