EVALUATION OF CRITICAL CONSUMABLES IN CLEANROOM OF ASEPTIC AREAAbstract
Sterility is the complete absence of any viable microorganism in a drug product. The Specification of sterility is unchanging and is independent of the kind of manufacturing Process. Sterilisation of the final product in its container closure system or aseptic manufacturing is followed. Under Terminal sterilisation usually it involves filling and sealing product containers under high quality Environmental conditions. Products are filled and sealed in this type of environment, so as to minimise the microbiological content of the in-process product and also to help ensure that the Subsequent sterilisation process is successful. The main complicating factors are the temperature and humidity of the cleanroom and the variations between people. The length of time will also depend upon the grade of the cleanroom. Critical Consumables are designed to provide protection for the head, body, hands and feet. In the process of establishing a system for garment selection, it is important to consider the broader aspects of cleanroom use. The main purpose of this study is to check the level of contamination in aseptic manufacturing and to minimize it by the use of specific type of garments and Gloves in specified areas in accordance with Institute of environmental science and technology. This Article provides detailed information on how to properly gown and de-gown the Consumables in cleanroom.
G. Sunil Kumar * and M. P. Gowrav
Department of Pharmaceutics (Unit of Quality Assurance), J.S.S College of Pharmacy, Jagadguru Sri Shivarathreeswara University, Sri Shivarathreeshwara Nagar, Mysore, Karnataka, India.
12 December, 2016
07 February, 2017
17 February, 2017
01 July, 2017