URS Cleanroom

The scope of this 23 pages long document template is to help you ensure that your Cleanrooms are designed, delivered, installed, commissioned and qualified according to your requirements. It is made up of 219 individual test numbers divided into sections e.g. capacity, design and installation, material, automation, documentation, hygienic design, safety, commissioning and qualification requirements.

The document template is designed in table form with space for approval and comment for each test. It is also prepared with a field for document number and/or appendix number. ISO class 7 and ISO class 8 cleanroom forms the example in the URS template.

The scope of this “ready to use” template is to give you a tool to structure the different requirements in your User Requirement Specification (URS) and in which stage the requirement will be tested:

• Design Qualification (DQ)
• Commissioning (Factory Acceptance Test (FAT)
• Site Acceptance Test (SAT))
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Process Qualification (PQ).