Design installation and Validation of Clean Room Facility

Abstract

Clean room is one of the facilities deployed in the Pharmaceutical industry, Electronics industry, Food processing industry, Chemical / Biological laboratories, etc., in which the indoor air quality and air quantity are stringently controlled. Indoor air quality is mainly controlled by eliminating airborne particles, maintaining temperature and relative humidity suitable for given application. Apart from this controlled air flow pattern is one of the important parameters to be considered. Clean room is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the room to provide appropriate Indoor environment for a particular process. This type of desirable environment is necessary for the manufacturing of highly delicate products such as Semiconductor, Aerospace, Aseptic food products and test laboratories widely used in Pharmaceutical industries. Clean room can be classified into several groups based on Standards employed such as ISO, Federal standard 209, European standards, British Standards, etc. There are many designing parameters like particle concentration rate, Filtration level, Surface cleanliness and design of air change rate. Each parameter must be precisely maintained to meet desirable particle concentration and required Indoor environment. In this report design methodology for clean room class 7, as per ISO (Organization for International Standards) 14644 - 1 to 8, have been given. Also guideline provided in United States Food and Drug Authority (US-FDA) and Good Manufacturing Practices (GMP), for maintenance of Indoor air quality within the clean room, have been discussed. Also different energy reduction techniques have been proposed and different design parameters like, air change rate, particle concentration, filter leakage, pressure difference, air flow pattern, recovery time have been tested and validated with the design.