Know what goes into the cleanroom validation process so you can best prepare and successfully validate and certify your facility.
Cleanroom control hinges on a number of complex factors. New cleanrooms are validated for a variety of reasons, including:
- Ensure the facility’s design is fit for its intended purpose
- Ensure the facility, equipment, and environment meet User Requirement Specifications (URS)
- Ensure the facility, equipment, and environment meet defined regulatory requirements
- Ensure the facility, equipment, and environment function together as a system to meet standards
Validation is accomplished through five phases. Here are the first 2:
1. Design Qualification (DQ). This phase focuses on the first bullet point above, proving the fit through objective evidence. It focuses on URS, vendor documents and specifications, facility layout, POs, design documentation, factory acceptance tests, as build drawings, and data sheets.
The output involves a phase report and Standard Documentation List (SDL) file documenting the following:
- Design requirements
- Bidding requirements
- Purchasing and order documentation
- Vendor supplied documents list
- As build drawings
- Components list
- Inspection lists
- Factory acceptance tests
Approval of the DQ phase is a pre-requisite for moving on to the next phase.
2. Installation Qualification (IQ). This phase verifies that the equipment as installed meets user and design requirements. The following is included: HVAC calibration, P&ID loop verification, HEPA filter integrity test data review, critical equipment calibration status, Site Acceptance Tests, Installation Qualification tests, piping and welding documentation, utility verification, and system SOP and work instructions.
The SDL file will address:
- Project changes
- IQ tests performed
- Supplier supplied documents
- Equipment certificate(s)
- Installation deviations
- Site Acceptance Tests
- Consumable list
- Spare part list
- Environmental review report
- List of Operational and Instructional documents
Approval of the IQ phase is a pre-requisite for moving on to the next phase.
As you can see in just the first two phases, quite a lot is involved in the validation process. It is therefore important to have an understanding of what is needed, and to plan ahead. If you need cleanroom validation, or if you have questions about it, contact Gerbig Engineering Company: 888-628-0056 or firstname.lastname@example.org.