Cleanroom Certification and Management

Cleanroom Certification and Management

There are several industries that require controlled environments for their work. These environments, referred to as clean rooms, not only ensure that the business is producing quality work but also that the environment is compliant with federal regulations. Depending on the industry and the work that is being done in the room, a particular clean room classification may need to be achieved. There are companies available to help construct and manage these controlled environments.
The Certification Process


When a business is building a clean room, the room needs to be certified to make sure it meets certain requirements. The FDA requires controlled environments for certain industries, including biotechnology and pharmaceutical. Some of the requirements include specific temperature, humidity and pressure levels. When the room is being constructed, there are specialist companies that can come in and oversee the process. These experts can then test and certify the clean room, giving the business owner confidence that the rigorous and important standards have been met. The certification of the room can also be done periodically depending on the needs of each business. After the room has been certified the appropriate documentation of the clean room classification will be produced.

Management of a Clean Room

Between certification inspections, the room does need to be monitored to ensure there is not a breach in the environment. Monitoring the temperature and humidity level of the room is one way to manage the room. Some other services that could be used are testing for airborne and surface bacteria and testing for airborne articulate. If the business uses chemical hoods, it might be a good idea to have them tested periodically. Making sure that these are performing correctly and the room is properly ventilated will keep the room safe and free from unnecessary particles. Periodic testing and monitoring will keep the environment up to standard and ensure that it passes certification at the necessary times.

If the room is ever not up to standard, experts will problem solve to find a solution as quickly as possible. A good clean room manager will be highly trained, work with the business owner to identify concerns and issues and keep the owner updated with progress that is made on resolving the issue.

Clean Room Products

Since these environments are very controlled and organized, only certain things can be taken into them. When working in the room, certain clothing could be required to ensure that bacteria or other contaminant are not brought into the room. The clothing could be sterile or non-sterile, but disposable. The clean rooms also need to be cleaned themselves. An everyday household cleaner may not be strong enough to do the job. Using special cleaning agents could be required to make sure that the clean room classification is maintained.

When constructing a clean room, there are important federal regulations that must be followed and met. Hiring an expert company to ensure that the room has met the appropriate clean room classification and remains at that standard can give the business owner confidence that the controlled environment exceeds expectations.