Cleanroom validation services

UKAS ISO17025 accredited company

We work to current GMP and ISO standards

Multi-discipline service provider

Hospital theatre verification work

Intech’s highly-trained engineers undertake comprehensive on-site cleanroom validation services, as governed by BS EN ISO 14644 and GxP/GMP.

Our services include a detailed scope of testing from air volume flow rates, differential pressures and HEPA filter integrity leak testing to microbiological air sampling and analysis.

GET A QUOTE

As part of our work, we calculate the air change rates of each facility, in accordance with GMP (good manufacturing practice), the Orange Guide (MHRA rules, and Guidance for Pharmaceutical Manufacturers and Distributors 2015) and current ISO standards, including ISO14644.

In the case of private and NHS hospitals, we help clients identify compliance to 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 produce clear, concise and comprehensive cleanroom validation reports, containing all the necessary information and data.

Intech staff frequently operate out of hours and during shutdown periods – meaning minimal disturbance to our customers.

Where we work

Our customers include pharmaceutical and bio-tech R&D and manufacturing, CDMOs, healthcare/hospital facilities, including theatre suites, aseptic and non-sterile cleanrooms, pathology laboratories etc.

To compliment our cleanroom validation service, we also validate the following clean air cabinets:

Laminar flow benches
Pharmaceutical isolators
Class II microbiological safety cabinets
PCR cabinets
Weighstation enclosures
Fume cupboards
Downflow booths

This service is especially useful for clients because one vendor is looking after several disciplines, often during a single pre-arranged visit.

Pharmaceutical and bio-technology
Clean air cabinets
NHS and private hospitals

What we test

GMP Grades A, B, C and D
ISO graded cleanrooms from ISO 5 to ISO 9
DOP HEPA filter testing
Air flow velocity measurements and air change rate calculations
Differential pressure measurements
Differential pressure gauge calibration
Airborne particulate cleanliness counts (at-rest and operational)
Room recovery rate testing
Temperature, relative humidity, light and noise readings
Airflow visualisation studies
Temperature and humidity mapping of rooms and facilities
Post validation VHP decontamination of rooms and equipment

Get in touch

Intech has been a supplier to our department for over five years and in that time has constantly demonstrated their ability to competently provide a wide range of technical services. Prior to using Intech we had to deal with numerous suppliers several times throughout the year. Having a single company to contact has made the management of our various calibration and validation activities much simpler. We have saved a lot of time which has enabled us to use our limited resources on other aspects of our work.
Maintenance manager, pharmaceutical company

What we do

Calibration

Our comprehensive range of industry-leading calibration services includes an extensive list of on-site and laboratory-based instruments and equipment

Temperature Mapping

Experts in multi-point temperature mapping services, we are adept at producing fast and accurate results on equipment and facilities

Indoor air quality (IAQ) testing

Poor indoor air quality can lead to a range of health issues, and our testing services are designed to help you identify and address any IAQ concerns.

Fume cupboard servicing

We provide these services for all makes and models of fume cupboard and LEV across the UK.

LEV and validation servicing

We offer comprehensive servicing of all LEV type systems so that you comply with HSG258.

Technical resource hire

We provide skilled and experienced Calibration, Validation and CQV professionals for hire on long and short term contracts.

Staff training

We offer a range of training courses designed to equip calibration professionals with the knowledge and skills they need to excel in their roles.

Calibration administration and support

We offer calibration master list (CML) administration and support services, helping you maintain a comprehensive record of your calibration activities.