Pharmaceutical packaging stores thousands of different medications and solutions each year. Some of these products are extremely volatile and sensitive to contamination, so they must be placed into the cleanest packages possible. To ensure this cleanliness, these packaging products are assembled and packed in clean rooms. Clean rooms are certified by the International Standards Organization (ISO) to ensure the packaging products are as safe as possible. So, when a packaging company claims that their clean rooms is ISO 7 certified that means that their clean room contains no more than 10,000,000 particles larger than 0.1µm in a cubic meter of air. By comparison, room air generally has around 35,000,000 particles larger than 0.5µm in a cubic meter.1
But this still leaves the question, “what is a clean room?” A clean room is a controlled environment that is designed to keep out the outside environment. This involves a certain level of air filtration, particle level stabilization, and minimum human interaction, depending on what classification of clean room is desired. Everyone in a clean room must be fully robed, wearing safety glasses and have a hair net on, and if they are to touch anything, they must be wearing rubber gloves. As mentioned before, a clean room is measured by the number of airborne particulates in the room. All of these precautions are to keep patients safe by preventing contamination of pharmaceutical products from airborne particles, which may change the way a pharmaceutical compound works or cause a patient to fall ill.
1Clean Room Classification Sterile Aseptic Process Regulatory Guide: Clean Room Classification. (2010, February 12). Retrieved December 9, 2015, from http://www.pharmacistspharmajournal.org/2010/02/clean-room-classification-aspects-of.html#.VmiYPrgrKCg