Issues for Consideration
When preparing radiopharmaceuticals, consideration should be given to the following general principles:
- For patients - all radiopharmaceuticals must be prepared in accordance with pharmaceutical quality requirements; radiopharmaceuticals for parenteral administration must be protected from any airborne contamination (dust and other particles which may be present in the environment or originate from the operator or accessory materials) as much as possible.
For personnel and environment - during the preparation and handling of radiopharmaceuticals the personnel should be adequately protected against the hazards of external radiation. Both the personnel and environment should be protected against contamination with radioactive or biological materials, although standards of protection vary from country to country.
Quality of the radiopharmaceutical
The radiopharmaceutical should comply with the requirements set out in a monograph of a pharmacopoeia or in an in-house monograph. Such requirements are related to radioactivity, identity, radionuclidic, radiochemical and chemical purity, sterility and apyrogenicity, pH, isotonicity, level of residual solvents. These concepts are described in detail in the Quality Control Module.
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