How does AM Technical Solutions handle equipment calibration?

All test instruments are calibrated annually or according to manufacturer’s specifications. All applicable calibration certificates are included with the test reports.

What is NEBB?

Established in 1971, the National Environmental Balancing Bureau (NEBB) is the premier international certification association for firms that perform testing, adjusting and balancing (TAB) of heating, ventilating and air-conditioning systems in addition to building systems commissioning, sound and vibration measurement, retro-commissioning, fume hood testing and cleanroom performance certification.

Is there an advantage to using NEBB certified firm?

Yes. NEBB certification is tangible proof that a company and its supervisors are qualified in the proper methods and procedures for performance testing of cleanrooms and/or cleanspaces.

What is it that you are actually certifying?

Cleanroom certification means that a cleanroom or clean zone meets the requirements of Fed. Std. 209E, ISO 14644-1, or both.

What is the difference between Fed Std. 209E and ISO 14644?

The Fed. Std. 209E was a USA standard that was sunset in Nov.29, 2001, and replaced by ISO 14644-1, the International standard. Even though 209E has been sunset it is still used by many companies that feel it is a stricter standard.

How often should we be certified?

Certification should be performed according to the GMP (Good Manufacturing Practices) or specification used by your company. ISO 14644-2 requires Class 1 through 5 to be certified every 6 months, and Class 6 through 9 to be certified every 12 months.

We are a FDA regulated facility. What should we be doing to pass an FDA audit?

Develop a GMP specification and follow it. Your procedure should include testing your cleanroom’s particle counts, airflow, and room pressure. If you are unable to handle these tests yourself, you can have them performed by a NEBB certified company like AM Technical Solutions.