As part of our end-to-end service, T-SQUARED can undertake validation services for both new and existing clients. Our validation engineers undergo intensive training and are equipped with state-of-the-art test instruments giving you peace of mind that our final report will comply with all the appropriate regulatory requirements.
For non-pharmaceutical projects, the validation ensures that the cleanroom or laboratory installation is providing the required cleanliness levels and that pressure regimes are as detailed in the client’s user requirements specification (URS). T-SQUARED will appoint an independent third-party to carry out the appropriate site tests with reports then being provided to the client on levels of cleanliness, filter integrity and room differential pressure levels.
For pharmaceutical projects, the validation is much more complex with DQ (design qualification), IQ (installation qualification), OQ (operational qualification) and PQ (performance qualification) requirements to be fulfilled. While the last part is the responsibility of the client, T-SQUARED will be involved from day one with the design, installation and operational qualifications in line with current good manufacturing practice to satisfy the rigorous reviews of the MHRA and FDA audits.
T-SQUARED has carried out a number of highly specialised Containment Level 3 projects for one of the most highly respected facilities in the world in accordance with ACDP (Advisory Committee for Dangerous Pathogens) regulations.Read More