Validation & Qualification

All clean environments must be able to demonstrate that the environment is achieving the requirements. At the completion of a project, we provide commissioning, independent validation and full documentation, to ensure that the client can comply with the requirements of regulatory authorities and meet Health and Safety standards.

A Clean Modules commissioning engineer tests and calibrates the completed air system, to ensure the clean environment is performing in accordance with the regulatory requirements. The following systems are tested and corrected during our standard commissioning service:

• Air Handling Unit
• Cooling & heating systems
• Control systems
• Room pressure regimes
• Gauging & monitoring system
• Filtration system

To ensure full independence, we provide a comprehensive independent validation service, with full traceability to national and international regulatory standards and good practices. It is our view that our clients are better served by independent validation, as opposed to validation by the provider. We have long standing arrangements with several independent validation houses to provide this service. A typical validation service might include:

• A Validation Master Plan signed off by the client
• Full physical validation
• Regulatory compliance documentation
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Independent microbiology validation
• Special clean microbiological deep clean