Assessment of microbiological monitoring for the evaluation of GMP-compliance at a department of Nuclear Medicine and Molecular Imaging of the University Medical Center Groningen

Objective: The purpose of our study was to assess trends and deviations from microbiological monitoring in De cleanroom facilities at the department of Nuclear Medicine and Molecular Imaging of the University Medical Center Groningen over the past five years. This was done to evaluate the status of GMP compliance. Methods: Data from active air sampling, passive air sampling, particle counting and contact prints from microbiological monitoring performed over the past five years were collected from our data bases. These tests are carried out routinely to comply with the applicable GMP-regulations. The data were retrospectively analyzed by counting the number of measurements and calculating the number of crossings of the set limit for each sampling location and each test. Statistical analysis was done by performing a Fisher's exact test (P 5 times decrease of limit crossings) and were statistically significant (