Cleanrooms require regular monitoring and clean room testing to ensure that contamination levels are within acceptable limits.
Governing bodies, such as the Medicines and Healthcare Products Regulatory Agency (MHRA) specify regular clean room testing, and qualification to ensure that their standards are met and maintained, but what do these tests actually involve, and what do they tell you?
Clean Room Testing – Tecomak are specialists in clean room testing to meet the requirements of all current standards and guidelines.
The Clean Room Testing Process
In order to ensure that your clean room environment is working effectively a number of factors relating to the air supply coming from your ventilation need to be tested. These tests apply to every type of clean room, whether used for the manufacture of pharmaceutical products, sterile and aseptic production, a heart valve bank, nuclear medicine and blood labelling, gene and cell therapy, assisted conception, TPN and cytotoxic work or for any other industry, and whether it uses a unidirectional or a non-unidirectional air flow system.
We will need to test the quantity of air to ensure that there is enough to dilute or remove any contamination generated within your clean room, and we will need to test the quality of the air to ensure that it is not adding to any contamination, rather than removing it.
We also need to test the flow of the air to ensure that it is moving from clean to less clean areas, minimising the movement of any contaminated air into your clean area, and also to ensure there are no areas of the room with high concentrations of pollutants.
In order to carry out these tests, for every clean room we are working in, we will measure and check:
Air supply and extract quantities – If your air supply is unidirectional we will measure and record the air velocity, while for non-unidirectional systems we will measure air supply.
Differential pressure Here we will be testing to ensure that the air in your clean room always moves from clean to less clean areas, with your clean room having a higher pressure than adjacent less clean areas.
Filter installation leak testing – Your ventilation system’s high efficiency particulate air (HEPA) filter, and its housing will be tested with DOP (Dispersed Oil Particulate) to ensure their integrity.
Containment leak testing – We will check the construction of your clean room to ensure that no airborne contamination can occur via leaks from higher pressure work areas adjacent to it.
Air movement control – Studying the movement of the air within your clean room we will check that there is sufficient air movement to dilute or remove pollutants, preventing any contamination build-up.
Room recovery – Reviewing the effectiveness of airflow we will measure how quickly a clean room recovers to its normal operating cleanliness following a release of particulate contaminant.
Airborne particles and microbial concentrations – Finally, we will carry out measurements to ensure that the concentration of particles and micro-organisms is compliant with the specification set out for your clean room.
Dependent on your clean room operations, we may also need to carry out tests on temperature, relative humidity, and the heating and cooling capabilities of the room, as well as noise, lighting and vibration levels.
Tecomak’s Clean Room Testing Services
With Tecomak you can be sure of a complete end to end service. Specialising in the testing and validation of MHRA licensed clean rooms, we offer the complete range of performance tests, including airflow volume flow measurement and air change rate calculations for non-unidirectional systems, airflow velocity measurements for unidirectional systems, HEPA filter integrity testing, room differential pressure measurement, non viable airborne particulate monitoring, airflow visualisation, recovery testing, temperature and humidity monitoring and uniformity mapping, and containment and induction leak testing.
Ensuring that you fully understand our process and your results, following any clean room testing or validation service, we will present you with clear, well structured reports that can be compiled, quality checked and issued to you while still on site, minimising the down time of your operations.
Completely flexible to your requirements and those of the standards we are testing against, your report will include a concise summary of our findings, followed by details of the acceptance criteria we have tested against and the site specific methods relating to them. As well as layout drawings indicating the location of our testing, we will issue you with test certificates, as well as calibration certificates for all of the equipment used. We will also document any recommendations for improvements that could be made.
Clean Room Testing – Tecomak are professionally qualified clean room testing engineers offering comprehensive validation services to the requirements of all current standards and guidelines.