Monitoring Provides Process Validation in the Pharmaceutical Industry

CLEVELAND - Dec. 9, 2019 - PRLog -- Process validation in the pharmaceutical industry is critical; physical or chemical changes in medications can result in the loss of their effectiveness. Hence, rigorous and adequate temperature and humidity control in pharmaceutical industry environments, such as laboratories and clean rooms of storage areas, is of great importance. A company located in Barueri, in the São Paulo metropolitan area, presented a challenge: implementing a monitoring system in its facilities without requiring rewiring or other changes in infrastructure. The main objective of the company was to obtain the release of new drug formulations from the laboratory to production, which required approval from the regulatory agencies and necessitated that the assembled monitoring system be properly validated.

Installation

For the laboratory in Barueri, NOVUS came up with a turnkey solution that could fulfill all customer needs: to set up a remote monitoring system without modifying the structure, products that guarantee reliable measurements, storage of data, compliance with regulatory requirements and process validation. The fact that only one supplier offered the whole solution was a key point in closing the deal since the company would buy not only the products but also the installation, calibration, and validation of the system.

The project installed in Barueri's laboratory consists of four data acquisition panels, composed of NOVUS FieldLoggers– high performance, high-resolution data loggers – and AirGate Modbus receivers, which act as a connection interface between the data loggers and the wireless transmitters using the industry-standard Modbus RTU protocol. In addition, because of the size of the facility, the project has four repeater panels, also equipped with AirGate Modbus modules.

But the highlights of the installation are the 84 RHT-Air transmitters. A turn-key solution for measuring temperature and humidity over long distances, the RHT-Air allows the configuration and reading of the parameters via the wireless IEEE 802.15.4 protocol, over distances of up to 1 km, bringing practicality and efficiency to the application. Because it works without cables, it has simplified installation, eliminating the need for changes in the structure of the building, making it the ideal option for the Barueri laboratory.

Benefits

Since the system is validated within the standards, the application will already achieve payback when it passes its first audit. The main reason the customer chose NOVUS was the ability to obtain everything needed from the same supplier, gathering all the necessary aspects for the system's implementation, including ease of implementation, wireless technology and the flexibility of the solution to expand.

For more information on the Novus RHT-Air, or to find the ideal solution to your specific application, contact a CAS Data Logger Applications Specialist at (800) 956-4437 or visit us at https://www.dataloggerinc.com/