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Pharmaceutical Manufacturing and Packing Sourcer

Enhancing Environments

It would be stating the obvious to say that the pharmaceutical industry is required to meet strict legislation relating to temperature, humidity, CO2, air flow, and differential pressure across almost every stage of the supply chain from manufacturing to retail. Exactly how do these regulations apply in different environments such as fridges, freezers, cryogenic chambers, laboratory incubators, and clean rooms, to name a few? Where are systems most likely to fall down? What can pharma companies do to help themselves stay on the right side of the law and keep their reputation intact?

Incubating Good Habits

Starting at the beginning, the R&D process is crucial. During the development of medical drugs and supplies – which is the bulk of products covered under the pharma banner – a new product could be cycled between a range of temperatures in an incubator, most commonly 37°C-45°C. Any increase in temperature will naturally result in an increase in relative humidity (RH) in the incubator, and, on top of that, labs may be required to operate in a CO2 or oxygen-rich environment.

All of these elements require close environmental monitoring. Additionally, a clean room or aseptic lab should be monitoring conditions either side of the filter and checking differential pressure so that any blockage in a filter will result in an alert, and the problem can be quickly spotted and fixed. For example, a contact lens manufacturer will be monitoring temperature, RH, differential pressure, and other conditions, all within the clean room environment, which is necessary to maintain integrity during the manufacturing and packaging process.

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Marcus Stacey-Bradbury is the UK Commercial Manager atHanwell Solutions, formerly The IMC Group, whose industry-specific environmental monitoring and control systems lead the way in accuracy, radio telemetry, and software. Marcus has particular expertise in environmental monitoring for the pharma and healthcare sectors and works with blue chip clients in those markets across the world.
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Marcus Stacey-Bradbury
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