97 Performance of pharmaceutical equipment – challenges during exposure monitoring

Situation When new equipment is installed in pharmaceutical industries an APCPPE test (former SMEPAC) should be performed to collect knowledge about the exposure profile of the equipment. The APCPPE test should be performed in the operational qualification phase (OQ) of the equipment. Lessons Learned In reality there are a lot of challenges to do adequate performance testing. In addition, evaluation of results and drawing conclusions is not always easy. Handpicked examples of performance testing demonstrate challenges during exposure monitoring. Challenges during evaluation are presented as well.