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Humidification
The critical role of humidification in pharmaceuticals
Maintaining control of the indoor environment is critical in supporting the production and quality of pharmaceutical drugs, as Ryan Reimer, DriSteem product manager explains
T
he pharmaceutical industry has always been on the leading edge of quality and consistency in manufacturing practices.
Managing processes and procedures helps these manufacturers increase productivity, eliminate waste, and ensure product integrity. As the competitive landscape changes, manufacturers of pharmaceutical drugs are looking for ways to increase productivity and eliminate waste to meet the demands of the industry. It is more important than ever to shorten the testing phase to compete, and manufacturers are being expected to develop new pharmaceutical drugs and vaccines at a record breaking pace. Proper humidity control is instrumental in helping manufacturers meet both of these challenges. Product integrity is affected by environmental
conditions within a space and having tight control of humidity, temperature, pressure, air change rate, and particulates will lead to high quality product. Pharmaceutical clean rooms for manufacturing must adhere to strict regulatory standards to be licensed. These requirements ensure sterile and quality-controlled product and include control of relative humidity levels. Optimal conditions and tolerances vary based on the facility, location, room type, and requirements for a specific product. Expanding the view from a singular room to an entire facility illustrates the complexity involved in managing those rooms independently, increasing the variables to be considered like vapor barriers, dedicated/redundant HVAC systems, different pressured rooms, and other isolated systems. Proper humidity levels provide a reduction of dust/particle proliferation, protection against medicine from drying out and becoming brittle, and eliminates issues caused by static electricity. However, too much humidity can increase the risk of viral, bacterial, and fungal growth in the space. High humidity conditions can compromise the cleanliness of the room and have a direct impact on wasted product. The optimal relative humidity range within the production facility, as recommended in the
drugs. A comfortable environment for staff provides additional benefits to the company, including reduced absenteeism due to infection, improved thermal comfort, and better ability to focus. The range for human comfort tends to be between 40 and 60 per cent relative humidity. Too dry of an environment can cause irritation and discomfort from dry skin, eyes, and throat and in addition, increases the likelihood of airborne viral transmission as seen with the seasonal flu and COVID.
Humidification systems have been, and will
“Proper humidity levels provide a reduction of dust/particle proliferation, protection against medicine from drying out and becoming brittle, and eliminates issues caused by static electricity. However, too much humidity can increase the risk of viral, bacterial, and fungal growth in the space.”
ASHRAE Handbook, is between 35 and 60 percent. This can be monitored and maintained through a customised controller that reports data points to a building management system to validate and verify relative humidity levels. In addition to product integrity, there is a human element to be considered during the development and production of pharmaceutical
continue to be, a critical piece of HVAC equipment in the manufacturing of pharmaceutical drugs. Historically, pharmaceutical manufacturing has utilised non-chemically treated isothermal humidification. These technologies boil the water to make steam, which decreases the risk of biological proliferation. However, the current energy climate has brought some change to the industry and adiabatic humidifiers that utilise existing energy in the air to evaporate the water have been increasing in popularity. This technology can provide energy- efficient ways of humidifying a clean room. Both technologies provide good humidification control and can be used to help further the success of production in a pharmaceutical environment. Commercial grade humidification equipment
provides the control needed to maintain proper relative humidity levels – not too low and not too high. Having a customised solution for humidification can help a pharmaceutical manufacturing facility manage installation qualification (IQ), operational qualification (OQ), and process qualification (PQ) goals. Engineers can get assistance with system design from DriSteem representatives who can determine appropriate size and type of equipment based on the application. The team at DriSteem are experts in humidification, designing and building world-class humidification equipment for more than 50 years. DriSteem is committed to helping facilities use those products to protect their people and optimise their businesses
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