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Cleanrooms are the backbone of industries where extreme hygiene, air purity, and tightly controlled environmental conditions are critical—such as in pharmaceuticals, semiconductor manufacturing, biotechnology, and medical technology. In these environments, even the slightest deviations in temperature, relative humidity, particle concentration, or pressure gradients can have major consequences for product quality, safety, and regulatory compliance.
Monitoring is therefore not a luxury, but a necessity. By continuously and accurately measuring environmental parameters, operators can ensure that the cleanroom functions within the required specifications. This is essential not only to prevent contamination, but also to comply with strict regulations such as GMP (Good Manufacturing Practice), ISO 14644, or FDA guidelines.
sAInce.io is an expert in developing advanced monitoring and industrial IoT solutions. In addition to custom developments—typically carried out as co-creation projects—sAInce.io has also developed an advanced monitoring solution based on its proprietary IIoT framework (IIoT Verse). This solution, called CleanShield, is specifically designed for cleanroom monitoring.
A reliable monitoring system detects anomalies in real time, generates automatic alerts, and logs all data for audit purposes. In this way, monitoring forms the foundation for quality assurance, risk management, and process optimization in cleanroom environments.
Monitoring in cleanrooms is essential, but it comes with specific challenges. Sensors must be highly accurate and reliable, and require regular calibration. The volume of data is significant and must be processed in real time without interruption. Integration with existing (often legacy) systems can be technically complex. Alerts must also be intelligent and targeted, avoiding unnecessary noise. Furthermore, strict requirements apply to data management and audit trails, with a strong focus on regulatory compliance.
CleanShield is the ideal solution for monitoring environmental parameters in cleanrooms. It is an advanced, dynamic system that delivers the critical success factors of a modern monitoring solution in a smart and efficient way:
Easy installation, resulting in lower installation costs
Energy-efficient operation
No downtime during calibrations
Seamless integration with existing systems
Fully configurable and modular, allowing features to be activated or scaled up as needed
Fully cybersecure
Fully compliant with the strictest industrial standards for environmental monitoring, such as GMP Annex 1, FDA 21 CFR Part 11, and ISO 14644
Utilizes accurate, high-quality sensors
Installation is plug & play. The central IoT controller is the size of a shoebox and replaces a complete electrical cabinet. In addition, daisy-chaining with connect & play boxes enables both simple installation and easy expansion with extra sensors and monitoring points.
Wi-Fi is supported, allowing sensors to be deployed in dynamic locations — for example, to collect data during qualification procedures.
Sensors can be replaced with pre-calibrated ones, so calibration can take place offline in a calibration lab — without any downtime at the local site and without losing traceability. The system always knows exactly which sensors (by serial number) are installed where.
The system is fully configurable and dynamic: the customer decides which visualizations to display, which alarms to trigger, which report templates to use, which dashboards to configure, etc.
Full support for e-signatures, with advanced features like bulk comments and extended annotations.
The current valid calibration certificate is always available in the central application.
Historical data is available for full traceability in an electronic logbook, including advanced search functionality (e.g. where a sensor was used, calibration certificate history, etc.).
Analytical capabilities via the central application: graphs can be configured and queried historically, with automatic zooming, graph linking, time-travel features, and more.
Supports a wide range of sensor types: CO₂, temperature, humidity, pressure differentials, door contacts, air velocity, radiation levels, particle counting, etc.
Available both in the cloud and on-premises.
Contamination prevention through real-time alerts: Immediate warnings in case of deviations (e.g. particle counts or pressure differences) enable rapid interventions, preventing contamination before it affects the production process.
Reduced product loss and errors: Continuous monitoring and automatic logging of environmental parameters allow early detection of process deviations, resulting in fewer rejects, less scrap, and greater process reliability.
Full traceability and audit readiness: Every parameter is automatically recorded, digitally signed, and securely stored, providing a complete digital logbook ready for audits or inspections, compliant with GMP and FDA 21 CFR Part 11.
Faster and simpler qualifications: Automatic data collection and reporting streamline cleanroom qualifications or requalifications, making them faster, more consistent, and less prone to manual errors.
Improved calibration and maintenance processes: Thanks to offline calibration, existing installations remain operational, supporting uninterrupted production workflows.
Scalability and integration: The system easily scales with additional rooms or equipment and integrates seamlessly with existing SCADA, EMS, or BMS systems.
Support for data-driven optimization: Historical and real-time data enable trend analysis, bottleneck identification, and continuous process improvement.
CleanShield demonstrates how smart, reliable monitoring plays a crucial role in managing cleanroom environments safely and efficiently. Through continuous monitoring, instant notifications, and full traceability, the system ensures not only air quality and environmental compliance but also delivers operational advantages. Without interfering with existing processes or installations, CleanShield enables faster response, smarter reporting, and constant audit readiness. In doing so, we set a new standard for data-driven quality assurance in regulated and critical production environments.