Clean rooms play a crucial role in many industries, in particular in semi-conductor manufacturing, microelectronics, the optical industry, pharmaceuticals production, medical products and in biotechnology. These clean rooms are classified in accordance with DIN EN ISO 14644-1 and VDI 2083 Sheet 1, which define nine purity classes. These classes span ISO Class 1, which represents the highest level of purity, to ISO Class 9, which has the lowest purity level. The classification is based on the maximum permissible particle concentration per cubic meter of air. For example, an ISO Class 1 clean room may have no more than 10 particles larger than 0.1 micrometers per cubic meter of air.
In the pharmaceutical industry, the EC-GMP guidelines, especially Annex 1, are also of great importance. These guidelines set out specific requirements regarding particle limit values and the microbiological load and define four purity classes A, B, C and D. Class A offers the highest purity and is applied for sterile processes, whereas Class D has the lowest requirements and is used for less critical areas.
One further crucial aspect in the design and operation of clean rooms is the control of the air flow. Laminar flow systems, which guarantee an even flow of air with minimal turbulence, are common in higher purity classes from ISO Class 5 and better, as well as in Class A in accordance with the EC-GMP guidelines. The systems help to keep the particle concentration low and minimize the risk of contamination.
As well as particle control, the monitoring of the microbiological load is essential. Regular tests and validations are necessary to ensure that the clean rooms meet the prescribed standards. These include the inspection of air quality, surface purity and the purity of the materials and devices used.
Compliance with these norms and guidelines is crucial not only for product quality but also for the safety of the employees and of the environment. Strict controls and regular inspections help ensure that your clean rooms comply with the highest standards and that the integrity of your products is guaranteed.