TY - STD TI - Aerts J, Ballinger JR, Behe M, Decristoforo C, Elsinga PH, Faivre-Chauvet A, et al. Guidance on current good radiopharmacy practice for the small-scale preparation of radiopharmaceuticals using automated modules: a European perspective. J Label Compd Radiopharm. 2014;57:615–20. https://doi.org/10.1002/jlcr.3227SMASH. ID - ref1 ER - TY - STD TI - Covens P, Berus D, Vanhavere F, Caveliers V. The introduction of automated dispensing and injection during PET procedures: a step in the optimisation of extremity doses and whole-body doses of nuclear medicine staff. Radiat Prot Dosim. 2010;140:250–8. https://doi.org/10.1093/rpd/ncq110SMASH. ID - ref2 ER - TY - STD TI - Decristoforo C, Patt M. Are we “preparing” radiopharmaceuticals? EJNMMI Radiopharm Chem. 2016;1:12. https://doi.org/10.1186/s41181-016-0011-7SMASH. ID - ref3 ER - TY - STD TI - EudraLex. Volume 4 - Good Manufacturing Practice (GMP) guidelines - European Commission. 2015. https://ec.europa.eu/health/documents/eudralex/vol-4_fr. Accessed 27 Dec 2018. UR - https://ec.europa.eu/health/documents/eudralex/vol-4_fr ID - ref4 ER - TY - STD TI - Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography (PET) Drugs. Food and Drug Administration CDER CGMP. 2016. http://academy.gmp-compliance.org/guidemgr/files/UCM273766.PDF. Accessed 27 Dec 18. UR - http://academy.gmp-compliance.org/guidemgr/files/UCM273766.PDF ID - ref5 ER - TY - STD TI - ISO 14644-1:2017(en), Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration. 2017. https://www.iso.org/obp/ui/#iso:std:iso:14644:-1:ed-2:v1:en. Accessed 27 Dec 2018. UR - https://www.iso.org/obp/ui/#iso:std:iso:14644:-1:ed-2:v1:en ID - ref6 ER - TY - STD TI - Lecchi M, Lucignani G, Maioli C, Ignelzi G, Del Sole A. Validation of a new protocol for 18F-FDG infusion using an automatic combined dispenser and injector system. Eur J Nucl Med Mol Imaging. 2012;39:1720–9. https://doi.org/10.1007/s00259-012-2174-0SMASH. ID - ref7 ER - TY - STD TI - O’Doherty J, Woods E, Modde L, Mackewn J. Validation of an automated dose-dispensing system for 18F-FDG administrations and associated reduction in operator extremity dose. Nucl Med Commun. 2014;35:151–9. https://doi.org/10.1097/MNM.0000000000000027SMASH. ID - ref8 ER - TY - STD TI - PIC/S (n.d.)“Recommendations on Validation Master Plan, Installation and Operational Qualification, Non-sterile Process Validation, Cleaning Validation” https://www.picscheme.org/layout/document.php?id=152. Accessed 27 Dec 18. UR - https://www.picscheme.org/layout/document.php?id=152 ID - ref9 ER - TY - STD TI - Todde S, Peitl PK, Elsinga P, Koziorowski J, Ferrari V, Ocak EM, et al. Guidance on validation and qualification of processes and operations involving radiopharmaceuticals. EJNMMI Radiopharm Chem. 2017;2:8. https://doi.org/10.1186/s41181-017-0025-9SMASH. ID - ref10 ER -