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9/5/2018

Case: Monitoring humidity and temperature in the pharmaceutical industry with a validated system

When we talk about health care, all caution is fundamental: physical or chemical changes in medications can even result in the loss of their effectiveness. Hence the importance of rigorous and adequate temperature and humidity control in pharmaceutical industry environments, such as laboratories and clean rooms. A company of the segment, located in Barueri, in the São Paulo metropolitan area, presented a challenge to NOVUS: implement a monitoring system in its new facilities, without causing changes in infrastructure. The main objective of the company was to obtain the release of the laboratory from the regulators for the production of the formulas, so that the assembled system should be validated.

There are rules, such as ANVISA’s RDC 17/2010 and FDA21 CFR Part 11, which provide for good practices and drug manufacturing. Among the obligations is the monitoring of ambient temperature and relative humidity recording system used in storage and handling environments of drugs and immunological, considering the requirements of each type of product. The data collected and recorded must be kept for up to five years and be available for consultation. With the recorded information,  is possible to trace batches of products handled by the laboratory, thus ensuring the manufacturer's quality assurance.

For this case of 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, with products that guarantee reliable reading and storage of data and safety. The fact that only one supplier - NOVUS - offered the whole solution was an essential point for the company to close the deal, since it would buy not only the products but also the installation, calibration and validation of the system. NOVUS is a manufacturer of solutions that brings a lot of reliability to the customer, mainly because the laboratory would know who to turn to in the case of design adaptations or repairs.

The project installed in Barueri's laboratory consists of four data acquisition panels, composed of FieldLoggers - a high performance, high resolution and speed variable reading and register module - and AirGates Modbus, which acts as a connection interface between a network with Modbus RTU protocol over RS485 and a wireless network with proprietary protocol over IEEE 802.15.4. In addition, the project has four repeater panels, also equipped with AirGate Modbus.

But the highlights of the installation are the 84 RHT-Air. Fully wireless solution for measuring temperature and humidity over long distances, the RHT-Air allows the configuration and reading of the parameters through the wireless network, IEEE 802.15.4 protocol, in up to 1 km, bringing practicality and efficiency to the application. Because it works without cables and wires, it has a simplified installation, without the need for structure changes in the structure of the building, making it the ideal option for the Barueri laboratory. If there is a need to extend the telemetry network, simply attach the new sensor where necessary and configure it at a distance! Finally, RHT-Air operates on its own wireless network, without the need to use the company's IT infrastructure, allowing its stand-alone operation.

Since the system is validated within the standards, the application will already have the pay-back if it passes its 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. In addition, NOVUS's ability to negotiate required conditions and the company's know-how in the health sector were fundamental in the choice.

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