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?
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, minimizing 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.
Quality Innovations are specialists in Clean Room Testing and all our services ensure that the ISO standards are met in order to enable you to maintain a safe environment meeting the requirements of all current standards and guidelines.
We help our customers to identify cleanroom performance issues, analyze all the possible causes and suggest the most effective solutions to overcome the problems in the shortest time span.