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| CLEAN ROOM VALIDATION |
Clean-room is a modular environment in which the important parameters such as air flow, differential pressure, relative humidity, temperature, airborne particles and microbes are kept under control. The aim of Cleaning Validation is to launch cleaning procedures & residue limits that are practical, achievable, and verifiable and insure safety. Clean rooms must be validated prior to performance. This process ensures that the clean room is functioning right. The standards that must be measured in order to validate a clean room let in: the intensity and quality of air supplied, air drift between the clean room and other rooms, air motion within the clean room and the particle counts in the clean room, including microbiological if requisite. Specific standards specify the necessities for clean room validation.
After a clean room is validated and becomes active it must regularly be checked to ensure that it extends to meet initial measures. Particular standards list the time intervals at which clean rooms should be examined and the minimum requirements a clean room must meet. These standards admit ISO 14644-2. The testing outlined in the standard ensures that the product manufactured in the room will be suit for its intended function.
CLEAN ROOM VALIDATION IS PERFORMED FOR THE FOLLOWING PURPOSES:
To ensure that the design of facility meets with its intended purpose; to ensure that the facility, equipment, and environment conforms to the User Requirement Specifications ( URS ) ; to ensure that the facility, equipment, and environment comply with the defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system meets with the defined standards.
Post validation, clean-rooms are certified to a chosen class of ISO 14644-1. Each class of ISO14544-1 has its unique requirements that must be made for a facility to be classified in the specified classification.
Precepts of Clean Room Validation/ Testing
Certain principles are used to head the validation and maintenance of clean rooms:
-Air movement in the clean room should be sufficient to guarantee that no areas within the room collect high concentrations of contamination.
-The air supply to the clean room is prime and will not add significantly to the contamination in the room.
-The air supplied to the clean room is of sufficient quantity to debase or remove contamination generated in the room.
-The air in the clean room travels from clean to less-clean areas. This downplays the unsuitable movement of contaminated air. This movement is particularly significant in relation to doorways and construction fabrics.
Clean Room Tests
There are certain tests that should be performed regularly to find out the effectiveness of the clean room. These tests include:
-Air Supply and Extract measures
For turbulently ventilated rooms, the air supply volumes should be calculated. Selection volumes should also be measured periodically. For unidirectional airflow rooms the air velocity should be evaluated.
-Pressure Differential among Areas
It is significant to confirm that all airflow in the clean room happens in the desired direction (from more clean to less clean). Measuring pressure difference between two designated areas , permits airflow direction to be determined.
-Filter Installation Leak Test
The High Efficiency Particulate Air (HEPA) filter and its housing must be determined sporadically to ensure no airborne contamination can by-pass the filter installation and enter the clean room.
-Containment Leak Test
Testing is essential to substantiate that no airborne contamination enters the clean room from neighboring higher pressure areas through leaks in the construction testing.
-Air motion Control and Recovery
The character of air movement control test needed is learned by the ventilation system in the room. Turbulently ventilated rooms need to be checked to ensure that there are no areas within the room with deficient airflow. Unidirectional airflow rooms should be determined to ensure the air velocity and direction is correct, particularly within the vital area where products are displayed to contamination.
It may also be essential to test the 'retrieval' of conventionally ventilated clean rooms from test particles or from naturally occurring particles that are introduced into the room.
-Airborne molecule and Microbial Concentrations
Once these tests have been passed the room will be evaluated for airborne particle concentration levels and, whether applicable, microbiological to insure that these levels follow with design
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