Cubic Cleanroom Airborne Particle Monitoring Solutions Empowering Pharmaceutical Industry

Cubic Portable and Online Optical Particle Counters for Airborne Particle Monitoring Across Pharmaceutical Utilities, Manufacturing, and Personnel-Related Areas

Growing Demand for Airborne Particle Monitoring in Pharmaceutical Industry

Pharmaceutical manufacturing is commonly conducted in cleanrooms or controlled environments, where airborne particles must be carefully monitored and controlled across utilities, manufacturing areas, and personnel-related areas, since small airborne particles can affect product quality.

The demand of particle monitoring is reinforced by international standards and expectations. ISO 14644 defines cleanroom classification based on airborne particle concentration. Moreover, GMP emphasize risk-based environmental monitoring to verify that critical cleanroom areas remain controlled during pharmaceutical production.

Driven by the industry practice and international standards requirements, pharmaceutical manufacturers need reliable instruments that can provide quantitative, real-time, and traceable airborne particle data. Optical particle counters (OPCs) are therefore in critical demand as key instruments for non-viable particle monitoring, supporting contamination control and compliance in pharmaceutical industry.

Cubic Cleanroom Airborne Particle Monitoring Solutions for Pharmaceutical Applications

In pharmaceutical cleanrooms, airborne particle monitoring is required across three major application scenarios: manufacturing areas (e.g., filling lines and biosafety cabinets), where continuous monitoring is critical, as well as utilities (e.g., HVAC systems and compressed gas) and personnel-related areas (e.g., airlocks and gowning rooms).

To provide different optical particle counter configurations in different scenarios, Cubic, a leading manufacturer of gas sensors and analyzers, has developed the Portable Optical Particle Counter OPC-6511DS and the Online Particle Counter with Display OPC-6510DS based on light scattering technology for the precise measurement of airborne particles in critical pharmaceutical cleanroom applications.

• Cubic Online Particle Counter with Display OPC-6510DS
Online optical particle counters are mainly used in manufacturing areas for continuous non-viable particle monitoring at critical sterile process points. They are especially important for ongoing environmental monitoring in high-risk Grade A sterile operations, such as filling zones, open ampoules or vials, and aseptic connection points.

To support manufacturing-area monitoring, Cubic Online Particle Counter with Display OPC-6510DS features a built-in laser particle counter module, a constant-speed fan, and an ultrasonic flow sensor, delivering accurate measurements and a stable sampling flow rate to support pharmaceutical manufacturers in complying with ISO 14644-1 requirements. Moreover, the optical particle counter features a SUS304 stainless-steel enclosure for durability in pharmaceutical cleanrooms. Built-in data storage supports reliable monitoring records. Online monitoring software enables real-time data visualization and monitoring. By continuously monitoring critical locations during production, Cubic online optical particle counter enable real-time alarms, operator notifications, response logging, and data support for batch release and contamination control.

• Cubic Portable Optical Particle Counter OPC-6511DS
Portable optical particle counters provide flexible, point-to-point airborne particle monitoring across utilities, manufacturing, and personnel-related areas in pharmaceutical facilities. They support cleanroom classification, routine verification, contamination investigation, and re-monitoring after corrective actions.

In response, Cubic Portable Optical Particle Counter OPC-6511DS features high accuracy, fast response, and multi-channel detection, supporting efficient clean-room verification and contamination source investigation. To support compliance-oriented monitoring, OPC-6511DS provides ISO 14644-1 clean-room grade display for on-site clean-room assessment. In addition, OPC-6511DS supports RS485 Modbus RTU and RJ45 MQTT communication, enabling seamless integration with various instruments. A built-in rechargeable battery is designed for extended and mobility use across multiple clean-room locations.

Cubic cleanroom airborne particle monitoring solutions help pharmaceutical manufacturers build a more complete airborne particle monitoring framework across utilities, manufacturing areas, and personnel-related scenarios. By providing reliable particle monitoring across different applications, Cubic supports compliance-driven monitoring while strengthening contamination control throughout the entire production cycle, with solutions customizable to specific monitoring and integration requirements. Through continuous innovation in particle monitoring technology, Cubic is committed to supporting the evolving demand of modern pharmaceutical manufacturing.

For more detailed information, please visit https://www.cubic-controls.com/products/optical-particle-counter/ or contact us via [email protected]