As part of our comprehensive safety and monitoring services for the healthcare and pharmaceutical industries, Tecomak Environmental Services offer a comprehensive cleanroom validation service. This can be split into three component parts – IQ, PQ and OQ validation. Here we explain the difference between each and how we offer a high-quality, competitively-priced service which incorporates all three elements.

IQ Validation

IQ stands for Installation Qualification and is effectively a test plan which is designed to ensure that any cleanroom has the right equipment in place. This includes the heating, ventilation and air conditioning units, as well as any HEPA filters they use. Everything needs to be the correct model and make.

Other items which form part of the Installation Qualification validation include any physical materials used in its construction, including the windows, doors, ceilings and light fittings.

If the IQ assessment highlights any problems, then immediate action will need to be taken before the cleanroom can be validated.

OQ Validation

OQ stands for Operational Qualification and means that the cleanroom, and all the equipment within it, is operating to a satisfactory or required standard. ISO 14644 is the most specific of the regulations, as it applies directly to cleanrooms; The Institute of Environmental Sciences and Technology has laid down its own standards, IEST-RP-CC0063. Pharmaceutical companies in particular need to be aware of, and comply with, EU GMP (Good Manufacturing Practice) as this includes medical products.

Operational Qualification is determined by a number of tests, which include:

• Checking for leaks in HEPA filters.
• Counting the total levels of particulate particles and assessing air velocities.
• Monitoring differential pressures.
• Measuring air changes per hour within each room.
• Testing airflow visualisation.

It also means checking that all the doors, including interlocking ones, fit correctly (and provide a secure seal) and that the lights are all functioning correctly.

PQ Validation

PQ stands for Performance Qualification. It differs from OQ because it’s a collection of test cases which are used to show that the cleanroom is performing as it should under simulated ‘real-life’ conditions.

Tests are carried out in a number of areas, including:

• The levels of microorganisms in the air and on surfaces.
• Room pressurisation, including the airflow.
• Air purity, including air volume, air change rates, and the integrity of any HEPA filters being used in the cleanroom.
• The temperature and humidity (and the ability to control this over a period of time).

It is advisable to carry out a risk assessment before embarking on any PQ validation. This is not just to protect staff but also to justify which areas you pick as part of your testing process. As the initial ISO certification is performed during the PQ, it is standard practice to have the room revalidated every six months.

Cleanroom Validation from Tecomak Environmental Services

Tecomak Environmental Services will undertake all of the IQ, OQ and PQ validations as part of our cleanroom services. As well as healthcare and pharmaceutical facilities, we can also carry out this work in cleanrooms operated by the telecoms and aerospace industries.

We appreciate that time is money, so we will compile, check and issue our reports while on site. We will also split our validation teams, enabling us to work around the clock if necessary (including at times when your cleanroom wouldn’t normally be in use). We’ll always show where, when and how we collected our data. If we are unable to issue a cleanroom validation certificate, we will show where it has failed and issue advice on remedial action.

If you would like to know more about our cleanroom validation services, follow this link and fill in the online form or call us on 01732 852250.