Clean rooms must be arranged and constructed so as to be appropriate for the intended work and to minimise the risk of errors. Thorough cleaning and maintenance of the rooms must be ensured. In short, any effect that could impair the product must be prevented. A logical sequence of work procedures is advisable in order to meet the requirements of the necessary cleanliness classes. To do so it is necessary to provide sufficient work surfaces and intermediate product storage surfaces.
An effective ventilation system must minimise the number of airborne particles that get into the room and must meet the requirements of the EN-ISO 14644 or GMP guidelines. Depending on the use of the clean room the number of particles or the number of germs is monitored. The temperature, ambient humidity and pressure in the room play a role in this, not least due to data comparability..
Contamination is minimised by the ventilation technology in the clean room. So-called low-turbulence displacement flow, also called laminar flow, helps in this regard. So-called laminar flow modules also can help to create low-particle areas under certain conditions.
In most clean rooms positive pressure is generated to prevent particles from penetrating.
People working in the clean room are considered the most significant source of contamination. Therefore multiple hierarchical areas are created in various clean room classes. This can minimise contamination related to changing clothes. Furthermore it is necessary to follow applicable hygiene rules for cleaning, clothing and the surfaces of the room.
Therefore the materials used in the clean room must offer abrasion-resistant surfaces; equipment and devices must not affect the flow in the room.
For manufacturing products in accordance with GMP (Good Manufacturing Practice) and GAMP (Good Automated Manufacturing Practice), it is advisable to monitor compliance with the requirements using a monitoring system, or have an automatic system do so. In the process the system documents all critical environmental, procedural and production parameters continuously and without interruption. Users can intervene if necessary.
Such systems provide the following features in an optimal way:
The qualification step demonstrates and documents the fact that the system is planned, constructed, installed and operated according to the respective rules.
The individual tests are conducted and documented in a specified procedure.
DQ: Design Qualification
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
Acceptance of all the clean room technology means verifying all requirements specified in planning and development.
In the first step of clean room qualification, the planning documents are reviewed with respect to the specifications document.
This step ensures that everything has been delivered and installed correctly and without damage.
This step documents the fact that the clean room equipment/system can be operated according to the specifications. Measurements are performed on the room in a resting state, i.e. without activities.
This means that measurements are performed on the clean room in an operational state. If the clean room technology meets all requirements, the equipment can be approved for production.
A clean room must be monitored continuously or at particular intervals, depending on the requirements. This is usually the case in pharmaceutical applications, and therefore it helps to install a monitoring system that continuously monitors the room and documents the results. Furthermore, regular maintenance and re-qualification are important.