The NIST radioactivity measurement assurance program for the radiopharmaceutical industry

Cessna, Jeffrey T.; Golas, Daniel B.

doi:10.1016/j.apradiso.2012.02.110

Cited by 6 publications

(4 citation statements)

References 6 publications

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“…In November 2017, a standard NIST 5 mL flame-sealed ampoule containing 5 g of solution was obtained from the NIST Radioactivity Measurement Assurance Program (NRMAP) [22] and measured on multiple dose calibrators. The standard activity was taken from secondary standard ionization chamber (SSIC) measurements on NIST Chamber “A” (ICA) [23] using the calibration factor (“ K -value”) determined in 1976 [24].…”

Section: Resultsmentioning

confidence: 99%

An update on ‘dose calibrator’ settings for nuclides used in nuclear medicine

Bergeron

Cessna

2018

Nuclear Medicine Communications

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Section: Resultsmentioning

confidence: 99%

An update on ‘dose calibrator’ settings for nuclides used in nuclear medicine

Bergeron

Cessna

2018

Nuclear Medicine Communications

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“…Tthe Society of Nuclear Medicine (SNM) guidelines also recommend that the measurement be with 10% of the prescribed dosage. Moreover, the instruments being used are capable of accurate measurements to within 5% [79]. Therefore, programs for the establishment and dissemination of activity measurement standards in nuclear medicine are held in many countries.…”

Section: International Measurement Programmentioning

confidence: 99%

“…For over 3600 comparisons, 96% of the participants' results differed from that of NIST by less than 10%, with 98% being less than 20%. The percentage of participants results within 10% of NIST ranges from 88% to 98% [79].…”

Section: International Measurement Programmentioning

confidence: 99%

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Quality by Design and Risk Assessment for Radiopharmaceutical Manufacturing and Clinical Imaging

Liu¹,

Jian-hua²,

Men³

et al. 2012

Latest Research Into Quality Control

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IAEA), World Health Organization (WHO) and European Association of Nuclear Medicine (EANM). The attributes of the components in the quality system (QA/QC), including organization, staffing and personnel, facilities, instrumentation and equipment, operation procedure, radiopharmaceuticals, protocol and conduct of a study or a treatment, records and reports, and audit framework were further characterized. Assessments and comparisons of critical quality attributes (CQAs) for assuring accurate radioactive dosimetry calculation in the efficiency tracing of absolute activity measurement and patient-and technologistrelated risks for nuclear medicine imaging including Positron Emission Tomography (PET), Computed Tomography (CT), PET/CT, and Single Photon Emission Computed Tomography (SPECT) were identified. Quality system design based on the Requirements and Guidelines Quality policy and systemThe quality system by design for radiopharmaceuticals and clinical imaging techniques is aimed to maintain and improve the qualified service for the patients, fulfill the regulatory requirements, optimize the safety and efficacy for patient care, demonstrate a proper equipment operating condition, and obtain a reliable quantitative performance in both diagnostic and therapeutic nuclear medicine procedures [4,5]. The pursuit of excellence in quality system is not a single action over a short period, instead, it is achieved through the whole life cycle of instruments, analytical methods or education for example, from planning and procurement to decommissioning based on advanced technology [6]. Continuous quality improvement implies a commitment to continuously struggle to advance based on state-ofthe-art information and techniques developed by the nuclear medicine and metrology community at large [5].Implementation of a quality system must be in accordance with the quality police, i.e. the overall quality intentions and direction of an organization, as formally expressed by top management. And quality system includes the structure, responsibilities, and procedures for implementing quality management. An integrated infrastructure of quality policy and system design is demonstrated as in Figure 1, which is mainly developed from the European Standard EN 28402 proposed by Bergmann et al. [7]. The attributes of the components in the quality sub-system (QA/QC), e.g. organization, personnel, facilities, instrumentation, operation procedures, preparation of radiopharmaceuticals, protocol and conduct, records and reports, and audit or inspection, were further integrated and classified in this article.

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