The terms clean room and controlled environment are used loosely in the contamination control industry. We will discuss the key differences between the two environments. When it comes to controlled environments vs. clean rooms, here is what you need to know.
What’s a Controlled Environment?
A controlled environment, also referred to as a critical environment, must control pressure, temperature, and be separated from other operations. Sometimes humidity control is also required, but this is not common. Some laboratories are considered controlled environments as they control temperature, pressure and are separated, but they do not have to meet standards for particle contamination.
What is a Clean room?
Particle control is key when talking about clean rooms. These environments are Classified by the maximum acceptable numbers of particles – by size – in the air per cubic meter. Unlike a controlled environment, clean rooms must meet stringent regulatory requirements with respect to temperature and pressure control and separation from other operations.
Clean rooms need to be tested regularly for compliance with their classification and often require more energy, air, and advanced technology to maintain their required cleanroom conditions.
Clean room or Controlled Environment – Which do you need?
Determining the need for a clean room or a controlled environment depends on the application and the industry. For example, if the application is packaging medical devices, then at least an ISO (International Organization for Standardization) class 7 compliant clean room, or higher is necessary. Whereas a process control laboratory for plating chrome does not require a specific ISO classification but does need a controlled environment.
It is possible to have different requirements within the same facility that require both clean rooms and controlled environments. An example is the need for a controlled storage environment that does not require clean room standards in the same facility with an ISO class 8 clean room for quality control testing.
Clean rooms can be substantial, in fact, an entire manufacturing facility can be contained within a clean room with factory floors covering thousands of square feet. Clean rooms are used extensively in semiconductor manufacturing, biotechnology, medical manufacturing and other fields that are required to minimize environmental contamination.