Use of Ionizing Radiation in the Manufacture of
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This document defines key terms related to ionizing radiation such as radioactivity, radioactive decay, and radiopharmaceuticals. It then discusses the manufacture of radiopharmaceuticals through various production methods like radionuclide generators and particle bombardment. The use of ionizing radiation for sterilization is covered along with its advantages and disadvantages. Finally, the importance of radiation monitoring and guidelines for safe use of radiation in drug manufacturing are presented.
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Use of Ionizing Radiation in the Manufacture of
- 2. Outline I. Introduction to Ionizing Radiation II. Manufacture of Radiopharmaceuticals III. Radiation as Means of Sterilization IV. Radiation Monitoring V. Guidelines for Using Radiation in the Manufacture of Drugs
- 3. Definition of Terms • Radiation – energy transmitted from a source – 2 types: • Non-ionizing radiation • Ionizing radiation Ionizing Radiation Non-ionizing Radiation
- 4. Definition of Terms • Radioactivity – the process in which an unstable isotope undergoes changes until a stable state is reached and in the transformation emits energy in the form of radiation • Radioisotope – radioactive atoms of an element with different number of neutrons
- 5. Definition of Terms • Radioactive Decay – the process in which an unstable atomic nucleus spontaneously loses energy by emitting ionizing particles and radiation – parent nuclide transforming to an atom of a different type, named the daughter nuclide – Types of emitted radiation: • Alpha • Beta • Gamma
- 6. Definition of Terms • Radiopharmaceuticals – A preparation, intended for in vivo use, that contains a radionuclide in the form of an element, simple salt or a complex – Used for diagnosis and therapy • Radiopharmacy – also known as nuclear pharmacy – specialty area of pharmacy practice dedicated to the compounding and dispensing of radioactive materials for use in nuclear medicine procedures
- 7. Ionizing Radiation • Alpha – 2 protons, 2 neutrons – completely blocked when it hits matter
- 8. Ionizing Radiation • Beta – Negatron or positron – Used more commonly than alpha
- 9. Ionizing Radiation • Gamma – Electromagnetic – Radiated as photons of energy – Most penetrating type
- 11. Ideal Radionuclides • Readily Available, Easily Produced & Inexpensive • High Target to Non target Ratio – maximize the efficacy of diagnosis – minimize the radiation dose to the patient • Effective Half-life – It should be short enough to minimize the radiation dose to patients and long enough to perform the procedure. Ideally 1.5 times the duration of the diagnostic procedure.
- 12. Production of Radiopharmaceuticals • Preparation of Radiopharmaceuticals – Reconstitution of reagent kits
- 13. Production of Radionuclides • Preparation of Radionuclides – Radionuclide generators – Charged particle bombardment – Neutron Bombardment
- 14. Production of Radionuclides • Radionuclide generators – A long-lived parent radionuclide is allowed to decay to its short-lived daughter radionuclide and the latter is chemically separated in a physiological solution.
- 15. Production of Radionuclides • Charged Particle Bombardment – bombarding target materials with charged particles in particle accelarators such as cyclotrons.
- 17. Production of Radionuclides • Neutron Bombardment – bombarding target materials with neutrons in nuclear reactors – majority of radiopharmaceuticals are produced by this process
- 18. IONIZING RADIATION AS MEANS OF STERILIZATION
- 19. Sterilization • Sterilization – Complete destruction or removal of all forms of contaminating microorganisms – Methods of Sterilization • Steam Sterilization • Dry-heat Sterilization • Filtration Sterilization • Exposure to Ionizing Radiation • Gas Sterilization
- 20. Sterilization by Radiation Advantages Disadvantages • Gamma radiation easily reaches all • very dangerous parts of the object to be sterilized • only well-trained and experienced • Permits sterilization of heat- staff should decide upon the sensitive materials desirability of their use • Relatively low chemical reactivity • should ensure monitoring of the • Instantaneous and simultaneous processes sterilizing effect • specially designed and purpose- built installations and equipment must be used
- 21. Sterilization by Radiation • Sterilization of certain active ingredients, drug products, and medical devices in their final container • exposure to gamma radiation (60Co) or of electrons energized by a suitable electron accelerator
- 22. Sterilization by Radiation • Principle Involved – effect ionization of the molecules in organisms – mutations are thus formed in the DNA and these reactions alter replication
- 26. Radiation Monitoring • Dosimeters – used to monitor radiation – monitors dose distribution of the product – exposure time required to achieve a required specified dose
- 27. Radiation Monitoring • Dosimeters – only measures external radiation exposure – offers no protection from radiation – Types • Ring dosimeter • Whole body dosimeter
- 28. GUIDELINES FOR USING RADIATION IN THE MANUFACTURE OF DRUGS
- 29. Guidelines • Requires well-planned techniques and procedures • Requires the use of personal film badges or thermoluminescent dosimeters (TLDs) must be worn at all times • Suitable electronic radiation detector should always be available when radioactive materials are manipulated
- 30. Guidelines • Required radiation monitoring – External radiation – Air contamination – Personnel Monitoring • Appropriate shielding • Radioactive waste disposal procedures • Necessary decontamination methods
