Commissioning, Qualification & Validation
Specialist regulatory compliance, testing and validation services for the most complex and controlled clean air environments. T-SQUARED Validair’s expert team has over 35 years of experience delivering premium service in contamination control, regulatory compliance and certification services.
We provide premium commissioning, qualification and validation (CQV), plus consultancy and support services for all kinds of controlled and cleanroom environments. We do this as part of our turnkey project delivery, but also as an independent service for any controlled facility.
T-SQUARED is trusted by global leaders like Pfizer, GSK and Oxford Biomedica to design compliant and fully functional facilities, and to keep those specialised spaces ahead of evolving regulatory and legal frameworks.
We reduce risk by designing-in regulatory compliance from day one of any project. We always involve our in-house validation experts from the earliest design stages. This can radically reduce timescales to a facility being operational.
Our expert teams are experienced in every type of clean air application, from a single cabinet to the largest ISO Class 4 cleanroom in Europe.
Our in-house network of qualified field services engineers enables T-SQUARED Validair to offer UKAS ISO 17025 (Lab No.4264) accredited clean air testing services across the entire United Kingdom, Ireland and overseas.
Industry leader Steve Ward is our in-house consultant, technical expert for ISO/TC209 Working Groups and chair of LBI/30 BSI Cleanroom Technology Committee – keeping us on the cutting edge of standards and regulatory compliance.
T-SQUARED benefits from in-depth knowledge of relevant regulatory authorities’ expectations like the FDA and MHRA.
We set out to be the quality choice because our quality is the best. The evidence is in our ISO 9001 accreditation and ISO 17025 UKAS certification as well as our ethos to meet and exceed customer expectations. But more than that, we always do what we came to do. That is a vital part of delivering the very best quality service.
Steve Ward
Ongoing on-site support
Testing and validation is never a once-and-done process. Compliance is a continuous process and through their entire lifecycle, critical facilities need to be regularly re-tested. T-SQUARED Validair provides tailored proactive contracts for ongoing support, re-qualification, monitoring and maintenance for all contamination-controlled facilities and equipment.
Our on-site support services include equipment location solutions, decontamination, balancing and the supply and installation of critical filters for your facilities.
We offer a full range of remedial and Planned Preventative Maintenance (PPM) support services for contamination-controlled facilities and equipment. We also provide a comprehensive commissioning package for the pre-commissioning, setting to work and balancing of air systems.
And as part of our full-service commitment to our customers, we offer a rapid and efficient decontamination service. We deploy specialist equipment that utilises chlorine dioxide dry gas technology to swiftly decontaminate facilities and all equipment contained within them.
Expertise you can call on
GMP compliance, validation and qualification of your facilities can be a complex and daunting process. T-SQUARED Validair’s experts can support you through a tailored consultancy package, providing a structure to conclusively demonstrate compliance.
Our industry-leading teams provide expert support with critical validation documentation preparation, implementation and execution. We can be with you at every stage of a project, from initial URS preparation through all the qualification steps and into PQ. Our gap analysis studies and audit investigations pinpoint and address any shortfalls that may exist in your existing systems or procedures.
- User Requirement Specifications (URS)
- Validation Master Plans (VMP)
- Contamination Control Strategies (CCS)
- Tender Proposal Evaluations
- Enhanced Design Reviews – Design Qualification (DQ)
- Factory Acceptance Tests (FAT)
- Site Acceptance Tests (SAT)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Validation Summary Reports (VSR)
Compliance and emergency training
T-SQUARED Validair’s consultancy service can also offer bespoke training packages on basic contamination control, cleanroom design and construction, current and proposed cleanroom standards, cleanroom changing procedures and engineering support for clean areas.
T-SQUARED Validair’s In House Cleanroom R&D and Training Facility
Our in-house training facility meets exacting requirements for research and fault-finding and is also used by our field service team as a hands-on training resource.
Various operating parameters of the cleanroom’s control system can be set to underperform, which will make the room fail. That allows the field service teams to experience challenging real-life situations by replicating failing cleanrooms to develop strategies that resolve the critical issues most often encountered.
The bespoke demonstration cleanroom is flexible in its performance and functionality, allowing the T-SQUARED Validair team to push the boundaries of experimentation, testing and training processes.
End-To-End Process
Commissioning, Qualification & Validation Case Studies
Commissioning, Qualification & Validation News & Insights
Specialist & Controlled Facilities
We make uniquely specialised spaces, where some of the world’s smartest people do critical, often life-saving, work. We also create state-of-the art buildings and controlled environments for research, manufacturing, and specialised storage.
Life Sciences
We are the UK’s foremost experts in creating tightly controlled, hard-working spaces for the demanding life sciences sector. From biotechnology and vaccine research to high-volume drug manufacturing and medical devices, we understand the challenges.
Quantum & Electronics
Micro-electronics and the emerging quantum industry demand incredibly high levels of accuracy and performance. The tightly-controlled working environments we deliver are essential, across research, manufacturing and testing facilities.
Advanced Manufacturing
Complex manufacturing industries require precise environmental control. Whether it’s pharmaceuticals, medical devices, electronics, battery tech, aerospace, or even satellites, each industry has specific challenges than need our experience and expertise.
Space Industry
We deliver highly specialised working environments for research, manufacturing and testing facilities in the fast-growing space industry. From satellite assembly cleanrooms to extreme environment component testing.
