The requirements for cleanroom and process monitoring are increasing — the new Annex 1 mandates comprehensive control. Innovative solutions for real-time particle monitoring and automated plate changing (APC) enable compliant, reliable, and efficient monitoring of your production environment. At the same time, they ensure maximum safety, reduce manual interventions, and guarantee seamless data integration.
The new Annex 1 requires continuous particle monitoring throughout the entire production process – including systematic data collection, evaluation, and trend analysis.
Real-time monitoring systems enable the immediate detection of microbiological contamination and a rapid response. Optima seamlessly integrates real-time monitoring systems into the SCADA-controlled system of your turnkey line, allowing all collected data to be visualized and processed in real time.
We will be happy to send you the white paper on Annex 1. You will receive an e-mail with a download link.
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 immediate detection of microbial contamination and facilitate a rapid response.
Real-time monitoring systems can be integrated into the system in various ways, such as in front of or next to the production line.
Maximum safety, minimal contamination risks—the Automatic Plate Change (APC) system revolutionizes microbiological environmental and process monitoring in cleanrooms. Automating plate changes reduces manual interventions, ensures data integrity, and meets regulatory requirements (Annex 1). The result is reliable and compliant monitoring of your production environment while increasing efficiency.
Maximum safety, minimal contamination risks—the Automatic Plate Change (APC) system revolutionizes microbiological environmental and process monitoring in cleanrooms. Automating plate changes reduces manual interventions, ensures data integrity, and meets regulatory requirements (Annex 1). The result is reliable and compliant monitoring of your production environment while increasing efficiency.
What question do you have?
We are here for you.
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.