- 31. References ALLEN, LV, Popovich, NG, Ansel, HC. 2005. Ansel's pharmaceutical dosage forms and drug delivery systems. Philadelphia: Lippincott Williams & Wilkins. GENNARO, AR. 2000. Remington: the science and practice of pharmacy. Philadelphia: Lippincott Williams & Wilkins. HARVARD CAMPUS SCIENCES. Dosimetry. [online]. [Accessed 22 September 2012]. Available from World Wide Web: <http://www.uos.harvard.edu/ehs/radiation/dosimetry.shtml> INSTITUTE OF MEDICINE. Radiation in Medicine: A Need for Regulatory Reform. [online]. [Accessed 22 September 2012]. Available from World Wide Web: <http://www.nap.edu/openbook.php?record_id=5154&page=R1> MUKHERJEE, RN. Radiation: a means of sterilization. [online]. [Accessed 22 September 2012]. Available from World Wide Web: <https://docs.google.com/viewer?a=v&q=cache:7FEpgTLvrsQJ:www.iaea.org/Publications/Magazines/Bulletin/Bull176/17605882837.pdf+&h l=en&gl=ph&pid=bl&srcid=ADGEESgU6o8M7BzzHZV1w1XhFAT7x-4-IBcRBSN0Fd7MoNUd96nshS4KxRa_HgUz5158MEUDwPH3ALPJ9yDB- 414BHFcOs-OhAbQvPia> UNITED STATES ENVIRONMENTAL PROTECTION AGENCY. 2012. Radiation Protection. [online]. [Accessed 22 September 2012]. Available from World Wide Web: <http://www.epa.gov/rpdweb00/sources/food_irrad.html> US DEPARTMENT OF ENERGY. Radioisotopes: What Are They and How Are They Made? [online]. [Accessed 22 September 2012]. Available from World Wide Web: <http://hss.energy.gov/healthsafety/ohre/roadmap/achre/intro_9_4.html> WORLD HEALTH ORGANIZATION. 2012. Ionizing Radiation. [online]. [Accessed 22 September 2012]. Available from World Wide Web: <http://www.who.int/ionizing_radiation/about/what_is_ir/en/index.html> WORLD HEALTH ORGANIZATION. Methods of Analysis: Methods of sterilization. [online]. [Accessed 22 September 2012]. Available from World Wide Web: <http://apps.who.int/phint/en/p/docf/> WORLD NUCLEAR ASSOCIATION. What is radiation? [online]. [Accessed 22 September 2012]. Available from World Wide Web: <http://www.world-nuclear.org/how/radiation.html>
Editor's Notes
- *Radiopharmaceuticals -
- *Radiopharmaceuticals -
- *Radiopharmaceuticals -
- Alpha and Beta particles release large amounts of energy over a short distance. They are locally destructive to the tissue.Useful as therapeutic agents of deposited internally
- Useful diagnostic radiopharmaceuticalsOnce the radiopharmaceutical has distributed within the body, the photons can penetrate the tissues and be detected externally by an imaging device
- 99Mo is immobilized in the alumina column0.9% saline solution (the eluent) is passed through the column and Na pertechnetate, the product of the decay of 99Mo, is elutedPertechnetate is collected and shielded by lead
- 99Mo is immobilized in the alumina column0.9% saline solution (the eluent) is passed through the column and Na pertechnetate, the product of the decay of 99Mo, is elutedPertechnetate is collected and shielded by lead
- Radionuclides may be produced by bombarding target materials with charged particles in particle accelarators such as cyclotrons.A cyclotron consists of :Two flat hollow objects called dees.The dees are part of an electrical circuit.On the other side of the dees are large magnets that (drive) steer the injected charged particles (protons, deutrons, alpha and helium) in a circular pathThe charged particle follows a circular path until the particle has sufficient energy that it passes out of the field and interact with the target nucleus.
- Radionuclides may be produced by bombarding target materials with charged particles in particle accelarators such as cyclotrons.A cyclotron consists of :Two flat hollow objects called dees.The dees are part of an electrical circuit.On the other side of the dees are large magnets that (drive) steer the injected charged particles (protons, deutrons, alpha and helium) in a circular pathThe charged particle follows a circular path until the particle has sufficient energy that it passes out of the field and interact with the target nucleus.
- *Radiopharmaceuticals -
- Steam Sterilization (Autoclave)Exposure of microorganisms to saturated steam under pressure in an autoclave achieves their destruction by the irreversible denaturation of enzymes and structural proteins. Dry-heat Sterilizationoxidation of cell constituentsrequires a higher temperature than moist heat and a longer exposure timemore convenient for heat-stable, non-aqueous materials that cannot be sterilized by steam because of its deleterious effects or failure to penetrate. Such materials include glassware, powders, oils, and some oil-based injectablesFiltration Sterilizationemployed mainly for thermolabile solutionspassage through sterile bacteria-retaining filters, e.g. membrane filters (cellulose derivatives, etc.), plastic, porous ceramic, or suitable sintered glass filters, or combinations of thesefiltration must be followed by an aseptic transfer of the sterilized solution to the final containersGas Sterilizationuse of ethylene oxide or another highly volatile substanceafter sterilization, time should be allowed for the elimination of residual sterilizing agents and other volatile residues, which should be confirmed by specific tests.
- Gamma rays for sterilization are usually derived from cobalt-60 source, the isotope is held as pellets packed in metal rods, each rod carefully arranged within the source and containing 20 KCi of activity. This source is housed within a reinforced concretebuilding with 2 m thick walls. Articles being sterilized are passed through the irradiation chamber on a conveyor belt and move around the raised source.
- Gamma rays for sterilization are usually derived from cobalt-60 source, the isotope is held as pellets packed in metal rods, each rod carefully arranged within the source and containing 20 KCi of activity. This source is housed within a reinforced concretebuilding with 2 m thick walls. Articles being sterilized are passed through the irradiation chamber on a conveyor belt and move around the raised source.
- Gamma rays for sterilization are usually derived from cobalt-60 source, the isotope is held as pellets packed in metal rods, each rod carefully arranged within the source and containing 20 KCi of activity. This source is housed within a reinforced concretebuilding with 2 m thick walls. Articles being sterilized are passed through the irradiation chamber on a conveyor belt and move around the raised source.
- *Radiopharmaceuticals -
- *Radiopharmaceuticals -