Cleanroom certification is a critical part to having a cleanroom as part of your facility. Whether you have a cleanroom for optics, electronics, medical testing or another reason, it’s important that you have the facility certified so that you are providing the level of cleanliness in the air that you think you are providing. The certifications will also help to ensure that everyone else can trust your products and results.
Levels of Cleanroom Certification
Ultimately, the cleanliness level of your cleanroom may be different than someone else’s cleanroom. Everything is based upon a number of particulates in the air. The lower the number of particles in the air, the lower the cleanliness level of the cleanroom. For example, under Federal Standard 209E, a class 1 cleanroom has 1 maximum 0.5 micron or larger particle in one cubic foot of air. When you are dealing with nanotechnology, the smallest amount of dust can ruin a product. Others that have a larger product interface may not require such a low percentage. Pharmaceutical cleanrooms are concerned about particles, but they typical can have a higher number of particles in the airstream. Pharmaceutical cleanrooms require great strides to insure the particles that are there are dead particles and not live micro-organisms.
Cleanroom certification will establish the level of the cleanroom and based on cleanliness levels, cleanroom protocols will need to be established. Employees working in the cleanroom will have to be trained as to what is required of them as they enter the facility. Some cleanrooms will require the use of a full cleanroom suit, shoe covers, and headwear. Others will simply require a smock, bouffant hat and shoe covers. The products that go into a cleanroom will also determined the cleanroom classification. Pencils and other products with natural fibers that could cause small particles to become airborne will likely be omitted from the room. A special type of cleanroom paper is used inside cleanroom envelopes. The Cleanroom classification also dictates the gowning levels inside the cleanroom, so cleanroom protocols will need to be developed based on the type of facility, products manufactured, and cleanroom level.
Testing for Cleanroom Certifications
The cleanroom certification will typically test the following points based on a test grid:
There are various tests that will go into a cleanroom certification. They will check the functions of the air lock (if applicable) to make sure that it is functioning properly. This will include the air shower if your facility has one.
There is an instrument, called a particle counter, used that will count the number of particles per cubic foot of air to determine the concentration of the airborne particles in the air. The particle counter will be used based on a test grid throughout the entire cleanroom facility. The test grid is established based on Federal Standard 209E/ ISO 14644. There are user defined points agreed to between the cleanroom owner and builder. For instance, the height of the particle counter cup is defined by contract. Typically the height is determined based on product flow height through the facility. If the product flows through the facility at 36" Above Finished Floor (typical tabletop height), then the particle counter cup should be placed a 36" AFF for testing. Some cleanrooms are certified at 6’-0" above the finished floor, but 36" is more typical.
Typically cleanrooms are certified at least once a year and are typically recertified each year thereafter. Some customer choose to have a active system of particle measuring system, so they can know how the performance of the cleanroom facility on an ongoing basis. Particle measuring systems are typically a centralized system of particle measuring locations. Each location ties into a pump that transfer air for individual points located throughout the facility back to a centralized particle counter and the particle counter will run rotate through the points to particle levels on a routine basis.
Renewal of Cleanroom Certification
The type of facility that you have will dictate how often you need cleanroom certification conducted. If you are a laboratory and are trying to get FDA approval, you may need to have your cleanroom certified on a regular basis. Otherwise, the standard operating procedure is to have the cleanroom certified annually. Once you build a cleanroom, the company who builds it for you will set up the first certification to prove the cleanroom performs as required. After that, the company that certifies the cleanroom will schedule as necessary based on your input.
Digital Air Control can perform air and water balancing, cleanroom performance testing and even certify your facility in accordance with Federal Standard 209-E or ISO 14644. Contact us for a quotation.