Intech carries out on-site Cleanroom Validation including HEPA Filter Testing in accordance with British Standard BS EN ISO 14644 Part 3. 
We also carry out work in NHS Hospitals to meet the requirements of HTM03-01 Specialised Ventiliation for Healthcare Premises and HBN13 for SSD departments. We also service and validate Ultra Clean Zone (UCV) Surgical canopies, including the supply, fitment and testing of pre and HEPA Filters.
Our engineers are fully trained in cleanroom practice and have a sound understanding of the requirements of GxP/GMP. We work regularly in Hospitals, Laboratories and Pharmaceutical research and production facilities. Although we focus on the Pharmaceutical & Healthcare industries, we are by no means limited to it.
We offer extremely competitive rates and regularly work out of hours, at weekends and during shut down periods so as to provide a minimal disturbance service to customers.
Cleanroom Validation Services Include the following tests:
- HEPA Filter Integrity Leak Testing – DOP Method
- Air Volume Flow Rates
- Air Change Rate Calculations (ACR)
- Airborne Particulate Cleanliness Counts
- Differential Pressure Measurements
- Differential Pressure Gauge Calibration
- Temperature, Humidity, Light and Noise Level readings
- Recovery performance testing
- Magnehelic pressure gauge calibration
- Airflow visualisation tests, supported by dvd and written report
- Airflow Balancing
HEPA Filters are carefully tested using the industry standard DOP method, whereby each filter is subjected to an upstream aerosol challenge, the downstream side of the filter is scanned with a photometer to identify the presence of any leaks. It is also important to ensure that each filter has been sited correctly and so the filter frame and its housing are also thoroughly checked. Where failures have been identified we are able to specify and source replacement filters for customers, often at very favourable rates.
We calculate the Air Change Rates for each facility, in accordance with the Orange Guide (MHRA Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007) and current ISO standards. In the event of contamination it is important for customers to know that the air will be changed in accordance with site and regulatory requirements. Our clear and concise reports help customers and auditors quickly identify the performance of their facility in this respect.
Airborne Particulate Cleanliness Counts are performed in accordance with each clients facility classification, whether it be GMP or ISO. We use state of the art Particle Counters that are regularly serviced and calibrated to ensure optimum performance and confidence in results.
Room Differential Pressure Measurements are recorded on calibrated micro-manometers to ensure that the pressure regime / cascade requirements of each facility are maintained.
We use calibrated instrumentation to record the light, sound, temperature and humidity levels at locations as agreed with the client.
Our HEPA filter testing services are performed in the following:
- HEPA Filter testing in Air Handling Units (AHU’s)
- HEPA Filter Testing in changing rooms
- HEPA Filter Testing in cleanrooms
- HEPA Filter Testing in safety cabinets
- HEPA Filter Testing in fume cupboards
- HEPA Filter Testing in laminar flow cupboards
- HEPA Filter Testing in Pharmaceutical Isolators
Energy Conservation Audits
Energy conservation audits can be performed to assess the efficiency of clean air systems and look for improvements in the operation
of (for example) AHU units.