Classification, testing and delivery need to align.
The ISO 14644 family provides the central framework for cleanroom classification, test methods and the design, construction and start-up process. The target class, occupancy state, acceptance criteria and test plan should be agreed for each project.
- ✓Target classification and occupancy state
- ✓Particle concentration and performance testing
- ✓Design, construction and start-up requirements
- ✓Monitoring and requalification strategy
Sterile manufacture needs a wider control strategy.
For medicinal products, cleanroom grades sit within broader Good Manufacturing Practice expectations. Facility design should support contamination control, personnel and material flow, cleaning, monitoring, qualification and reliable operation.
- ✓Applicable UK and EU GMP expectations
- ✓Contamination Control Strategy inputs
- ✓Aseptic and sterile processing needs
- ✓Qualification and handover documentation
Healthcare ventilation must suit the clinical application.
Healthcare cleanrooms and specialist clinical environments may need to consider HTM 03-01, local policies and application-specific guidance alongside cleanroom classification principles.
- ✓Specialised healthcare ventilation
- ✓Hospital pharmacy environments
- ✓Pressure and containment strategy
- ✓Acceptance testing and maintainability
Installation carries legal and practical duties.
Cleanroom construction is subject to the same health and safety duties as other construction work. Contractors should demonstrate the skills, knowledge, training and experience required for their role, with suitable planning, coordination and risk control.
- ✓CDM dutyholder arrangements
- ✓Competent designers and contractors
- ✓SSIP or equivalent safety evidence where relevant
- ✓Insurance, RAMS and project-specific controls
Qualifications must match the services involved.
Where refrigeration, air-conditioning or heat-pump systems containing fluorinated gases are installed or serviced, the appropriate individual qualifications and company certification are legal requirements.
- ✓Applicable F-Gas qualifications
- ✓Certified company arrangements
- ✓Commissioning and service records
- ✓Safe recovery and lifecycle responsibilities
Good suppliers can evidence how they operate.
Depending on the project and buyer requirements, relevant evidence may include certified quality, environmental and occupational health and safety management systems. These support due diligence but do not replace cleanroom-specific technical capability.
- ✓ISO 9001 quality management
- ✓ISO 14001 environmental management
- ✓ISO 45001 occupational health and safety
- ✓Project references and accountable delivery