Automated Environmental Monitoring System
Redefining efficiency, safety and precision
Handling settle plates in pharmaceutical environments places high demands on hygiene, reproducibility and process reliability in accordance with EU GMP Annex 1 requirements. Every manual intervention increases the risk of contamination, operator errors and process interruptions. In addition, manual monitoring plates handling is time-consuming, error-prone and resource-intensive.
Challenges of Manual Environmental Monitoring Processes
- Contamination risks: Every gloved intervention increases the risk of microbial and particulate contamination.
- Higher labor requirements: Manual settle plates exchanges require qualified and specially trained personnel.
- Process interruptions: Manual monitoring plates handling slows down operations and impacts equipment availability.
- Annex 1 compliance requirements: Increasing regulatory expectations place greater pressure on aseptic manufacturing processes.
The solution: Automated Environmental Monitoring System for aseptic monitoring processes
groninger has developed an automated solution for the demanding process of environmental monitoring. The system enables the safe transport, precise positioning and automatic exchange of settle plates within enclosed production environments. By minimizing manual interventions, it reduces contamination risks and enhances the efficiency of aseptic environmental monitoring processes.
Precision in every motion. Efficiency in every exchange.
Find out how the automated sytem works:
Complete traceability
Automatic reconciliation of all monitoring plates, including sampling position, plate ID, exposure time and status.
Flexible use
Available for passive and active environmental monitoring, with one system.
Hygienic design
Stainless steel surfaces to support cleaning and disinfection, autoclavable grippers, GMP-compliant sealing materials.
Highly flexible and variable
All Environmental Monitoring Risk Assessment defined critical viable-monitoring positions can be addressed.
Maximum flexibility
Available on all filling lines, from small bath to high-speed commercial productions.
Technologie, die neue Maßstäbe setzt
Innovation setting new standards
- Maximum Flexibility and Versatility: Enables sampling at various heights and positions.
- Space-Saving Design: The robot can be installed in confined spaces without obstructing visibility or access to surrounding equipment.
- Cleanroom-Compatible Design: Stainless steel surfaces enable thorough cleaning and disinfection.
- Unrestricted Operator Access: Flexible standby position allows for necessary manual interventions.
Requirements of modern Annex 1 processes
Why Automated Environmental Monitoring is becoming increasingly important
The requirements for aseptic manufacturing processes continue to grow. EU GMP Annex 1 calls for the consistent minimization of manual interventions in critical areas to reduce contamination risks and ensure sustainable product quality. At the same time, manufacturers face the challenge of increasing production capacity, making efficient use of qualified personnel, and ensuring complete traceability.
The Automated Environmental Monitoring System supports these objectives by reducing manual interventions, standardizing processes, and enabling the reproducible execution of microbiological monitoring activities.
Benefits at a glance
- Reduced manual interventions in Grade A environments
- Improved sterility assurance and process reliability
- Automated and fully traceable monitoring workflow
- Higher production uptime and machine availability
- Reduced operator workload and qualification effort
Discover our innovative solution
Interested in Automated Environmental Monitoring and Annex 1-compliant environmental processes? Our experts are ready to help.
Talk to an ExpertLearn more about the Environmental Monitoring System
What is the Environmental Monitoring System?
The Environmental Monitoring System is an automated solution for viable environmental monitoring in aseptic manufacturing environments. It uses a pharmaceutical-grade 5-axis stainless steel robot to automate settle plate handling for both active and passive monitoring methods.
How does automated settle plate handling reduce contamination risks?
EU GMP Annex 1 requires direct operator interventions in Grade A areas to be minimized wherever possible. Automated settle plate handling removes recurring manual plate exchanges and reduces glove interventions during production.
Which EU GMP Annex 1 Requirements does the system support?
The system has been developed to support several key Annex 1 expectations for aseptic manufacturing. These include minimizing operator interventions in Grade A areas, enabling automated technologies for environmental monitoring, supporting both active and passive viable monitoring methods, and allowing monitoring at risk-based sampling locations.
How does automatic settle plate exchange work?
The solution uses an automated 5-axis robot to position, expose, retrieve, and exchange settle plates at predefined monitoring locations. The robot can access monitoring points at different heights and reach positions without being constrained by its installation footprint. After the specified exposure period, plates can be automatically exchanged, reducing the need for manual intervention while maintaining monitoring continuity.
Why are glove interventions critical?
Every glove intervention in a Grade A environment introduces contamination risk and may disrupt first-air conditions around critical processes. Annex 1 therefore encourages manufacturers to minimize direct operator interventions wherever possible.
Which isolator and cleanroom applications is the solution suitable for?
The solution is suitable for aseptic filling and processing applications where viable environmental monitoring is required. It can address all EMRA-defined critical monitoring positions and supports both active and passive monitoring strategies. With monitoring heights ranging from 100 mm to 350 mm, flexible reach characteristics, and retrofit capability depending on machine configuration and available space, the system can be adapted to a wide range of isolator and cleanroom layouts.