Our Cleanroom Validation Service
Intech’s highly trained engineers undertake comprehensive on-site cleanroom validation services, as governed by BS EN ISO 14644 and GxP/GMP.
Working regularly in hospital operating theatres (ultra clean zone UCZ/ultra clean ventilation UCV), pharmacy aseptic and non-sterile cleanrooms, pathology labs and pharmaceutical research and production facilities, we provide:
- Operating theatre verification
- Fume cupboard service and validation
- Cabinet validation
Our services include anything ranging from air volume flow rates, HEPA filter integrity leak testing, through to microbiological air sampling and analysis.
As part of our work, we calculate:
- the air change rates for each facility, in accordance with the Orange Guide (MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015) and current ISO standards.
In the case of private and NHS hospitals, we meet:
- the requirements of HTM 03-01 Specialised Ventilation for Healthcare Premises, HBN 04-01 and HBN 13 for SSD departments.
To ensure our customers and the relevant regulatory authorities are furnished with the correct documentation, our engineers will produce clear, concise and comprehensive cleanroom validation reports, containing all the necessary information and data.
Intech staff frequently operate out of hours and during shut down periods – meaning minimal disturbance to customers.