Once you have your cleanroom constructed, the HVAC system balanced, and the room(s) precision cleaned, your cleanroom is now ready to be certified to the classification of cleanliness it was designed to.

At this point, you have two choices: 1) you can do it in-house, or 2) hire an experienced Certification Agency.

IN-HOUSE CERTIFICATION
After purchasing the needed documents that discuss in detail the required certification tests and testing procedures in conjunction with all of the calculations needed to certify your cleanroom, you now need to obtain the proper, recently calibrated equipment to do the various tests.

You can purchase or rent the needed equipment. The equipment needed for a basic certification is:

1. capture hood or air velocity meter for air flow velocity check,
2. aerosol generator, challenging agent, and photometer for the HEPA filter integrity test,
3. pressure differential gauge for measuring room pressure differentials,
4. temperature and relative humidity meter, and
5. CFM particle counter.

Approximate costs* of above mentioned instruments:

• Purchasing the equipment is the most costly, approaching upwards of $15,000 — and you will have to get the equipment calibrated annually.
• This equipment can be rented from various places. One week’s rental can run approximately $2,600 plus shipping both ways.

Another expense is your labor to do the certification process and formulate a report that is customized to your specific application.

USING A 3RD PARTY CERTIFICATION AGENCY
While you may be up to the task of an in-house certification, there are advantages and cost savings associated with using an agency. A 3rd party certification offers:

1. experience in certifying cleanrooms,
2. familiarity of the testing equipment,
3. up-to-date and knowledgeable on current testing guidelines/practices,
4. ideas for enhancements you may have overlooked in your overall cleanroom operations,
5. skill in compiling a comprehensive, understandable report that is customized to your specific application in a timely fashion.

Obviously, there will be travel and per diem charges to come to your site. However, in the end you have a 3rd party opinion of the quality of your cleanroom facility along with a report with grid maps that you can utilize as a benchmark for establishing your on-going monitoring program.

*Equipment rental rates and purchase prices for the instruments are based upon quotes received from various rental firms and manufacturers.

Ralph Kraft is President of R. Kraft, Inc. He can be contacted at 585-621-6946; www.cleanroomservices.com.