The digital future of discontinuous cleanroom monitoring

In an industry where reliability, efficiency, and compliance with standards are not optional but mandatory, Moqlero by MKL-GmbH sets new standards. As a fully digital platform for discontinuous cleanroom monitoring, it is the top-notch all-in-one solution that revolutionizes the way discontinuous particle measurements, classifications, and re-certifications are conducted.

Leave safety and efficiency to chance

Traditional systems for discontinuous particle monitoring in GMP environments are often fragmented: various devices, separate processes, manual measurements, and paper or Excel-based documentation – error-prone, time-consuming, and expensive. Moqlero ends this complexity. It integrates all relevant processes into a central, cloud-native platform: including automatic report generation, integrated device control, seamless SAP connection, or electronic workflows as part of deviation or change management.

With just a few clicks, an entire measurement process or a complete cleanroom classification/re-certification can be performed, validated, and documented – without media breaks, without paper chaos.

14 measurement methods, 10 particle measuring devices, one system

Moqlero supports all common methods of discontinuous cleanroom monitoring: from classic particle measurement to filter testing or the Clean-Up measurement according to the new EU GMP Annex 1.

Up to six particle counters can be controlled and evaluated simultaneously in parallel measurements – a significant time saving. In addition to the twelve different particle-based measurement methods, Moqlero also supports two air movement measurements with air change rate and volume flow. The platform from MKL-GmbH is compatible with devices from all leading manufacturers.

Automation at the highest level

All particle measuring devices are fully automatically configured, controlled, and read out after measurement. The results are checked and evaluated in real time against defined acceptance criteria. Subsequently, each measurement is securely archived in a digital report and can be retrieved within seconds at any time. In addition to classic reports, long-term trends can be automatically created and analyzed over defined periods. A quick and easy integration into existing systems is another advantage – the system can seamlessly transfer SAP orders via the integrated interface – efficient, secure, and manual effort-free.

Digital excellence meets regulatory safety

The pharmaceutical industry demands the highest standards in documentation, traceability, and security. Moqlero meets these requirements with complete computer system validation, a comprehensive audit trail, tamper-proof reports, and secure processes.

A special feature is the integrated deviation and change management: In case of a detected discrepancy, such as a defective filter, the system immediately notifies responsible personnel via automated alarm functions. The responsible staff are then obliged to evaluate the situation immediately and, if necessary, initiate corrective actions.

Using the electronic signature function within the system, the responsible person can then immediately order and approve a repeat measurement after completing corrective actions. Complete traceability and compliance with GMP requirements are ensured in the process: all activities, including deviation detection, notification, corrective actions, and the commissioning of repeat measurements, are electronically documented and linked to the corresponding order. This provides operational security, even in critical situations.

Trust that has proven itself

More than 25 years of experience in cleanroom technology, combined with state-of-the-art software development, make Moqlero a platform that impresses both technically and strategically. Many market leaders in the pharmaceutical industry rely on solutions from MKL-GmbH – for maximum process safety, efficiency, and quality.

Because in the end, it’s not just about compliance with standards – but about a system that relieves the customer, empowers employees, and makes processes future-proof.