Clean Room validations

Clean Room validations

A clean room is a compatible set up in which the temperature inside the room, air borne particles, microbes, humidity levels are controlled with the use of some air-filters and some technical methodology. Clean Room validations is performed for a couple of reasons: to verify that the design matches the intended purpose, To have a check whether the complete set up is as per the user requirements specifications and the regulatory requirements. To check, if the facility created has been catering to the defined standards, to ensure that Clean Room continues to perform efficiently and it helps in the progress of business. In order to validate a clean room it becomes necessary to prove that:

1.   Sufficient quantity of air is supplied to the clean room so that the air removes the particles and/ or contamination generated in the room.
2.   The fresh air which gets pushed into the clean room is of such quality that will not add to the levels of contamination in the clean room.
3.   The movement of the air inside the room is from clean to less clean areas.
4.   The movement of air in the room shows that there are no areas in the room where the contamination is high.

There are below phases in clean room validation life cycle namely :

1.   Design qualification
2.   Installation qualification (IQ)
3.   Operation qualification (OQ)
4.   Performance qualification (PQ)
5.   Clean room certification

Out of the above, 3 major phases can be described as :

1.   Installation qualification: In this type, a check is done to ensure that all the critical installation parameters are in the required area inside the Clean Room. These include the HEPA filters, lighting parts, construction materials, HVAC units and others.


2.   Operation qualification: This phase is performed to keep a check whether the new clean room is persistently operational within the specified critical parameters. This is consistently done as per standard ISO 14644 and generally includes test checks for the HEPA filters, the count of total particles in the air, velocity of the air inside, changes in the quality of air per hour and so on.


3.   Performance qualification: This phase shows a collection of test cases used for checking that a system performs as per pre-determined fictitious real world situations. It involves testing of the levels of feasible particulate matter in the air and on floor surfaces, temperature and humidity conditions in the room. It is important for this phase that it consists of accumulating the multiple data points for both stable and changing clean room conditions to display consistency.

A proper Clean Room validations becomes increasingly important to check that products are produced in a controlled environment. It becomes equally decisive to hire an ideal team to precisely plan and coordinate all the steps to get the desired results. Our team at map filters is the best to complete all the operational activities in a regulated manner as we have quality technicians and engineers in our group who carefully plan and implement all the work related to Validation of Clean Rooms.