Efficient reporting

In order to produce products in cleanrooms in a compliant manner, monitoring systems continuously record and monitor quality-relevant parameters such as room pressure, particle concentration, or temperature throughout the entire process. To enable operators to demonstrate these factors seamlessly, the reporting function ensures traceable, uninterrupted, and comprehensive reporting. BRIEM Steuerungstechnik GmbH has integrated an automatic reporting feature into its monitoring system, which can be customized to meet the individual requirements of operators.

In cleanrooms, the extremely sterile production conditions are not just a precaution but a legal requirement: The manufacturing of medical or pharmaceutical products is subject to numerous regulations based on GMP (Good Manufacturing Practice) principles. Measurements such as room pressure and temperature, relative humidity, or particle concentration must not exceed certain limits because these factors significantly influence the quality of the products. Monitoring systems continuously record and document critical physical parameters using environmental sensors or particle measurement devices. It is essential that the data are stored completely and correctly. To ensure this, unauthorized access to the software must be prevented. "For batch release, the operator must be able to demonstrate a clean and flawless production process without gaps," explains Matthias Steck, Project Manager at BRIEM Steuerungstechnik GmbH in Nürtingen near Stuttgart.

For this, the various parameters measured within the room must be collected with timestamps. This function is handled by the reporting component within the monitoring system. This provides the operator with a quick overview of all relevant information recorded within a specified period.

Timely summary of all data

The reporting consists of various modules that can be selected as needed. One example is the audit trail: This records all system interventions with precise timestamps—such as adjustments to limit values or changes to profile settings. Another component is the alarm log, which provides a detailed report of all alarms triggered by limit deviations during production within a specific time window. Additional components include text modules and diagrams for clear presentation. "For safe production in the cleanroom, the reporting must be complete and reliable," emphasizes Matthias Steck. "In addition, flexible reporting is required. For example, daily or batch reports must also be possible."

Save time with automated reports

To avoid scrap quantities in cleanroom production, efficient reporting in daily work and production routines is crucial. This means that if a measurement value exceeds a limit, an alarm must be immediately sent to the responsible employee so they can intervene directly in the production process. Therefore, BRIEM Steuerungstechnik has integrated an automated reporting feature into its monitoring system version 1.4. "The operator creates a schedule specifying when the report should be generated," describes Matthias Steck. This schedule includes, in tabular or graphical form, the measured values of the relevant measuring devices, as well as information about warnings and limit violations, including the time and frequency of each deviation. Digital comments and evaluations document the entire review process by the technical departments. "The automatic reporting also improves diagnostic capabilities to detect environmental anomalies such as open doors or faulty cooling," says Matthias Steck.

The automatically generated reports can then be exported in various formats such as PDF or CSV or printed directly. For maximum efficiency, interfaces to other systems can be implemented. The reports are sent via email to the recipient and can thus be seamlessly integrated into workflows. "With our monitoring system, operators receive a flexible and highly reliable solution for cost-effective production in cleanrooms," concludes Matthias Steck.