Letters to the Editor

08/01/2006

Comment on May article

Just a quick comment on Karen von Holtz’s article “Preparing for cleanroom certification and validation” (CleanRooms, May 2006, p. 34) wherein she defines the Installation Qualification as “testing that proves the environment was correctly installed and that it meets the intended design specifications.” While this sounds good, it’s not quite ‘on the money.’

The Installation Qualification, or “IQ,” is an exercise wherein the total clean space is progressively inspected during construction. This inspection is then carefully documented to establish that customary clean-build workmanship and proper materials are incorporated into the structure, HVAC, electrical, plumbing, lighting, doors, pass-throughs, windows, and finishes, and that the correct equipment is properly installed to assure 100 percent compliance with design specifications (hopefully prequalified during the Design Qualification, or “DQ,” described by Ms. von Holtz as the initial “Strategy, Protocols, and Evaluation”). Little, if any, actual testing is carried out during the IQ. While the measurement or ‘pre-qual’ testing of some components may be required during the IQ to verify a structural or equipment installation dimension or specification, the IQ is more of an observation and verification process than a testing phase.

Also, “at-rest testing” is a component of the Operational Qualification, or “OQ,” and is not a part of the IQ; it is accomplished during the OQ as the (hopefully) successful result of the IQ. It’s important these qualifications, their meanings, and scope not be confused or limited. Too many construction and equipment installation mistakes are likely, even eminent, during clean space construction and equipment installation, and may only be prevented by careful, progressive audit and sign-off by qualified personnel in a comprehensive document.

-Greg F. Peters, Director, Lab Safety Corporation, Park Ridge, Illinois