Pharmaceutical Industry Cleaning Services - MKP Validation

CLEAN ROOM

Cleanroom 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.

        CLEANROOM 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, cleanrooms 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.