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Cleanroom monitoring is a key component of aseptic manufacturing. Requirements for cleanroom and process monitoring are becoming increasingly stringent – new Annex 1 guidelines call for seamless control.
Innovative solutions like Optima’s automated Environmental Monitoring System (EMS) and real-time particle monitoring systems enable compliant, reliable, and efficient monitoring of your production environment. These systems maximize safety, reduce manual interventions, and ensure seamless data integration.
Address questions Download white paperNew solutions significantly reduce or eliminate the need for manual interventions. Generally, two approaches are applied to achieve this goal: automated Environmental Monitoring Systems (EMS) and real-time particle monitor monitoring systems.
Cleanroom monitoring is a key element of aseptic manufacturing. Continuous environmental monitoring is essential to comply with Annex 1 requirements – and to reduce contamination risks and manual interventions in aseptic filling processes. Optima’s automated Environmental Monitoring System (EMS) provides reliable and efficient monitoring of your production environment. It ensures the highest level of safety, minimizes manual interventions, and enables continuous oversight of critical process conditions throughout manufacturing operations.
Our fully integrated Environmental Monitoring System (EMS) combines PHU passive (Petri dish Handling Unit) passive, PHU active, and the Particle Monitoring System (PMS) into a seamlessly integrated system.
This Annex 1-compliant, automated system, provides continuous monitoring of your production environment while minimizing glove interventions. The result is significantly higher machine availability and a substantial reduction in contamination risk. This patented solution is designed for both new installations and convenient retrofit of existing systems.
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Annex 1-compliant:
Continuous monitoring to meet Annex 1 requirements
Increased efficiency:
No production interruptions during petri dish changes
Enhanced process reliability:
Minimizes manual interventions to the greatest extent possible
Maximum transparency:
Data monitoring can be seamlessly integrated into the batch record
Optima’s integrated Environmental Monitoring System (EMS) combines active and passive Petri dish Handling Units (PHU) with the Particle Monitoring System (PMS) into a comprehensive solution. Perfectly coordinated monitoring zones ensure continuous environmental monitoring and maximize equipment availability.
Automated system for active handling of petri dishes
Automated system for passive handling of petri dishes
Automated particle monitoring system
Our automated Environmental Monitoring System (EMS) can be seamlessly integrated into both new installations and existing production environments. For new machines, an optimally coordinated system architecture is established from the outset. For existing installations, well-designed retrofit concepts enable efficient system upgrades and integration.
For new installations, the automated EMS is fully integrated into the system concept from the very beginning. All components, from particle monitoring to active and passive petri dish handling, are optimally coordinated and directly integrated into the SCADA system.
The automated EMS supports retrofit projects for existing facilities in accordance with Annex 1-requirements. Defined integration concepts enable flexible positioning of system components based on machine layouts and available space. From planning through commissioning, OPTIMA’s service experts provide comprehensive support throughout the entire retrofit process, with the goal of minimizing installation effort and production downtime.
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Would you like to optimize your processes for Annex 1 compliance and learn more about our automated EMS. Our key facts sheet provides a concise overview of the solution, system architecture, operating principles, and key benefits. Download the free fact sheet to gain valuable insights into our solution for both new and existing facilities.
The new Annex 1 guidelines require, among other things, continuous particle monitoring throughout the entire production process, including systematic data collection, analysis, and trend monitoring.
Real-time monitoring systems enable the immediate detection of contamination risks and support rapid response to critical process deviations. Optima seamlessly integrates real-time monitoring systems into the SCADA-controlled environment of your turnkey production line, allowing all collected data to be recorded, visualized, and processed in real time.
Real-time monitoring systems continuously detect airborne particles and microbial contamination (viable particles) to ensure sterile production conditions within the isolator environment.
These systems combine the counting of all particles present within the isolator with the detection of potentially viable particles and microorganisms. The latter is achieved by a method that enables the detection of viable particles through their fluorescence using suitable light sensor technology.
Various real-time monitoring solutions are available on the market. Although providers rely on comparable operating principles, their technical approaches differ. Optima seamlessly integrates systems from multiple providers into the SCADA-based architecture of your turnkey facility, enabling centralized data acquisition, visualization, and real-time analysis of all monitoring data.
Real-time monitoring systems minimize glove interventions and reduce contamination risks, enhancing process reliability through continuous environmental surveillance while supporting Annex 1 requirements for continuous monitoring. By enabling immediate batch release, these systems eliminate the need for lengthy post-process evaluations, reducing operational effort and saving valuable time and resources.
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Precise particle measurement:
Monitors particle count and size, just like a conventional particle counter
Real-time analysis and immediate response capability:
The fluorescence detector instantly identifies viable particles, enabling early detection of potential contamination sources.
Clear identification:
Potentially viable particles are collected for precise identification
Seamless integration:
Connection to the SCADA system for real-time data processing within your production environment
Real-time monitoring systems enable the immediate identification of microbiological contamination and support rapid response to potential risks.
Real-time monitoring systems can be integrated into your production line in various ways, for example either upstream of the line or in parallel.
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Discover how modern equipment concepts and innovative monitoring solutions significantly reduce or eliminate glove interventions while ensuring continuous monitoring.
Download our whitepaper to learn more about Optima’s innovative solutions and how we can help you meet current Annex 1 requirements.
Questions?
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Isolator technologies, RABS systems, and digital monitoring solutions enhance safety and efficiency in the production process. Our fully integrated solutions, including turnkey isolators and CSPE approaches, cover everything from flow optimization to fully integrated Factory Acceptance Testing (FAT) for maximum safety. Additionally, the intelligent use of robotics – leveraging software and automation, including AI – reduces glove interventions.
The validation and qualification of cleaning and disinfection processes are essential for safe production workflows. We offer solutions such as PUPSIT (Pre-Use Post-Sterilization Integrity Test), effective sterilization methods for freeze dryers, and automated loading and unloading systems to optimize efficiency and compliance.
A wide range of innovative technologies help you master key production challenges. Whether it’s new acquisitions, modernization, process optimization to prevent contamination, or risk management – we offer carefully planned, field-tested solutions.
