This part of ISO 14644 specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new and refurbished or modified cleanroom installations. It does not prescribe specific technological or contractual means of achieving these requirements. It is intended for use by users, specifiers, designers, purchasers, suppliers, builders and performance verifiers of cleanroom installations. The primary cleanliness consideration is airborne particle concentration. Detailed checklists are provided for the various stages including requirements, design, construction and start-up, which include important performance parameters to be considered.
Energy management design approaches are identified, to support an energy efficient cleanroom design. Construction guidance is provided including requirements for start-up and verification. A basic element of this standard is consideration of aspects including maintenance that will ensure continued satisfactory operation for the entire lifecycle of the cleanroom.
NOTE Further guidance in respect of the above requirements is given in annexes A to D. Normative parts 1, 2, 8, 9, 10, 12 and 17 of ISO 14644 provide complementary information. ISO 14644-7 offers guidance on design, construction and requirements for Separative Devices (clean air hoods, glove boxes, isolators and mini-environments).
The following subjects are mentioned but not addressed in this standard:
— Specific operational activities, processes to be accommodated and process equipment in the cleanroom installation
— Fire and safety regulations. The appropriate national and local regulations shall be respected and addressed during the design as appropriate.
— On-going operation, cleaning and maintenance activities, which are covered by ISO14644-5