Better data quality, no thermal paper, significant time savings: Value creation through digitization in discontinuous cleanroom particle monitoring

Moni.NET Class C focuses on value creation, data security, and simplicity.

Dr. Peter Becker

The topic of digitalization is on everyone's lips and affects nearly all industrial sectors. As a specialist in cleanroom monitoring as well as remote maintenance and IIoT technologies, for more than a quarter of a century, the guiding principle of eurogard GmbH is more relevant than ever: Digitalization is not an end in itself. Digitalization must create added value.

The discontinuous particle monitoring for GMP cleanroom classes B, C, and D is carried out according to our own risk-based approach and is a very labor- and time-intensive activity, with several hundred measurements taken per month and corresponding work hours. Operational processes have been performed 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. Data integrity is ensured through the particle counter's integrated print function, which prints results on thermal paper. Since the readability of information on thermal paper has limited durability, all measurement protocols must be glued, annotated with abbreviations, copied, and archived. To increase the significance of the data or for protocol creation, some numerical values are manually transferred or average values are calculated by staff themselves. This introduces risks of transfer and calculation errors. If mobile particle counters from different manufacturers are used, the overall situation becomes even more complicated, increasing both the workload and the risk potential.

Eurogard offers its customers from sectors such as pharmaceuticals, food, and medical technology the tool Moni.NET Class C, which allows for the optimization of the processes outlined in terms of time, quality, costs, and sustainability. Process times for operational data handling are accelerated, data integrity is enhanced, and resource-efficient approaches are implemented to reduce paper usage. The tool enables automatic configuration of particle counters from various manufacturers (e.g., clean-up time, sampling volume, number of measurement cycles). It features comprehensive user management and a complete audit trail. At the same time, Moni.NET Class C significantly simplifies ongoing administrative tasks: the recorded measurement data are automatically imported from the particle counters (online or offline) and stored in a tamper-proof database. Additionally, charts can be generated based on this stored data. For evaluation, extensive standardized print functions and reports are available, including convenient options for selecting print ranges. There are also functions for displaying limit violations, historical trending of measurement values, and integration of PDF documents such as site plans or calibration documents. Moni.NET Class C is compatible with particle counters from various manufacturers and can be easily integrated into existing IT infrastructures.

The goal of eurogard to increase value creation in discontinuous particle monitoring through digitalization is actively pursued with Moni.NET Class C. The tool stands for future-oriented automatic generation of measurement protocols and documents, including electronic signatures and automated sending to predefined recipient groups. Manual steps previously required, such as filling out, pasting, signing, and copying protocols, are completely eliminated. This results not only in very convenient measurement procedures but also in a significant improvement in documentation quality and a very high economic benefit. As a standard, we recommend Moni.NET Class C as a GAMP5®-validated Category 3 software. This means that only an IQ (Installation Qualification) is required during implementation, with no OQ (Operational Qualification). Of course, customer-specific functions can also be added to the software tool.

Moni.NET Class C: Advantages at a glance:

– Optimized workflow in the cleanroom
– Error-resistant process
– GMP compliant
– Various reports
– Tamper-proof
– Data security
– Historical data
– Audit trail
– Digital signature
– Automated storage and dispatch of protocols
– Easy installation and seamless integration