Validation
Where validation is a requirement, our testing and validation team will prepare the protocols, working closely with the project team and our supply chain to ensure clear information and efficient execution.
Validation requirements will be determined and carried out in accordance with FDA regulations and Guidelines and cGMP.
Working within highly regulated industries we have developed procedures and documentation to support the rigorous validation processes which often apply. Our validation engineers can write and execute DQ, IQ and OQ protocols associated with the HVAC, specialist water systems and the cleanroom construction itself. We have the capability to take on the lead role in the validation process or we can provide a supporting role to the Client’s validation team where required.
Our validation contracts consist of the following services :-
- HEPA Filter Testing
- Pressure Differential Tests
- Air Velocity & Uniformity Tests
- Air Volumes & Air Change Tests
- Containment Leak Tests
- Airborne Particulate Counts
- Clean-up & Recovery Tests
- Airflow Visualisation and Smoke Tests
We also offer Validation Contracts for 12 to 36 months to help clients budget and plan for operational efficiency.
