Clean Room Validation how it’s done different requirements of clean Room Validation from particle Count to Microbial Count Limits methods to do it?
Validation is an important activity in Pharmaceutical Industry, it impart trust on the process and inturn the product manufactured.
For doing validation of clean room, unless all the installed equipment are validated, the Clean Room validation activity In an clean room don’t get complete.
Validation activity of a Clean Room requires to do are as follows.
1.Proper fitment of filters, check if there is any leakage of air from the joint of filters.
2. Filter integrity test, to verify if there is any damage inside the HEPA filter.
3. Air velocity test.
4. Airflow patern test. Air flow visualisation.
5. Particle count at Rest and at working condition
6. Viable microbial count in clean room at working as well as rest condition.
Before proceeding for above tests for validation of clean room the of the equipments installed in the clean Room are required to be validated.
For example a clean room in a sterile pharmaceuticals manufacturing, requires Isolators and other barrier technology equipments RABS. These equipment have different set of requirements, like laminar air flow and air pressure, gloves integrity ect. These equipment must be validated by the set of test recommend for them.
Fliter Fitment: There should not be any leakage of air from sealing points, so that unfiltered air is blown inside the clean room without filtering.
Filter integrity test: PAO aerosol test, the aerosol of fine particles of poly alpha olyphine is put inside the filter and verified is the filter media capable of filtering out abou 99.997% of the aerosol particles.
Air flow pattern study: This is important since it gives idea if the all air is filtered or not and is the air flow capable of preventing cross contamination. It give idea about air flows is the air flow in the direction as planned from the area designed to be higher pressure to area designed as low pressure, and the air is again taken back from return air points in clean room.
FDA guidelines Europian Unions Guidelines mention that videography of the Air flow pattern should be done by making use of smoke, making use of dry ice smoke or sutable smoke generator.
Air Velocity: Air velocity is measured at different points from the supply air filter, at different positions, anemometer is kept at corners and at central position on the filter.
Why Air velocity is measured:
By measuring air velocity, we come to know how fast the air in the clean Room is filtered and made particle free. More is the air velocity, more will be the CFM, more will be the Air Changes per hour and air inside the room will be more cleaner.
What is CFM : CFM is the measure of amount of air propelled in to the clean room per minute the amout of air is measured as cubic feet, therefore CFM means cubic feet per minute. CFM depend on the speed of the blower in the Air handling unit.