Case Study

Discontinuous particle monitoring

Better data quality, no thermal paper, significant time savings: added value thanks to digitalization in discontinuous cleanroom particle monitoring. The topic of digitalization is widely talked about and affects almost all industry sectors. As a specialist in monitoring as well as remote access and IIoT technologies, eurogard GmbH’s mission statement has been for more than a quarter of a century, and today is more than ever: digitalization is not an end in itself. Digitalization must generate added value.

Discontinuous particle monitoring for GMP cleanroom classes B, C and D is carried out in accordance with the customer’s own risk-based approach and is a very labor- and time-intensive activity that quickly involves several hundred measurements per month and the corresponding number of working hours. Operational processes have been carried out in the same, unchanged way for decades by many cleanroom operators: measurements are made, data is transferred to access databases, for example, and commented on and visualized using Excel. The required data integrity is achieved by the particle counter-integrated printing of the measurement results on thermal paper. Since the readability of information on thermal paper has a limited shelf life, all measurement protocols must be pasted, short-marked, copied and archived. In some cases, in order to obtain a higher degree of significance or for the creation of protocols, numerical values are transferred manually or average values are calculated by the employees themselves. This involves the risk of possible transmission and calculation errors. If mobile particle counters from different manufacturers are in use, the situation is complicated further and the work expenditures as well as the risk potential increase.

With Moni.NET Class C, eurogard offers its customers in sectors such as pharmaceuticals, food and medical technology a solution with which the outlined processes can be optimized in terms of time, quality, cost and sustainability. To achieve this, process times in operational data handling are accelerated, data integrity is increased, and resource-saving approaches are implemented to reduce paper use. The tool can be used to automatically configure particle counters from different manufacturers (e.g. clean-up time, sampling volume, number of measurement cycles). It is also capable of extensive user administration and complete audit trails. At the same time, Moni.NET Class C simplifies the ongoing administrative tasks considerably: the recorded measurement data is imported independently from the particle counters (online or offline) and stored in a non-manipulable database, which can be used to create diagrams. Comprehensive, standardized print features and reports, including convenient selection of the print scope, are available for evaluation purposes. In addition, there are features for displaying limit violations, historical trending of measured values, 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 infrastructure.

Moni.NET Class C forms an essential part in eurogard’s goal of increasing added value in discontinuous particle monitoring through digitalization. The tool stands for future-oriented automatic generation of measurement protocols and documents, including electronic signature and automatic sending to specified groups of recipients. Previously required manual steps such as filling in, pasting, signing and copying the protocols are no longer necessary. This results not only in a very convenient measurement process, but also a big increase in the quality of the documentation and economic benefit. By default, we propose Moni.NET Class C as a category 3 software validated according to GAMP5®. For you this means that you only have to perform an IQ during implementation, not an OQ. Of course it is possible to add customer-specific functionality to the software tool.

We qualify and validate all our software and hardware components in accordance with the relevant regulations and guidelines, taking GMP relevance into account (EU GMP guidelines, GAMP5, FDA 21CFR Part11, ISO 14644).