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Globalization, aging population, and economic shifts are transforming the pharmaceutical landscape. New medical needs and therapeutic areas are emerging that will put more pressure on innovation, productivity, and time-to-market. At the same time, sustainability has entered the playing field with a focus on energy efficiency, waste management and emission reduction. All these developments shed a new perspective on the role for air filtration.

Classification Standards
Pharmaceutical cleanrooms and clean air devices are classified according to ISO 14644-1. The level of airborne particulate cleanliness, applicable to a clean area, is expressed as an ISO class. The lower the classification number, the higher the level of cleanliness. The ISO class represents maximum allowable concentrations for considered particle sizes, ranging from 0.1 μm up to 5.0 μm. Figure 2 shows a graphic illustration of the nine ISO cleanroom classes with the concentration limits for the given particle sizes. Different room classes are typically necessary for the various pharmaceutical clean areas and production steps taking place.

The Role for Air Filtration
Especially for aseptically prepared parenteral medicine (such as injectables and infusions), no contamination can be accepted, otherwise severe harm or life-threatening health risks to the patient can result. It is exactly in this area where air filtration comes in as the critical link in the overall chain.