Applying Data Loggers To Pharmaceutical Industry

Omniflex provides an overview of how data loggers can be applied in the pharmaceutical industry and provides advice on factors to consider when evaluating different data loggers for an application. The ability to monitor environmental conditions easily and reliably is important in many areas of the pharmaceutical industry, according to the company. From the moment that raw materials are received to final product delivery, it is crucial to ensure that factors such as temperature and humidity remain within acceptable limits.

In the case of an out-of-tolerance event, it is essential to be able to quickly pinpoint the location and time of the violation in order to address the problem and get back on track. It is also necessary to be able to provide industry, government and regulators with the data they require in the event of an audit. Today's data loggers are small, low-cost, rugged devices that can take secure, unattended measurements at user-specified intervals 24 hours a day, seven days a week. They monitor a range of environmental parameters (including temperature, relative humidity and light) and are suitable for use in storage, shipping, manufacturing, research and facilities management applications.

They do not require supervision and eliminate the human effort and error associated with manual monitoring operations. Generally, data loggers are small devices that can be installed quickly into the environment to be monitored; they are unobtrusive in laboratories or the process environment. The most advanced loggers can be configured to record data at any interval the user chooses and are supported by user-friendly software that simplifies deployment and data downloading and analysis. Data loggers can be deployed for many applications, from the receipt and storage of raw materials to customer delivery.

For the storage of product and raw materials, the loggers can be deployed around a warehouse or in refrigeration units to monitor humidity, temperature and light levels. For the manufacture of products, loggers might be assigned to individual pieces of equipment to record power use. Alternatively, they can be deployed in work areas to monitor carbon monoxide, temperature and humidity. In research laboratories, loggers fit in incubators, refrigerators, hoods and in general laboratory spaces and can constantly monitor and verify temperature, gases and humidity, for example.

For in-depth assessment, an array of loggers can be deployed in a manufacturing plant or at points around an office building to troubleshoot problems or assess energy efficiency. All data loggers require setup and configuration, but some require more than others. User-friendly loggers can be set up by someone with no training in electrical wiring or programming. The user removes the SD card from the logger and plugs it into a PC with a reader. The data can be read into a spreadsheet and processed.

Remote applications can be connected via networks to a data centre and automatic reports from consolidated and aggregated data can be sent via email to recipients. All data can be stored and accessed via the internet and browsed or downloaded as required. Users should consider the time to be allotted to downloading data. In the most straightforward systems, data download is achieved by connecting the logger via a cable to a laptop or desktop computer equipped with the appropriate software. A removable SD card is far quicker and can be collected and taken back to an office for analysis.

Alternatively, data can be sent to a web-based data centre automatically from multiple loggers at many different locations and data aggregated and processed automatically for the auditors or monitoring bodies. The cost of monitoring manually is high in people equipment and time and is unreliable as a result of the human factor; an automated system does not sleep and is active 24 days a week, 365 days a year. A monthly bill in the same scale as a mobile phone is all that is required. Simple standalone data loggers are suitable for most pharmaceutical monitoring applications. However, there may be situations where a greater data-gathering capacity for multiple parameters is required.

For example, to carry out a complete environmental analysis or verification of a facility's storage facilities, it may be necessary to measure temperature, humidity and light intensity at several points at different locations. Users then need to be able to configure a system with a variety of sensors. Data loggers are suitable tools for monitoring environmental conditions throughout the pharmaceutical industry, from manufacture and storage to research and development. Omniflex claims that the low-cost reliable units collect data when and where it is needed and cut out the time wasting associated with configuring devices or formatting data.