Cyclotron & Radiopharmaceuticals
About
Cyclotron and Radiopharmaceuticals Department (C&RD) is a state-of-the art facility for two primary activities: Radiopharmaceuticals manufacturing, and Radioisotope research. Radiopharmaceuticals manufacturing program is not only quite unique even for a major medical center, but also an essential component of KFSH&RC in providing the specialty services and quality patient care for the population of the Kingdom. On-demand and reliable availability of radiopharmaceuticals are essential components of viable nuclear medicine practice. C&RD manufactures a wide range of radiopharmaceuticals used in diagnostic medical imaging, as well as for radiotherapy. Products are manufactured according to the international and Saudi Food and Drug Authority (SFDA) standards of Good Manufacturing Practices (GMP), as well as in adherence to the ISO 9001 Quality Management System (QMS). The high-quality products are supplied to some 50 nuclear medicine centers throughout the Kingdom.
Radiopharmaceuticals manufactured at the C&RD facility are characterized by the relatively short to ultra-short half-life of the radioisotope contained within. Therefore, the optimum utilization of these radiopharmaceuticals necessitates on-site availability of a particle accelerator (cyclotron) which can transform non-radioactive atoms into radioactive atoms. At the C&RD facility, three cyclotrons are currently dedicated to producing several essential radioisotopes, which are transformed into radiopharmaceuticals, and subsequently qualified as suitable for human use through rigorous testing and quality assurance.
Research activities of the C&RD are focused on developing new radioisotopes and radioactive molecular probes with potential usefulness in molecular imaging and therapy. The facility comprises of appropriate equipment, including a micro-PET/CT for in vivo studies of the new radiotracers for achieving translational research from bench to the bed-side.
C&RD's multi-disciplinary staff is a blend of engineers, chemists, radiochemists, radiopharmacists, and quality control chemists all working toward KFSH&RC's goal of providing the specialty services in patient care. The Department is committed to the policy of Quality in Performance and Pride in Achievement.
Research Activities
The mission of C&RD is to provide diagnostic and therapeutic radiopharmaceutical products that are manufactured by employing the highest quality standards, and to make the Kingdom of Saudi Arabia self-sufficient in all its radiopharmaceutical requirements.
The multi-disciplinary composition of C&RD mandates all sections of the Department to have well defined goals and objectives that are collectively aimed at achieving the missions of not only the Department but also those of the Research Centre and the Hospital. These include:
- Manufacturing diagnostic medical imaging products (radiopharmaceuticals) in compliance with the national and international standards of quality, purity, efficacy and safety.
- Developing protocols and procedures for on time, every time supply of products to the customers.
- Maintaining a comprehensive QMS (GMP and ISO 9001) for maximum quality and quality assurance in the radiopharmaceuticals.
- Upgrading technologies and resources for achieving comprehensiveness in radiopharmaceuticals manufacturing.
- Nurturing a stimulating work environment and providing opportunities to all staff for continued professional development, education, and training.
- Developing staff with maximum number of Saudi national along with good mix of experience and expertise from abroad.
- Engaging in collaborations with scientists within the Research Centre, KFSH&RC and external institutions in developing collaborative research projects, staff development and technology transfers.
- Developing efficient and reliable methods for radioisotope production, and developing methods for radiolabelling biomolecules.
The unique program has produced the first radiopharmaceutical batch in 1983 has progressed steadily for over 30 years to the current capability of manufacturing several radioisotopes which are transformed into a wide range of radiopharmaceutical products. The high quality of products is substantiated from customer satisfaction and the record of diminutive untoward reaction to the patient.
Continued commitment of providing the specialty services to patients, KFSH&RC has completed the new expansion of C&RD facility to house three cyclotrons, a Tc-99m generators manufacturing facility and a “Cold Kits” manufacturing facility to provide over 95% of the all radiopharmaceutical needs in the Kingdom with surplus capacity for export to neighboring countries.
