Our Quality Management team has determined that we need to convert from a controlled environment to a cleanroom environment. Where can I find information to design and build a cleanroom?

The Institute of Environmental Science and Technology recommended practice IEST-RP-CC 012.2, “Considerations in Cleanroom Design” as well as ISO 14644-4, “Cleanrooms and associated controlled environments – Part 4: Design, Construction and Start-up” are the documents I recommend the entire team should review prior to the design and building of a cleanroom. IEST-RP-CC012.2, lists considerations for improving energy efficiency in cleanrooms with the associated concepts and actions.

This document also addresses customer questions of:

• What does the customer need to protect the product?
• Cleanroom classification?
• What type of filtration, filtration coverage, air flow, air velocity, relative humidity, light levels, room pressure, type of air return, and air handling unit?
• What are the environmental conditions required?
• What type of products and processes will be performed in the cleanroom?
• What type of system is designed?
• Will it be energy efficient?
• Can one build for future using current technology?
• What is value engineering?
• What is process isolation control?
• Noise control. Sound level.
• Positive plenum versus negative plenum.

Additionally the construction of the cleanroom must be a team effort with the design of the building and related utilities infrastructure such as:

• boilers for heat and humidifiers,
• chillers for de-humidification,
• WFI and/or RO/DI water for process,
• electrical power,
• integrity of roof system,
• mechanical design matches facility design.

Currently there is a surplus of existing buildings that may reduce the overall cost of construction of the cleanroom and the sky is the limit for upgrades so plan for the future expansion of your product and process.

Other practical tips recommended are:

• Budget money for continuous cleaning of the work site to protect the integrity of the cleanroom from excessive contamination.
• Maintain constant diligence for non-outgassing, nonparticulating materials used by subcontractors.
• There are many single source suppliers of cleanroom materials and products but don’t count on them to know your unique specifications.
• Always discriminate on skill trades’ abilities, efficiency, and capabilities.
• Competent mechanical contractors are critical to the integration of the cleanroom with the facility infrastructure.
• Constant site supervision by the Project Engineer is critical.
• Plan for change orders no matter how diligent your team was during the design phase.
• All the reading and research is a good foundation of knowledge but there is nothing like actually doing it so look for experienced cleanroom contractors and subcontractors.
• “The devil is in the details.” All details must be checked and rechecked every day.

The ISO 14644-4 document addresses the requirement to validate the cleanroom and its associated equipment. A Master Validation plan is written and provides a template for the Installation Qualification, Operational Qualification, and Performance Qualification processes. In addition to standard operation procedures for daily production activities, operation and calibration of equipment; standard operating procedures for facilities maintenance; energy management and utilities; security; space planning; emergency response; and crisis management should be considered.

I thank Gregg Remer, Senior Engineer, Cintas Corporation and John VanderWall, Midwest Cleanroom Associates for their recommendations for this column.

Jan Eudy is an IEST Past-President. She is also Corporate Q.A. Manager for Cintas Cleanroom Resources.

From: “Ask Jan: Facility Considerations”