Value creation through digitalization: Moni.NET Class C revolutionizes cleanroom particle monitoring

The ongoing digitalization not only shapes everyday life but also transforms industry. In the field of discontinuous particle monitoring for cleanrooms, especially in GMP cleanroom classes B, C, and D, manual data collection and processing has long been standard practice. However, this approach is not only labor- and time-intensive but also poses risks regarding data integrity. Eurogard GmbH, a renowned specialist in cleanroom monitoring and IIoT technologies, has developed Moni.NET Class C, a groundbreaking tool that not only addresses the challenges of conventional monitoring but also creates added value through digitalization.

Discontinuous particle monitoring for GMP cleanroom classes B, C, and D is typically performed sporadically and is a very labor- and time-consuming activity, often involving several hundred measurements per month and corresponding significant work hours. Operational processes have been carried out in the same, unchanged manner for decades by many cleanroom operators: measurements are taken, data is transferred into databases such as Access, and then commented on and visualized using Excel. The required data integrity is maintained through the particle counter's integrated print function, which prints results on thermal paper. Since the readability of information on thermal paper has a limited lifespan, all measurement protocols must be affixed, annotated with abbreviations, copied, and archived. To increase the informativeness or for protocol creation, numerical values are sometimes transferred manually or average values are calculated by staff themselves. This introduces potential risks of transmission and calculation errors.

Moni.NET Class C addresses these issues and revolutionizes cleanroom particle monitoring through its comprehensive features and user-friendliness. The tool enables automated configuration of various particle counters, import and storage of measurement data in a secure database, and the creation of meaningful diagrams and reports. Process times are drastically reduced, data integrity is increased, and resources are conserved.

One of the outstanding features of Moni.NET Class C is the automatic generation of measurement protocols and documents, including electronic signatures. This not only eliminates manual steps such as filling out, pasting, and copying protocols but also ensures high quality and traceability of documentation.

The latest software release of Moni.NET Class C underscores Eurogard GmbH's innovative strength. New features such as extended audit trails, attachment of documents to reports, and improved communication between software and particle counters offer even more convenience and efficiency. The ability to also use the tool for non-GMP applications and export measurement data as CSV files further broadens its scope of use. Due to the changes in particle limit values in the EU-GMP Guidelines Annex 1 (new version valid from 25.08.2022, mandatory from 25.08.2023), particle limit values can be evaluated according to both the old and the new version. The cutoff date for considering the respective valid limits can be individually defined via configuration setting: measurements taken before this date are evaluated according to the old Annex 1 version, while measurements after this date are evaluated according to the current (new) version.

Overall, Moni.NET Class C offers a comprehensive solution that not only increases the efficiency of particle monitoring but also enhances data integrity and reduces costs. Eurogard GmbH thus sets a benchmark for the future of cleanroom monitoring and demonstrates how digitalization can create added value.

Moni.NET Class C at a Glance

– Efficient measurement processes with support functions
– Data integrity
– Automatic report generation, dispatch, and archiving
– Reports with document attachments (layout plans, calibration documents, etc.)
– Execution lists
– Weekly status reports
– Measurement data export as CSV file (non-GMP)
– Less / no paper
– Electronic signature
– Historical data
– Audit trail
– User management
– Easy integration into existing IT infrastructure
– Validated Category 4 software according to GAMP5®
– GMP compliant (EU-GMP Guidelines, GAMP5®, FDA 21CFR Part 11, ISO 14644)