Pharmacy Cleanroom

In simple terms, a cleanroom is a controlled area within a wider facility that maintains a specific level of air particles and other contaminants. The three ways in which a cleanroom is clean are: The air quality is controlled. All surfaces and equipment are always cleaned to a certain standard.

Cleanroom Classifications:Pharmacy Cleanroom

Cleanrooms provide an enclosed environment with controlled levels of particulate matter (such as dust, vapours and airborne particles). Establishing a cleanroom involves a number of steps including engineering, manufacturing and control strategies. While they are used for a range of medical, scientific and manufacturing applications, we will provide a brief overview of cleanrooms used for pharmaceutical applications that do not handle potent chemicals or hazardous organisms.

Depending on the type of pharmaceutical product you manufacture and federal standards, you may or may not need a cleanroom. A clean area ventilated with filtered air can be used as an alternative to a clean room when producing non-sterile products. You should define your clean zone or cleanroom standards and procedures according to federal standards (e.g. US FED209E) or international standards (e.g. ISO 14644-1 and ISO 14698). For sterile pharmaceutical products, cleanrooms are required to limit airborne particles and contamination from pharmaceutical products. The standards and requirements of a cleanroom are based on its classification and it is important that a room is properly classified as operators need to comply with all requirements and maintain the cleanliness standards for a given classification during operation.