Closed Systems in CNC Ballroom, A Risk Based Approach
Regulatory precedence tends to overrule scientific arguments in pharmaceutical companies’ selection of appropriate room classification for production of non-sterile API products. Regulatory authorities have for some time wanted companies to use risk assessment processes when assessing and designing pharmaceutical facilities. Many companies are still in doubt how to do this and how to act according to these evaluations. Closed systems and ballroom design have a profound impact on facility design, construction, qualification, capital and operational costs. This presentation elaborates the work of BPOG members to harmonize and define tools to evaluate appropriate room classification requirements across the biopharmaceutical industry. In this session, the audience will learn how risk based tools can be applied to gain significant cost savings designing new facilities or within their current facilities by reducing classified areas.
Lars Hovmand-Lyster, M.D. -
Principal Scientist Recovery, Diabetes Active Pharmaceutical Ingredients,
Novo Nordisk, Denmark