Aim. The mission of Nuclear Medicine should be to provide effective and time sparing performance according to validated procedures, in compliance with the regulations issued on the operator, patient protection and quality. Most of the performance diagnostic nuclear medicine involve the use of radiopharmaceuticals obtained from commercial kits available as lyophilisate which, when in use, are reconstituted with radionuclide of interest, usualy Tc-99m. High quality and safety standard allow both to avoid unnecessary patient exposure to radiation and to obtain the maximum diagnostic efficacy. The aim of this work was to find original solutions to improve quality control performance and create an operative handbook in order to uniform Nuclear Medicine staff activity and make it faster. Materials and methods. The system named “Cyclone ® Plus Storage Phosphor System” consists of a scanning laser device, an image analysis software (Image Analysis OptiQuant™) and a phosphorescence plate. At chromatography completion the Technicians read the TLC (Thin Lahier Chromatography) through the instrument. The phosphorescence plate must be exposed to the radioactive sample (TLC) and subsequently subjected to laser scanning in order to obtain the digitized images of the impression of the sample. The image is then downloaded to a computer and analyzed by the software OptiQuant ™ determining the radiochemical purity. The scanned image can be rewieued, saved and archived. Results. The technical staff involved in carrying out quality control of radiopharmaceutical identified technical solutions for the execution of the original reading of TLC, through the creation of templates of paper and automatic analysis templates corresponding to TLC to be analyzed. The operators also planned an operation flow chart that has accelerated the process of image acquisition TLC of 30% compared to manual reading. Subsequently a detailed operation handbook was drawn up, which rapresents the rule for operators and guide for new recruits training. Conclusions.The application of original solutions identified by the technical staff of the Nuclear Medicine Unit and the drafting of an easy reading operative handbook allowed an adequate staff training and a reduction in radiopharmaceutical quality control time.
Quality Control of Radiopharmaceuticals: original design for rapid determination of the purity Radiochemistry with a new Quality Control System
UCCELLI, Licia;
2012
Abstract
Aim. The mission of Nuclear Medicine should be to provide effective and time sparing performance according to validated procedures, in compliance with the regulations issued on the operator, patient protection and quality. Most of the performance diagnostic nuclear medicine involve the use of radiopharmaceuticals obtained from commercial kits available as lyophilisate which, when in use, are reconstituted with radionuclide of interest, usualy Tc-99m. High quality and safety standard allow both to avoid unnecessary patient exposure to radiation and to obtain the maximum diagnostic efficacy. The aim of this work was to find original solutions to improve quality control performance and create an operative handbook in order to uniform Nuclear Medicine staff activity and make it faster. Materials and methods. The system named “Cyclone ® Plus Storage Phosphor System” consists of a scanning laser device, an image analysis software (Image Analysis OptiQuant™) and a phosphorescence plate. At chromatography completion the Technicians read the TLC (Thin Lahier Chromatography) through the instrument. The phosphorescence plate must be exposed to the radioactive sample (TLC) and subsequently subjected to laser scanning in order to obtain the digitized images of the impression of the sample. The image is then downloaded to a computer and analyzed by the software OptiQuant ™ determining the radiochemical purity. The scanned image can be rewieued, saved and archived. Results. The technical staff involved in carrying out quality control of radiopharmaceutical identified technical solutions for the execution of the original reading of TLC, through the creation of templates of paper and automatic analysis templates corresponding to TLC to be analyzed. The operators also planned an operation flow chart that has accelerated the process of image acquisition TLC of 30% compared to manual reading. Subsequently a detailed operation handbook was drawn up, which rapresents the rule for operators and guide for new recruits training. Conclusions.The application of original solutions identified by the technical staff of the Nuclear Medicine Unit and the drafting of an easy reading operative handbook allowed an adequate staff training and a reduction in radiopharmaceutical quality control time.I documenti in SFERA sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
