Cleanroom Monitoring 4.0

Industry 4.0 or Digitalization 4.0 has been a widely discussed topic in the press, in lectures, and also within companies for some time. Project groups are formed to develop ways for companies to meet this challenge in order to ultimately harness the "digital benefits".

In general, digitalization refers to the preparation of information for processing or storage in a digital-technical system. This involves streamlining processes, accessing this data at any time and from anywhere, as well as the meaningful expansion of information and communication technology.

All these points are essentially nothing new for a successful monitoring system.

In cleanroom monitoring, processes are monitored in real-time with the help of measurement technology, primarily for quality assurance. The goal is to observe a process, systematically record measurement values such as temperature and relative humidity, room differential pressure, airborne particles, air velocity, and other environmental factors within the room. By setting threshold values in advance, interventions can be made if warnings or alarms are triggered. The recorded measurement data are stored unchanged and tamper-proof. Every action within the system, such as acknowledging an alarm, is timestamped to ensure traceability of who did what, when, and how.

As a leading provider, Pharmagraph has elevated its cleanroom monitoring software enVigil to the next level in terms of user-friendliness with the update 4.0. While conventional systems require a dongle to verify license rights, enVigil works with a license key. This means a very high level of security, as a dongle can be lost or stolen, thereby blocking access to the system. This new feature also offers the possibility to monitor activities remotely via an app on a smartphone or tablet from home through a so-called remote access. This ensures that employees can operate within predefined action levels comfortably from home during 24/7 production, without needing to be physically present in the company.

With the electronic signatures supported in enVigil 4.0, processes can be significantly streamlined and simplified. With clearly assignable signing permissions for all users, it is possible to sign documents electronically before printing them, if printing is still necessary; a very time-saving and process-simplifying tool for environmental reasons.

Statistics are important indicators for potentially necessary measures. For example, various histories or activities can be easily compared directly within the software and printed if needed.

In addition to the new features, existing functionalities have also been further developed. For example, more drivers are now available for various devices. Climate cabinets from Vötsch or particle counters from all common providers can be integrated without additional costs.

An additional advantage is the improved ease of maintenance. Entire alarm groups can be deactivated to avoid a flood of alarms, such as via email during maintenance work.

Of course, the software still complies with the requirements of EU-GMP, FDA, GAMP, and many other standards.

The vali.sys GmbH from Wetzikon in Switzerland is a highly experienced manufacturer of complete monitoring systems and offers all services from a single source—from expert consulting, starting with the definition of a suitable system, through delivery and installation, including the creation of all relevant documentation, to maintenance.

As a long-standing partner of Pharmagraph, vali.sys GmbH offers software updates such as version 4.0 free of charge to existing customers.
Many projects lack a holistic perspective. Industry 4.0 or Digitalization 4.0 should not stop at monitoring but rather begin there. After all, the core competencies and essential parts of the company's value chain are monitored here.