Sections
- Cyclotron Operations
The cyclotron is the first link and the key factor in the radiopharmaceutical production chain. Consequently, reliability and efficient operation is of paramount importance. This section has the responsibility to ensure that the currently available three cyclotrons (CS-30 with proton energy of 26.7 MeV, RDS Eclipse with proton energy of 11 MeV and IBA Cyclone 30 with proton energy of 30 MeV) are fully functional to increase not only the reliability, but also the capability for manufacturing variety of isotopes. Plans are being developed for the staff to refurbish the 33 year old CS-30 cyclotron in readiness for large volume production of radioisotopes.
The Cyclotron Section staff (basically engineers) has the experience and expertise to diagnose and troubleshoot problems with vacuum, electronic and electromechanical systems. A well-furnished precision machine shop with advanced equipment and facilities for fabricating parts and components supports the maximum up-time of the accelerators, and participates in development activities of not only the Department, but also the Research Centre and the Hospital.
- Radiopharmaceutical Production (RPP)
Fundamental constituents of diagnostic imaging and radiotherapy are the radioactive atoms that are formulated into useful radiopharmaceuticals. RPP Section is responsible for manufacturing these radiopharmaceuticals, not only on time, every time, but also in compliance with the protocols of GMP and ISO 9000 QMS. Manufacturing of sterile injectable products is performed in controlled environment of clean rooms according to the international standards of the Good Manufacturing Practices (GMP) and Good Radiopharmacy Practices (GRP). C&RD is the biggest source of radiopharmaceutical products in the region, extending its services to most hospitals in the Kingdom and in some neighboring countries. This allows medical practitioners easy access to short-life radiopharmaceuticals which would otherwise have to be imported at greater cost and inconvenience. Furthermore, the Radiopharmaceuticals Production staff’s activities are geared to introducing 'new' radiopharmaceuticals as required by the clinicians and researchers. The reliability of distribution is the utmost important aspect of short-lived radiopharmaceuticals manufacturing; the RPP Section meets this goal quite reliably.
- Quality Control and Quality Assurance (QC/QA)
Management of quality in products manufactured in our facility is of paramount importance. This operational philosophy is reflected in the establishment of our QMS derived from the national and international guidelines of GMP and the ISO 9001 Quality Standard.
Our QMS employs a process-based approach for all its operations to provide the assurance that all processes are fully validated and are strictly controlled. These processes and procedures (SOPs) are periodically assessed for continued suitability. The end result is the extraordinary success rate of achieving consistent high quality.
Periodic Internal and External Audits are carried out to ensure the effective implementation of the QMS. Because of our customer-focused approach, we are always striving for continual improvement of our system to ensure that all our customer requirements are consistently met.
The well-equipped quality control laboratory performs the quality assessment using state-of-the-art instrumentation and procedures. Product is certified for patient use only upon conformity to the pre-established quality specifications and evidence of adherence to GMP. Additionally, all materials used in production of radiopharmaceuticals are tested to ensure suitable quality.
In addition to the extensive testing at different stages of manufacturing, QC/QA Section implements validation and stability studies, makes in-process/packaging inspections and prepares proper documentation and record keeping of all data. C&RD activities include development of methods of analysis and collaboration in improving manufacturing methods.
- Research Section
Research Section staff engages in development of new radioisotopes and radiotracers, which are the investigational products that are uniquely designed to probe biochemical and physiological processes at the molecular level for non-invasive assessment of a disease through molecular imaging. As such these compounds hold a great promise in design of new pharmaceuticals derived from advancements in molecular genetics and gene therapy. A well-designed molecule labeled with an appropriate radioisotope has the potential to probe specific biological systems in vivo with minimum perturbation of the whole organism. The staff aims to develop organ-specific radiotracers through hypothesis driven research that entails developing radiolabeling procedures culminating into bioactive molecules tagged with radioisotopes. Active research projects culminate into several publications and presentations at international conferences. The latest addition of the micro-PET/CT (small animal imaging modality) will further augment our efforts in improving the molecular imaging section within the research center. With addition of this research imaging tool, the group aims to perform basic and applied molecular imaging and radiotherapy research which will be greatly advanced.
