Radiation

The use of radiation in the diagnosis and treatment of patients has considerably advanced the medical field, and has extended and saved numerous lives. Radiation usage come with risks. To ensure safety, it is mandatory that personnel involved in practices with radiation be trained in radiation safety, radiation physics, biologic effects of radiation, injury prevention, among others.

Standard procedures, best practices, facilities, and equipment for the preparation and dispensing of radiopharmaceuticals are essential to any radiopharmacy operation. Appropriate engineering controls and work practices are intended to ensure the sterility of compounded preparations as well as protection of the operator from exposure to radioactivity. It is important to note that using engineering controls and proper standard operating procedures do not totally eliminate radiation. It only minimizes or attenuates the dose that the operator is exposed to.

Radiation safety conditions, as stated in the United States Pharmacopeia (USP) General Chapter 825, take into account 4 main factors: time, distance, shielding and radiation contamination control. Time handling radioactive materials (RAMs) is directly proportional to radiation exposure; hence, minimizing handling time will minimize radiation exposure. Distance, on the other hand, follows the inverse square law. Thus, increase in distance between the personnel and RAM will decrease radiation exposure to the worker by square of the distance. Use of shielding materials (e.g., lead, tungsten) also decreases radiation exposure to personnel. For this reason, the use of shielding (e.g., L-block, torso, vial, and syringe shields) is often required through the radiopharmaceutical handling processing, including within a primary engineering control (PEC). Primary engineering control (PEC) is defined as a device or zone that provides an ISO Class 5 air quality environment for sterile compounding. Lastly, RAM contamination (e.g., spills, drips, sprays, volatility) is vital with regard to radiation protection. Therefore, application of various techniques and materials may be done in order to minimize radioactive contaminations.

Esco is committed in providing quality equipment with the highest level of containment to protect the operator, product and the environment from hazardous substances.

Esco Radiopharmacy Compounding Equipment

• Esco Frontier® Radioisotope Fume Hood

  For Superior Protection of Radioisotope Laboratories

  The Esco Radioisotope Fume Hood is designed for radiopharmaceutical dispensing and protects the operator during dispensing and QC checks involving radioisotopes.

• Radiopharmacy Hood (Lead-Shielded Biosafety Cabinet)

  For Superior Protection of Radioisotope Laboratories

  The Esco Lead-shielded Biosafety Cabinet offers superior protection for radioisotope laboratories. It is designed for radiopharmaceutical dispensing of generator-produced radioisotopes and dose calibration of all radioisotopes.

• Cytoculture® Lead-Shielded Biosafety Cabinet

  For Superior Protection of Radioisotope Laboratories

  The Esco Cytoculture® Lead-Shielded Class II Biosafety Cabinet is designed for radiopharmaceuticals handling and provides operator protection during work involving radioisotopes.

• Blood Cell Labelling Isolator

  For Aseptic Manipulation and Radiolabelling of blood cells

  Blood Cell Labelling Isolator is designed for aseptic manipulation and radiolabelling of blood cells. It is configured to operate at a negative pressure in a single pass airflow. It provides a comprehensive personnel and product protection.

• Technetium Dispensing Isolator

  For Safe Handling of Radiopharmaceuticals

  Radioisotope Dispensing Isolator is designed to provide safe, controlled, and sterile environment for elution and dispensing of radiopharmaceuticals. It is configured to operate at a negative pressure in a single pass airflow. It provides a comprehensive personnel and product protection.

• GMP-Compliant Radioisotope Dispensing Isolator

  For Aseptic Preparation and Dispensing of Radiopharmaceuticals

  The GMP-compliant Radioisotope Isolator is designed for the aseptic elution and dispensing of generator-produced radioisotopes, such as Tc-⁹9m and Ga-68. It is configured to operate at a negative pressure in a single pass airflow. It provides a comprehensive personnel and product protection.

References:

1. United States Pharmacopeia. (2019).USP 42—NF 37: USP General Chapter <825> Pharmaceutical Compounding – Radiopharmaceuticals. United States Pharmacopeial Convention.