Cleanroom Validation Life Cycle
Validation of a new cleanroom follows a specified lifecycle. The life cycle comprises five phases each of which accomplishes particular tasks to control variation in the modular environment.
Phase One: Design Qualification
Cleanroom validation starts with Design Qualification (DQ). The purpose of this phase is to prove through objective evidence that the design is fit for its intended purpose. Design Qualification is a verification exercise against requirements defined in the acceptance criteria of your DQ protocol.
The protocol should address the following:
• User Requirement Specifications(URS)
• Vendor documents and specifications
• Facility layout
• Purchase orders
• Design documentation
• Factory Acceptance Tests(FATs)
• As build drawings
• Data sheets
The output of the Design Qualification phase is a phase report and an Standard Documentation List (SDL) file that documents the following:
• Design requirements
• Bidding requirements
• Purchasing and order documentation
• Vendor supplied documents list
• As build drawings
• Component lists
• Inspection lists
• Factory Acceptance Tests
The approval of the Design Qualification, DQ phase is a pre-requisite for the initiation of the Installation Qualification, IQ phase.
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