| CODE | RAD5021 | ||||||
| TITLE | Operational Radiopharmacy: Towards a safe and effective approach | ||||||
| UM LEVEL | 05 - Postgraduate Modular Diploma or Degree Course | ||||||
| MQF LEVEL | 7 | ||||||
| ECTS CREDITS | 2 | ||||||
| DEPARTMENT | Radiography | ||||||
| DESCRIPTION | Sterility and aseptic procedures are considered an integral part of good radiopharmacy practices in order to produce high quality radiopharmaceuticals, following the required quality control procedures, legal and safety requirements. This study-unit is designed to provide a knowledge on the procedures of hospital radiopharmacy, aiding students to implement solutions to problems encountered during their daily clinical work in Nuclear Medicine. The study-unit focuses on teaching students the correct aseptic and sterile techniques, and radiation protection measures involved in the preparation, dispensing and usage of radiopharmaceuticals for a diverse range of clinical and therapeutic applications, after performing the required quality assurance procedures. The study-unit will also focus on informing students on GMPs (Good Manufacturing Practices). It will be offered as a stand alone CPD course. Lectures will be delivered face-to-face and may also be made available online for students via a weblink. Study-Unit Aims: This study-unit aims to facilitate students with an understanding of sterile and aseptic techniques in radiopharmacy practices, required in daily clinical practice to insure a safe and operational Radiopharmacy. Additional aims of the study-unit include : - To familiarise students with Radiopharmacy class levels/operational levels, clean dirty areas, laminar flow etc. - To gain an understanding on aseptic dressing and aseptic techniques in Radiopharmacy. - To inform students on the safe working practices used in Radiopharmacy, including procedures on receiving radioactive products, record keeping and SOP, proper storage of radioactive waste and non radioactive pharmaceutical items. - To promote discussions on the current legislation in Radiopharmacy, European Directives and GMPs, together with their application in clinical practice. - To acquire knowledge on how to perform quality control procedures and quality assurance in Radiopharmacy, including ITLC, HPLC, and Endotoxin testing in relations also to Gallium-68 and Lutetium-177 quality control measures. - To acquire knowledge on radiation protection - radiation limits, environmental monitoring, decontamination and on how to prevent cross contamination due to radiation. - To inform students on therapy radionuclides, together with radiation protection measures and handling pertaining to such radionuclides. Learning Outcomes: 1. Knowledge & Understanding: By the end of the study-unit the student will be able to: - Appraise the aseptic and sterile procedures involved in the preparation, dosage and dispensing of radiopharmaceuticals within a hospital environment. - Demonstrate the procedures of quality control and quality assurance in a hospital Radiopharmacy. - Apply the aseptic preparation of radiopharmaceuticals, together with sterility testing. - Discuss the several materials and equipment required in the radiopharmacy to ensure an aseptic and sterile environment, taking into account their applicability. - Apply all the safety and radiation protection regulations within radiopharmacy. - Apply the correct management of radioactive waste. 2. Skills: By the end of the study-unit the student will be able to: - Perform the fundamentals of preparation and stability testing of sterile radiopharmaceutical preparations. - Practice radiation protection measures while working with both diagnostic and therapeutic radionuclides. - Perform iaseptic and sterile techniques while preparing radiopharmaceuticals, handling radionuclides and preparing patient doses. - Practice the legally required quality control of radiopharmaceuticals. Main Text/s and any supplementary readings: Main Texts: - Advanced Aseptic Processing Technology, Agalloco & Akers CRC Press, 2016. - IAEA (2008), Operational Guidance on Hospital Radiopharmacy: A Safe and Effective Approach by International Atomic Energy Agency (Paperback - Oct 30, 2008). - EANM (2008), The Radiopharmacy - A Technologist Guide. Lantheus Medical Imaging. European Association of Nuclear Medicine. Supplementary Readings: - Theobald, T. (2010) Sampson's Textbook of Radiopharmacy. Pharmaceutical Press. 4th edition, Pharmaceutical Press, London. - IAEA (2016), Human Health Campus - Virtual course in Radiopharmacy. https://humanhealth.iaea.org/HHW/Radiopharmacy/VirRad/index.html |
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| STUDY-UNIT TYPE | Lecture and Independent Study | ||||||
| METHOD OF ASSESSMENT |
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| LECTURER/S | Pedro Costa Karen Borg Grima (Co-ord.) |
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The University makes every effort to ensure that the published Courses Plans, Programmes of Study and Study-Unit information are complete and up-to-date at the time of publication. The University reserves the right to make changes in case errors are detected after publication.
The availability of optional units may be subject to timetabling constraints. Units not attracting a sufficient number of registrations may be withdrawn without notice. It should be noted that all the information in the description above applies to study-units available during the academic year 2025/6. It may be subject to change in subsequent years. |
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