Step 1: Familiarize yourself with 14644-4

by Richard A. Matthews

ISO 14644-4

TITLE: Cleanrooms and associated controlled environments — Part 4: Design and Construction.

SCOPE: Specifies the requirements for the design and construction of cleanroom facilities.

ISO 14644-4 covers all aspects of the design and construction of cleanrooms. At 48 pages, it's packed with information for anyone contemplating a cleanroom project.

ISO 14644-4 is a primer to intelligent cleanroom design and construction. It starts with requiring a clear definition of the roles of the primary parties involved in a cleanroom project, i.e. the customer and the supplier as well as ancillary parties such as consultants, regulatory authorities and service organizations.

The Scope of Requirements section necessitates that the purpose of the cleanroom and the operations to be carried out within it are clearly defined. The classes of air cleanliness and other environmental parameters making up the basic design must be agreed to by all the relevant parties. Other parameters such as utility needs, process support, dimensions, overall layout and entry and exit of materials and personnel must also be defined. Measurement control and monitoring parameters and the influence of external environmental factors are all part of this specification process.

The Scope of Requirements section details the assignment of tasks for the preparation, approval, execution, supervision, documentation, statement of criteria, basis of design, detailed design, construction, testing, commissioning, qualification, and the performance and witnessing of tests. More succinctly, it states who is responsible for what.

Second is the Planning and Design section, which provides an overview of the details necessary for proper cleanroom design. How does the design address the specification of requirements described above? For example, a contamination control concept should be developed for each zone of a cleanroom installation. Cost factors, timescale factors, design options, constructability of design and project flexibility are all covered in this section. It's important that the purchaser and supplier formally accept the design in accordance with predetermined acceptance criteria.

Third is the section on Construction and Start-up. Specific contamination control requirements apply to construction activities whether performed on the job site or in a remote location. A cleanroom construction protocol and clean-up procedure should be established for all locations as part of an overall quality program. Security and access control should be part of a continuous clean-up plan. Thorough cleaning is required before start-up.

After completion of construction is the critical phase of Testing and Approval of the cleanroom. This section requires that all personnel in charge of the new cleanroom be properly trained in its operation. Such training is to include cleanroom operations, maintenance and in-process control.

Testing and Approval comes in three distinct stages — construction approval (does the cleanroom comply with the design requirements?), functional approval (do all parts of the cleanroom operate together to achieve the required “as built” or “at rest” state?) and operational approval (does the cleanroom operate properly under the “operational” state?).

It is important that proper documentation be created and maintained. There is an entire Section of ISO 14644-4 devoted to suggestions for appropriate documentation. Included are “as built” drawings, test and certification data, operational and maintenance manuals, spare parts lists and training records. Such documentation is important because it provides a level of quality inherent in good cleanroom operation.

There are eight comprehensive Annex sections to ISO 14644-4, which are helpful in detailing suggested design criteria, materials of construction, approval stages, installation layout, construction procedures, environmental control requirements and air cleanliness control.

Worth noting is a 13-page generic check list in Annex H that covers 149 items to be reviewed by the customer and supplier to assure that all parties involved in a cleanroom project address all areas of concern. Specific industry and/or process items should be added to this checklist as appropriate in order that a quality cleanroom is designed and built to everyone's satisfaction. Use of this checklist provides a focus to the design and construction activity.

Prudent and intelligent management should insist that all personnel involved in the design, construction and use of cleanrooms read and be familiar with ISO 14644-4. More importantly they should utilize the checklist developed by the world-wide experts of ISO/TC209 who created this document for their use.

Richard A. Matthews is founder of Filtration Technology Inc. (Greensboro, NC) and president of Micron Video International. He is chairman of the International Organization for Standardization Technical Committee ISO/TC209 “Cleanrooms and associated clean environments,” and past president of the Institute of Environmental Sciences and Technology. He is on the CleanRooms Editorial Advisory Board.


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