FDA Cleanroom Requirements

The Food and Drug Administration oversees the research and development of new medical products, both devices and pharmaceutical products, by private companies. The FDA requires all products to be tested and manufactured in a FDA-certified clean room. A clean room is a controlled environment, which filters all incoming air to remove all dust particles and possible contaminants that may interfere with production. In order for a clean room to be FDA certified, it must meet the clean room standards for controlled environments set forth in US documents FED-STD-209E or ISO 14644-1.

In order for clean rooms to maintain sterile environments, personnel who enter into clean rooms are required to wear protective clothing and enter through airlocks.

Particle Contamination

• There are three major sources of particle contamination: supply air, infiltration air, and internal generation.

  Supply air particle contamination occurs when particles enter into the clean room by air supplied through exterior pipes. This form of contamination is stopped by the application of an air filter to the incoming air vents.

  Infiltration air particle contamination happens when particles enter the clean room via leaks or fissures in the protective walls of the clean room. These particles are stopped by testing daily to locate leaks and sealing them quickly to stop the spread of contaminated particles and prevent more contamination.

  Internal generation particle contamination is contamination derived from devices or chemicals inside the clean room. This form of contamination is stopped by the rapid removal of the toxins or particles and the removal and replacement of all the air within the clean room through replacement vents.

Clean Room Pressurization

• Clean rooms need to maintain constant pressure to lower the possibility of contamination particles entering the clean room, as well as to assist in the removal of contaminated air from inside the room. Pressurization is one of the primary requirements to receive FDA certification for the clean room.

Clean Room Monitoring

• Due to the necessity of maintaining a sterile environment inside the clean room at all times, clean rooms often have computer systems monitoring all areas (walls, vents, air pressure, etc). These systems are designed to detect any irregularities and react accordingly to prevent contamination.