Many people are confused about the difference between cleanroom certification and cleanroom monitoring. But their requirements and standards make them distinctly dissimilar/different.

A cleanroom is essentially a modular environment in which various factors are kept under strict control, including airborne contaminants, the temperature, relative humidity, differential pressure and static electricity. In addition, cleanrooms are evaluated based on several levels of cleanliness referred to as classes.

When a cleanroom is certified to a certain class, it must operate according to standards that meet or exceed the performance of that class under a specific occupancy status.

Certification vs. Monitoring

Cleanroom certification, essentially, involves checking the room for various parameters to ensure that it is built to a specific set of requirements. The room is also routinely retested to the same factors to ensure the standards have not changed.

On the other hand, cleanroom monitoring applies a broader approach. The monitoring of a cleanroom is done to ensure that:

• the cleanroom parameters have not changed in any way. All aspects of the construction and supporting equipment are fully operational and performing at the same level as when the room was certified,
• the process in the room is in control at all times,
• and individuals using the cleanroom always follow accepted procedures.

Cleanroom classification and class limits are established in ISO 14644-1. However, specifications for testing and monitoring to prove continued compliance are covered in ISO 14644-2. More specifically, ISO 14644-2 determines the type and frequency of testing required to conform to the standard. Some tests are mandatory; others are optional.

Compliance Demonstration

ISO 14644-2 also dictates that cleanroom particle classifications in areas cleaner than ISO class 5 require a time interval of at least six months between demonstrations of adherence to ISO 14644-1. And any areas that are less clean than ISO Class 5 require a 12-month maximum interval between displays of compliance.

In practical terms, demonstrations of compliance may be done more frequently than the maximum intervals specified in ISO 14644-2. The more often a show of compliance takes place, the smaller the loss of time and materials in the case of compliance failure. But if a cleanroom does not meet its designated standard, this can create a problematic situation. The quality of all products or processes performed in that area since the last demonstration of compliance will be suspect.

Maintaining a Constant Monitoring Plan

If an ongoing monitoring plan is developed for airborne particles and air pressure differential, changes can be made to the schedule of the particle counting certification testing. The monitoring plan should be determined by a risk assessment based on the type of facility, possible causes of contamination and impact of corruption on the product or process performed in the facility.

To make better choices about what and where particle monitoring should be performed, you should enhance your experience with different tooling and facilities, as well as your understanding of particle generation and cleanroom particle counters.

If you have additional questions or feedback on this topic, please click on the comments button below or call us at 877-688-2703