Sensor SafyrOPC

Real time Particle Counter for Clean Room safety

Sensor SafyrOPC - OEM Module

The sensor SafyrOPC is a high-precision optical particle counter designed for:

• Cleanrooms

• EV Battery Production

• Laboratories

• Pharmaceuticals

• Electronics

• Food and Beverage

and other Controlled environments.

Calibrated to ISO 21501-4 and supplied with an individual Calibration Certificate, it ensures accurate and traceable measurements of airborne particles from 0.3 to 10 µm and with a sampling flow of 2.83 L/min.

The SafyrOPC is resistance to H₂O₂ decontamination with an optimised design for easy cleaning. The SafyrOPC delivers reliable data for current Good Manufacturing Practice (cGMP) compliance, ISO 14644 standards and continuous Clean Room Particulate monitoring.

Sensor SafyrOPC

Addressing Air Quality Challenges in Clean Rooms

Clean Rooms are specialised environments designed to maintain extremely low levels of airborne particulates, pollutants, and contaminants. These controlled environments are critical in sectors such as Pharmaceuticals, Biotechnology, Electronics, Space and Medical Device manufacturing where, even the smallest deviation in air quality can compromise product integrity and safety.

To maintain these standards, ISO 14644 Standard sets the international criteria for Clean Room classification and monitoring, focusing on the control of airborne Particulates and cleanliness.


Ensuring compliance with these standards is not only a technical necessity but also a regulatory requirement in many industries. Tera Sensor
Sensor SafyrOPC solution provides advanced particle monitoring capabilities that help facilities achieve and maintain these stringent standards, ensuring product quality and safety.

Sensor SafyrOPC

Maintaining Air Quality Standards in Clean Rooms​​

Understanding ISO 14644 and Regulatory Compliance​

The ISO 14644 standard defines the Classification and Requirements for maintaining air cleanliness levels in Clean Rooms. It categorises Clean Rooms based on the maximum allowable concentration of particles of specified sizes. For example, an ISO Class 5 Clean Room allows no more than 3,520 particles per cubic meter that are 0.5 microns or larger. Deviating from these requirements can lead to product contamination, increased risk of batch failure, and potential regulatory penalties. In the European Union, Clean Rooms used for Pharmaceutical production must also comply with EudraLex Volume 4, which outlines Current Good Manufacturing Practices (cGMP) specific to the industry. Monitoring systems, such as the Sensor SafyrOPC, that provide continuous real-time data on Particle concentration are crucial for maintaining compliance with these standards and ensuring that the environment remains within the acceptable parameters.

Benefits of Real-Time Air Quality Monitoring in Clean Rooms - Sensor SafyrOPC

Preventing Contamination and Product Loss
Contamination control is the primary reason for strict air quality standards in clean rooms. Particulate contamination can lead to product loss, reduced yield, and compromised product safety. For example, in the pharmaceutical industry, airborne particulate contamination can affect the sterility of products, making them unsafe for human use. Real-time air quality monitoring with sensors like Sensor SafyrOPC provides early warnings of potential contamination, allowing operators to take immediate corrective actions before the situation escalates.

Enhancing Process Efficiency and Reducing Downtime
Maintaining air quality within the specified range also helps reduce the frequency of equipment maintenance and cleaning, leading to increased operational efficiency and reduced downtime. By using continuous monitoring, clean rooms can optimise their air filtration systems, ensuring that filters are replaced only when necessary, based on actual particle load, rather than on a predefined schedule. This data-driven approach can reduce maintenance costs and improve overall process efficiency.

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