Validate
T-SQUARED Validair is the UK’s leading expert in commissioning, qualification and validation (CQV) of clean air and contained facilities. Our validation support extends through the full lifecycle of a project, from initial scoping and consulting to ongoing maintenance and compliance.
We are trusted by leading global brands 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 involve our in-house validation experts from the earliest design stages, radically reducing timescales to a facility being operational.
The T-SQUARED validation team worked very closely with us to develop a commissioning and validation plan that was bespoke for our facility which benefitted us hugely during our subsequent MHRA Inspection. There were numerous client review meetings to ensure that all actions had been undertaken and all results were within specification. The documentation system that was developed for the project was exemplary and was fully GMP compliant.
Dr Baxter W Millar
Tried and Tested
T-SQUARED Validair’s expert team has over 30 years of experience delivering premium service in contamination control, regulatory compliance and certification services.
Our testing and validation engineers 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 us to offer UKAS ISO 17025 (Lab No.4264) accredited clean air testing services across the entire United Kingdom, Ireland and overseas.
We test and verify clean air facilities in accordance with national and international standards such as BS EN ISO 14644 Parts 1, 2, 3, 4 and 7 and BS EN 12469 as well as industry guidelines such as EU GMP Annex 1. From full cleanrooms and laboratories down to individual workstations and safety cabinets.
Contamination controlled environments
Specialised facilities working with potentially hazardous or infectious particles or fumes need regular testing and validation. We support all kinds of contamination controlled facilities, including:
- Containment Suites (CAT 1-3)
- Microbiological Safety Cabinets (Classes I, II and III)
- Negative Pressure Isolators
- Ducted Fume Cupboards
- Isolation Wards
- Gene Therapy Cleanroom Suites
And also specific equipment which requires Local Exhaust Ventilation (LEV) and compliance with CoSHH regulations and HSG258, including:
- Local Exhaust Ventilation Systems
- LEV Cabinets, Capture Hoods and Workstations
- Ducted and Recirculatory Fume Cupboards
- Safety Cabinets and Negative Pressure Isolators
To ensure Hospital Trusts meet the requirements of HTM03-01 and HBN04-01, we provide a full verification service, and compliance with NHS technical memorandum and building notes, on hospital critical ventilation systems serving:
- Conventional Operating Theatres
- Ultra-Clean Ventilation Operating Theatre Systems
- Isolation Wards
- Pharmacy & Radiopharmacy Cleanrooms
- IVF Suites
- Containment Suites (CAT 1-3)
We provide an air quality testing service for particles, oil and moisture for a variety of compressed gases, with consideration to ISPE good practice guidelines, BS EN ISO 8573 and European Pharmacopoeia.
We carry out temperature and humidity mapping validations to meet the stringent conditions of the MHRA and FDA for critical storage areas like refrigerators, freezers, cold rooms, incubators and warehousing.
Consultancy services
Industry leader Steve Ward is our in-house consultant, technical expert for ISO/TC209 Working Groups 3, 4 & 7 – keeping us on the cutting edge of compliance and regulation with in-depth knowledge of relevant regulatory authorities like the FDA and MHRA.
We support our customers with tailored consultancy packages to help guide them through GMP compliance and the complexities of validation and qualification of their facilities and equipment. We support you through every stage of a project, from initial URS preparation through all the qualification steps and into PQ. We provide support with critical validation documentation preparation, implementation, execution, gap analysis and bespoke training packages.
Support services
We provide tailored contracts for ongoing support, re-qualification, and routine monitoring and maintenance for contamination-controlled facilities and equipment. As well as equipment location solutions, decontamination, balancing and the supply and installation of critical filters for customer facilities.
End-to-End Process
Commissioning, Qualification & Validation Case Studies
1. Design
We offer our clients a full range of design services, from front end design studies through to fully integrated project designs covering all disciplines associated with a mission-critical facility.
2. Construct
Construction management is at the heart of our integrated offering. Our design and build division act as specialist contractors in the construction of critical service facilities, where a turnkey service is essential.
3. Validate
We are the UK’s leading experts in testing and validation of clean air and contamination controlled facilities and equipment. Our validation support extends through the full lifecycle of a project, from initial scoping and consulting to ongoing maintenance and compliance.
4. Maintain
We provide 360° ongoing service and maintenance for the most complex and specialised facilities to ensure you are kept operational at all times.
5. Fast Track
Our uniquely integrated ‘whole project’ approach and depth of world-class, hands-on experience reduces risk and shortens delivery timescales on even the most complex and critical projects.
