Bioburden Mapping Janet Hay QC Microbiologist Tanya Davis

Bioburden Mapping Janet Hay, QC Microbiologist; Tanya Davis, Associate Statistician R&D Perrigo Company plc Abstract Problem Pharmaceutical companies are expected to perform environmental monitoring in non-sterile manufacturing facilities for quality control purposes. One of the ways Environmental Monitoring evaluates the state of facility hygiene is by performing periodic testing of the ambient air for bioburden. Bioburden is the levels of viable particles, i. e. microorganisms such as mold and bacteria, in an area. Previously, bar charts alone were used to report bioburden trends. These did not include spatial relationships. It was difficult to evaluate trends in bioburden testing and to report results in a visual way. JMP gives tools present a comprehensive view of the overall bioburden in each area. The Graph Builder and Custom Map Creator Add-In are used to make a heat map of bioburden levels. Then the dashboard can display each period’s bioburden next to the long term trend of results. The dashboard can also be sent to individuals who do not have JMP software on their computers. The viewer can click on a room and see the trend for that room highlighted. Specialized laboratory software programs exist that are able to map biological data, but JMP gives me this functionality in a program my company already uses. Method • Graph Builder • Custom Map Creator • Dashboard

Bioburden Mapping Janet Hay, QC Microbiologist; Tanya Davis, Associate Statistician R&D Perrigo Company plc

Bioburden Mapping Janet Hay, QC Microbiologist; Tanya Davis, Associate Statistician R&D Perrigo Company plc Results Conclusions The custom map creator displays results in a visual way. Trends and spatial relationships are able to be modeled along side each other. References • justin_mosiman. “Custom Map Creator. ” JMP User Community, JMP, 12 Sept. 2016, community. jmp. com/t 5/JMP-Add-Ins/Custom. Map-Creator/ta-p/21479.