Cleanrooms & Regulated Facilities
Projects requiring cleanrooms and controlled environments require different technical solutions depending on both the market and regulatory authority and T-SQUARED has both the necessary resources and experience to lead such developments through the full project lifecycle from concept to completion.
From the outset of any project, a project-specific validation master plan defines clear responsibilities for all parties. Once defined, our approach offers flexibility to allow us to complement the client’s own team and lead or support at all levels.
Our approach to delivery
We work collaboratively with the client to develop the necessary performance criteria and basis of design - user requirement specification (URS). Our industry-leading design resources integrate environmental control, process utilities, process equipment integration, electrical services, environmental control systems, facility resilience, and good manufacturing practice (GMP) design and construction detailing using the latest design and CAD visualisation techniques.
Design and Construction
Our design service extends to the construction of new buildings and existing building extensions, together with associated statutory planning and building warrant applications. This design team is fully integrated into our project construction delivery team to guarantee compliance from design through construction, testing, and commissioning.
It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Written protocols can be established that specify how qualification and validation will be conducted. These protocols should specify critical steps and acceptance criteria. If required, an experienced T-SQUARED validation manager can work closely with the client’s representatives and integrate the facility and process requirements. Our involvement can extend throughout the full project lifecycle and the various qualification stages – design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and supporting the client at the final performance qualification (PQ) stage.
Upon completion, we can help clients meet their equipment and cleanroom maintenance responsibilities through planned preventative maintenance programmes offered by our T-SQUARED Facilities Services.