Clean Rooms in Pharmaceutical Production
Pharmaceutical production is a critical industry for supporting the healthcare and well-being of the world’s population – is it also a tightly regulated industry with precise methods developed through decades of scientific study. Stringent conditions that must be the same in all circumstances are placed on pharmaceutical production to guarantee that the outputs will be virtually identical in all cases. When administering a sensitive or concentrated pharmaceutical product, even very slight impurities or contaminants could lead to widely varied and undesirable outcomes meaning healthcare practitioners need absolute confidence in what they are prescribing. It is for this reason that clean rooms place a vital role in pharmaceutical production, and in turn medical-grade air purification systems that create clean room conditions like the Air Fit from Aeroex.
How Does Air Purification Help Pharmaceutical Production?
Clean rooms with air purification address many of the quality and safety priorities of the pharmaceutical industry. Common conceptions of how we transmit contaminants could include things like breathing germs, not washing your hands, not having a clean workstation, etc. However, there are actually many airborne contaminants like dust, pollen, aerosols, and bacteria in ambient atmospheric conditions that would interfere with pharmaceutical production if they were not removed. Many of these contaminants are not detectable to the naked eye, meaning incredibly fine filtration or other methods of purification are needed to remove them. This helps the pharmaceutical industry by providing a guarantee that impurities will not enter a product at any stage in the pharmaceutical production process.
Clean rooms can also support other industries as recognized by the recent updates in clean room ISO standards, which cited food production, aerospace, and automotive manufacturing as other applications.
What is a Clean Room for Pharmaceutical Production?
Clean rooms are used in a variety of industries but are most common in pharmaceutical production on account of the previously mentioned quality requirements. According to ISO 14544:2015, clean rooms are specified by “the classification of air cleanliness in terms of concentration of airborne particles”… “based on threshold (lower limit) particle sizes ranging from 0.1 µm to 5 µm”. Clean rooms can provide varying levels of stringency and cleanliness – these standards rang from ISO-1 (the “cleanest”) to ISO-9 (the “dirtiest”).
The most common clean room standards used for pharmaceutical production are ISO-8 and ISO-7. Typically these facilities require a sterile environment but don’t handle hazardous materials. The required air circulation would be around 30 cycles per hour, with approximately 83,000 particles less than one micron in size being allowed per cubic meter of air (this may sound like a lot but not when these particles are incredibly small!).
Higher standards like ISO-5 are typically reserved for specialized technologies like nanotechnologies where even the smallest impurities can have an outsized impact on very small products. These clean rooms typically require unidirectional flow as well, which not all pharmaceutical clean rooms require provided the right purification takes place. To learn more about clean rooms and the breakdown of air purification requirements and methods, check out our recent article on the subject.
Air Purification for Clean Rooms in Pharmaceutical Production
Aeroex specializes in all types of air purification for industries ranging from swiss lathe machining to public schools or hospitals to specialized manufacturing and pharmaceutical production. Our offering for pharmaceutical production clean rooms is the Air-Fit, a clean room system using ceiling-mounted fan filters equipped with the highest standards in air purification technology. The high-efficiency particulate air filter (HEPA) has an efficiency rating of 99.99% for particles as small as 0.3 μm. This rating is notably smaller than the 0.5μm and 1.0μm requirements of ISO-7 clean rooms cited for industries like pharmaceutical production, making the Air-Fit the ideal model for such clean rooms.
Calculate the Air Circulation of a Clean Room for Pharmaceutical Production
Clean rooms are defined not just by the level of cleanliness an air purification system can provide, but at what scale and capacity so as to constantly maintain the cleanliness of facility of a given size/volume. Therefore, the air handling of the air purification system needs to be considered. The Air-Fit comes in two models providing either 500 or 1000 cubic feet per minute of air handling, with speed variations within each. To determine your capacity required to circulate purified air at the necessary frequency (for example 30 times per hour), the volume of the clean room needs to be taken into account. The Air-Fit delivers the high air handling using a centrifugal fan and high volumes of filter media.
In cases where a staged approach to fan filtration was needed, the modular nature of the Air-Fit units and integration with existing mechanical systems could provide the necessary air handling. Typically units should be spaced to provide ambient conditions unless unidirectional flow creates added requirements. If multiple units are deployed, the Air Fit would provide additional benefits (as discussed below) by using a control panel to configure all units simultaneously.
Ways to Improve your Clean Room
Beyond meeting or exceeding the specifications of clean rooms, the Air Fit provides many other benefits to the operation that can improve your clean room. First, our models provide similar air handling to competitor units but do so more efficiently, using a compact model with a smaller footprint to do so when clean room ceiling “real estate” can be in short supply due to lighting, appliances, containment devices, etc. also appearing on the ceiling. Our control panel for configuring multiple Air-Fit units is easy to use, saving an airflow engineering from having to locate and calibrate each unit individually (they’ll thank you for it with a lower invoice!). Our models are designed and manufactured in Canada, giving a long-lasting unit that adds efficiency with long useful life. Our filters use high filter media and rarely clog, leaving you operating longer without a filter replacement. And when you do need to replace the filter you can easily do it yourself thanks to the improved safety we’ve added to the access hatch after seeing issues in competitor models with this process. These benefits combine to improve your clean room and give you greater value.
If you need to establish a clean room or wish to improve or expand an existing facility, contact Aeroex today.