Comprehensive Analysis of Environmental Monitoring Data from the Department of Nuclear Medicine and Molecular Imaging (NMMI) of the University Medical Center Groningen (UMCG)
Hendrikus H. Boersma,
Mirte M. Woerdenbag,
Sascha Mulder,
Tirza W. T. Poiesz,
Lucas B. S. Bekhof,
Hein T. Tholen,
Gert Luurtsema,
Marjolijn N. Lub-de Hooge,
Danique Giesen,
Herman J. Woerdenbag
Affiliations
Hendrikus H. Boersma
Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen (UMCG), Hanzeplein 1, 9713 GZ Groningen, The Netherlands
Mirte M. Woerdenbag
Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen (UMCG), Hanzeplein 1, 9713 GZ Groningen, The Netherlands
Sascha Mulder
Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen (UMCG), Hanzeplein 1, 9713 GZ Groningen, The Netherlands
Tirza W. T. Poiesz
Department of Pharmaceutical Technology and Biopharmacy, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands
Lucas B. S. Bekhof
Department of Pharmaceutical Technology and Biopharmacy, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands
Hein T. Tholen
Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen (UMCG), Hanzeplein 1, 9713 GZ Groningen, The Netherlands
Gert Luurtsema
Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen (UMCG), Hanzeplein 1, 9713 GZ Groningen, The Netherlands
Marjolijn N. Lub-de Hooge
Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen (UMCG), Hanzeplein 1, 9713 GZ Groningen, The Netherlands
Danique Giesen
Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Center Groningen (UMCG), Hanzeplein 1, 9713 GZ Groningen, The Netherlands
Herman J. Woerdenbag
Department of Pharmaceutical Technology and Biopharmacy, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands
Environmental monitoring (EM) is the cornerstone for the assurance of sterility during aseptic manufacturing. In this study, the EM quality aspects in the radiopharmaceutical cleanrooms of the University Medical Center Groningen (UMCG), The Netherlands, were evaluated. Hereto, data obtained from EM over the period 2010–2022 were analyzed. The data were sorted according to the Good Manufacturing Practice (GMP) classification of the respective premises with their corresponding limits, and frequencies of excursions were determined per location. The frequency of conducted measurements gradually increased between the start and end of the assessed period. There was a trend of increased action limit excursions observed between 2010–2022. We found that EM in grade A areas appeared to be significantly less compliant with GMP specifications than the combined data from all sampled premises at the facility (p < 0.00001; two-sided Fisher’s exact test). A trend was found for reduced action limit excursions for passive air sampling and particle counting, suggesting improved GMP compliance over time for this specific type of EM. The contamination recovery rate (CRR) found for cleanroom conditions, around 10%, was considered sufficient. From this comprehensive data analysis, we learn that, in order to be fully compliant with the requirements set in the recent revision of EU (European Union)-GMP Annex 1 ‘Manufacture of sterile medicinal products’ (in force as of 25 August 2023), strategies to further improve product protection are justified. For example, improved cleaning and disinfection procedures, more efficient working methods as well as optimization of the conditions under which aseptic manufacturing is performed are to be considered.
