Validation Asssignment_2018 1 Designing a Clean Environment for production of Interferon alpha By Student’s Name Course + Code Class Institution Date
Validation Asssignment_2018 2 Introduction Interferons are probably the first cytokines to be discovered. During the 1950s, scientists observed various animal cells when exposed to the virus, they automatically become resistant to attack by other viruses(Hanaoka and Takeuchi, 2013). This resistance was induced by interferons secreted by virally infected cells. Interferons are produced by different cell types of which they exhibit their biological effects in various ways which include induction of cellular resistance to viral attack, regulation of growth and differentiation of various types of cells, control of the most aspects of the immune system and sustenance of early stages of pregnancy in animal species In human beings, there are about 24 genes that exist for the production of about 16 well-known interferon alphas(Hanaoka and Takeuchi, 2013). These interferons are normally classified into two classes namely class I and II where class I contain 15 interferon- alphas and type II contains only one interferon alpha(Bax et al. , 2013). A cleanroom is a controlled placement where various biotechnological and medicinal products are manufactured . All cleanrooms are not similar in terms of structure and size but apply similar standards. According to ISO 14644, the concentration of airborne particles in a controlled room is specified to certain standard limits depending on the product manufactured(ISO, 2015). Most of the contaminations in a cleanroom are generally from workers, equipment used and from the facility itself(Zhang, Sun and Ma, 2017). The purification of any drug manufactured in a cleanroom depends on the design used and monitoring processes(Whyte, Lenegan and Eaton, 2016). This study seeks to demonstrate classifications of cleanrooms, various impurities that can be present in a certain cleanroom, the design of a clean room with a complete schematic relevant to interferon –alpha and testing and monitoring required in a cleanroom evaluation.
Validation Asssignment_2018 3 Cleanrooms Classification Pharmaceutical drugs production requires special requirements in order to reduce the risks of contaminations from micro-organisms. Implementation of those regulations and standards requires personal attitude to work, training and operational experience. Sterilized medications like interferon alpha-2b must be produced in the organized cleanrooms normally referred to as clean zones(World Health Organization, 2011). The clean zones must be equipped with personnel, materials, and equipment. Due to that fact, cleanrooms must support purity levels at all standards. There should be enough air supply with necessary efficiency filters(WHO, 2016a). Cleanrooms for manufacturing of interferon alpha-2b must be classified according to the environmental requirement in order to reduce chances of product contamination. Filling, product preparation and the original materials must be done in separate cleanrooms. Every working operation need a certain purity level of environmental
- Winter '16
- Bill Oyieke
- Semiconductor device fabrication, contamination control, Cleanroom