Cleanroom System in Pharmaceuticals


Cleanroom is a part of quality control that intends to enhance the quality of products by limiting the exposure of the products to unwanted particles in the air. Cleanroom in Pharmaceuticals refers to the measure of purity of the air in the room where pharmaceutical products are manufactured or packaged. In simple terms, a cleanroom gives an idea about the size and amount of particulate matters that are present in the air inside the room. In addition, it sets limits for concentration of particles in the room. The concentration of the particles is measured as the number of specific particles per cubic meter of the air. If the particulate concentration goes beyond the limit, the products manufactured in such facilities will not be approved for marketing by the Quality Assurance Department.

According to Federal Standard 209e, cleanroom in pharmaceuticals s are classified according to the amount of concentration of particles in the air. However, the concept of cleanroom does not provide any information about the physical, chemical or radiological characteristics of the particles. Therefore, cleanroom is essentially concerned with the amount of airborne particles. Remember cleanrooms are assigned for industries other than pharmaceuticals. Nonetheless, this classification holds special relevance to the pharmaceutical industries as the regulatory guidelines for manufacture of medications are more stringent than those for others.

A variety of classification systems are used to categorize cleanroom in pharmaceuticals. Each system has its own parameters, and assigns a different class to the room based on the concentration of airborne particles. Some of the common cleanroom standards are governed by:

ISO (International Organization for Standardization)

US FDA (United States Food and Drug Administration)

Federal Standard 209

British Standard 5295

Pharmaceutical Cleanroom Classification

WHO- Good Manufacturing Practice

International Conference on Harmonization Regulations (ICH Q7A)

The documents in the cleanroom standards also have certain sections that guide the use of specific equipments to purify the air according to the industry requirements.

The parameter of cleanroom classification varies on the basis of the formulation of the medication being manufactured. For example, manufacturing facilities for aseptic or parenteral (injectable) products need to have cleaner air compared to those manufacturing topical formulations such as cream, lotion and ointment. Eyes drops or ointments, also called ophthalmic preparations, also need to be sterile just like the parenteral preparations. Hence one can expect similar limits for airborne particulate matters for manufacture of eye preparations. For manufacturing such products, the facilities should also comply with the standard limits for microbial contamination.

There is no doubt over the fact that public health is a very sensitive issue. Medications are used to treat, cure, prevent or diagnose diseases. Therefore they have an explicit effect on the health of the consumers. In essence, medications are more than just chemicals; they can be a poison too. The level of sensitivity increases proportionally when manufacturing injectable or ophthalmic preparations. This is the reason why all the pharmaceutical manufacturing or packaging facilities should strictly comply with the requirements set forth by the governing authority. Hence cleanroom for pharmaceutical is a must.