308 Containment/ Exposure Control for mainstream manufacturing - What can we learn from Pharma

Abstract The Pharmaceutical sector for many years have established a robust containment and exposure control regime for active pharmaceutical ingredients (APIs) to make sure employees are protected when carrying out work on processes where these APIs are present. There is guidance and processes that exist but it is very pharma centric and cannot always be applied directly to mainstream chemical manufacturing. With constant regulatory pressures and updates in occupational exposure limits (OELs) for a number of substances we are now seeing the level of containment and or exposure control required in the pharma sector in mainstream manufacturing. This is a fundamental step forwards in terms of understanding what can and cannot be done as equipment, processes and traditional views are very different to that of the pharma sector. We stand on the edge of change and this workshop will ask the question, “what can we do about making sure appropriate containment and exposure control options are in place”? These options need to be: •Identified through adequate risk assessment processes •Can exposure potential be calculated to a suitable level of confidence •How can best practices form Pharma be translated into mainstream manufacturing regarding equipment and controls •Proving compliance through suitable and accurate acceptance testing and sensible surrogate materials The scene will be set after which, however there will be ample opportunity for the audience to engage, feedback and suggest how we can develop a mainstream containment/ exposure control guide for chemical manufacturing taking the best parts of what we already know but making it relevant for largescale production.