SafyrOPC

Optical Particle Counter for Continuous Monitoring

SafyrOPC

Compliant Particle Load monitoring for cGMP facilities and ISO 14644 environments.

SafyrOPC is a portable or fixed, complete Packaged Instrument, solution for Real-Time Particulate monitoring in:

> Cleanrooms

> Laminar flow hoods

> Biosafety cabinets.

Combining the SafyrOPC Optical Particle Counter (ISO 21501-4 calibrated) with a LoRa gateway the SafyrOPC allows Teams to perform fast, reliable continuous checks in compliance with regulatory audits.

Resistant to H₂O₂ decontamination and offering up to 168 hours of battery autonomy, the SafyrOPC Instrument ensures continuous, compliant monitoring for cGMP facilities and ISO 14644 environments, reducing downtime, costs, and compliance risks.

Benefits of Real-Time Air Quality Monitoring in Clean Rooms

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 NextPM 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 optimize 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.

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 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.

Impact of Poor Air Quality on Clean Room Operations​

Even small fluctuations in particle concentration can significantly impact Clean Room operations. Contaminants such as dust, bacteria, or chemical vapors can lead to defects in semiconductor manufacturing or contamination in pharmaceutical products. This can result in costly recalls, damage to reputation, and potential legal repercussions.