Publication

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

Beugeling, M., Ekoume, F., Woerdenbag, H. J., Luurtsema, G., Lub-de Hooge, M. N., Touw, D. J., Rubow, S. M. & Boersma, H. H., 1-Oct-2015, In : European Journal of Nuclear Medicine and Molecular Imaging. 42, 1, p. 486 1 p.

Research output: Contribution to journalMeeting AbstractAcademic

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 <0.05, 2 sided) to assess statistically significant differences between the years. Results: For evaluation, data of 40 sampling locations were analyzed. The number of measurements carried out in 2014 complied with the number of measurements indicated in the Standard Operation Procedure 'Monitoring clean rooms NMMI', except for the contact prints. This means that, when the recent data were compared to older data, many improvements were seen in the environmental monitoring results. This is particularly demonstrated by the microbiological data for one of the grade A with the grade B background hot cells. Comparing the environmental monitoring data of 2012 and 2014, most parameters (including particle counts, settle plates and active air sampling) markedly improved (>5 times decrease of limit crossings) and were statistically significant (p
Original languageEnglish
Pages (from-to)486
Number of pages1
JournalEuropean Journal of Nuclear Medicine and Molecular Imaging
Volume42
Issue number1
Publication statusPublished - 1-Oct-2015

    Keywords

  • guanosine phosphate, nuclear medicine, monitoring, molecular imaging, university hospital, European, procedures, compliance (physical), air sampling, environmental monitoring, sampling, quality control, human, employee, skill, parameters, data base, statistical analysis, Fisher exact test

ID: 26831981