Often cleanroom and controlled environment designations are used interchangeably to refer to the necessary environment control required in critical spaces. There is, however, a crucial difference between the two. When it comes to controlled environments vs. cleanrooms, here is what you need to know.
What is 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 not often. 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 Cleanroom?
Unlike a controlled environment, cleanrooms must meet stringent requirements with respect to temperature and pressure control and separation from other operations. Classified by the maximum acceptable numbers of particles – by size – in the air per cubic meter.
Cleanrooms must be tested regularly for compliance with their classification and often require more energy, air, and advanced technology to maintain their required cleanroom conditions.
Cleanroom or Controlled Environment?
Which do you need?
Whether a particular application requires a cleanroom 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 cleanroom, 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 cleanrooms and controlled environments. An example is the need for a controlled storage environment that does not require cleanroom standards in the same facility with an ISO class 8 cleanroom for quality control testing.
Cleanrooms can be substantial, in fact, an entire manufacturing facility can be contained within a cleanroom with factory floors covering thousands of square feet. Cleanrooms are used extensively in semiconductor manufacturing, biotechnology, medical manufacturing and other fields that are required to minimize environmental contamination.
For companies that manufacture products for both the United States and Europe, Blue Thunder Technologies will help you to understand and document the various classification systems used. Note, if you are manufacturing for shipment to Europe it is crucial – especially if you use a classification system other than the Grades A through D – to document how your classification system relates to the European classification system.
At Blue Thunder technologies, we can help you to understand what you need for your various applications. Whether you need an ISO classified cleanroom or a controlled environment, we are here to help.