Keep the cleanroom always in view

This is what a monitoring system based on Moni.Net could look like. (Image: Eurogard)

View of the dashboard of the IoT platform m2v. (Image: Becker - Eurogard)

The m2v engine structures incoming data streams from various sources, calculates key figures, visualizes KPIs, and serves as the basis for all customer-specific and individually definable digital services. (Image: Becker - Eurogard)

Digitalization creates added value. Especially in the areas of data-driven decision-making and process optimization, cleanroom operators such as pharmaceutical and life science companies can unlock many potentials for themselves. Often, a digital infrastructure already exists, consisting of, for example, cleanroom monitoring, SCADA, MES, or ERP systems, as well as various digitized machines and equipment. These data sources can be used to develop individual use cases: live data visualization, (remote) alarm notification, optimized risk management including process optimization, increased process safety through preventive measures, to name just a few examples.

As a provider of GMP-compliant cleanroom monitoring systems as well as IIoT solutions, eurogard can offer its customers a proven software landscape that allows different data sources to be easily linked and utilized through IIoT applications.

Integration of various software solutions

Cleanroom Monitoring System

In addition to the obligation to monitor a cleanroom to meet regulatory requirements, cleanroom operators are increasingly intrinsically motivated to operate a cleanroom environment monitoring system that enables them to monitor and optimize status and processes based on data. With the product Moni.NET, eurogard offers its customers a customizable monitoring solution built on standard modules. Thanks to non-proprietary hardware, installation in existing IT infrastructures is seamless.

With Moni.NET, all measurement data are collected centrally and stored securely against manipulation. Customer-specific visualization, automated alarm notification in case of limit violations, GMP-compliant documentation, and automated processes support efficient operational work. Thanks to Moni.NET, batch protocols can be automatically generated, saved with customer-specific filenames, automatically sent to predefined distribution lists, and electronically signed. This allows Moni.NET to enable fully paperless batch documentation within regulated processes.

Info Box: Functions of Moni.NET

– Custom, customer-specific solution
– Batch documentation and control
  – Statistical data analysis
– Visual data presentation
– Automatic report generation with extensive attachments
– Electronic signature
– Simple user management via LDAP / AD
– Independent of measuring device / sensor manufacturer
– Client/server architecture
– Audit trail
– Alarm notification: acknowledgment and documentation
– Highest availability and usability
– Highest data security and data integrity

Of course, Moni.NET complies with all regulatory requirements according to GAMP®5, FDA 21 CFR Part 11, EU-GMP guidelines, ISO 14644. However, the recorded data can also provide many value-adding insights outside the GMP environment. For further use and processing of these cleanroom parameters, it is advisable to transfer the data into a non-GMP application. The eurogard machine to value (m2v) IIoT platform is introduced below as a suitable tool for this purpose.

IIoT Platform

The "m2v" IIoT platform is a highly integrative software that combines various, extensively tested and validated open-source microservices built on the latest, secure technologies. The m2v engine structures incoming data streams, calculates key figures, visualizes KPIs, and serves as a flexible system for all customer-specific and individually defined digital services.

Data sources such as the previously outlined Moni.NET software can be easily integrated into the m2v platform via interfaces. The same applies to data management systems like LIMS, MES, or ERP systems. Additionally, existing plants and machines, as well as data from building automation systems, can be connected to the platform using eurogard Edge Devices. This allows various "Data Lakes" to be created within a system with minimal effort, which can then be correlated with each other seamlessly.

Recording different process and operational data results in a completely new starting point for cleanroom operators to analyze and evaluate their processes and statuses in real-time and historically. This insight forms the basis for any optimization in productive, organizational, and administrative processes.

Value Creation: Visualization and Alarm Notification

A customer-specific use case involves visualizing all common GMP-relevant cleanroom monitoring parameters as well as machine and equipment status on a dashboard. Additionally, current weather data from the in-house weather station are displayed as color-coded metrics, since extreme weather events can influence climate control. With this browser-based application, employees always have all relevant KPIs in view via dashboards, are alerted in case of limit violations, and can retrospectively analyze historical data and draw conclusions.

Value Creation: Cost-Optimized Cleaning Using AI Application

Technical cleanliness and contamination control are mandatory in cleanrooms. It is therefore extremely important for operators to know what (process, machine, staff, etc.) contaminates the cleanroom and how potential sources of contamination can be identified and subsequently eliminated. Thanks to data collection via the m2v platform, monitoring, machines and equipment, ERP, and weather data can be easily collected and stored in a structured manner within a database management system. This data treasure can now be analyzed using AI algorithms to detect anomalies. For example, contamination spikes can be traced back to specific operating points of a machine, particular weather events (e.g., pollen flight), individual employees, or special material usage. From these insights, cleaning intervals can be derived to ensure the required cleanliness is always maintained while avoiding unnecessary cleaning cycles.

The core IIoT use case of a company is always highly individual and must be prepared accordingly. However, the technical setup is always the same. By combining existing data sources into an IIoT platform, various added values can be generated for cleanroom operators with minimal effort.