Fundamentals of Radioisotopes

Fundamentals of Radioisotopes and Radiation Technology (Training Report)

Nepal is in the phase of development of nuclear act, policy and guidelines.  So, it is crucial to know

the practices from other countries. The reasons behind the lack of radiopharmaceuticals in the developing countries like Nepal are: 

• ·         Lack of infrastructures and legislation
• ·         Lack of training and education
• ·         Regulatory issues
• ·         Implementation of technology

The role of IAEA  in the developing countries like Nepal as:

• ·         Education such as e-learning, training modules, syllabus development and so on
• ·     Help in solving regulatory issues such as; mandatory requirement of safety. Due to the increasing complexity of radiopharmaceutical preparations and the mandatory requirement of patient’s safety, there exists a widespread demand to support regulators and preparation of guidelines of Good Manufacturing Practice (GMP)
•       Meetings, workshops, conferences

After act is prepared, Nepal can take the advantage from IAEA to establish the National Facility for Radiopharmaceutical Production to Meet with International Quality Standards through RCA projects.

Basics about Radiation Technology

When the nucleus is unstable and it is giving off energy or particles to become stable. So it goes through a SERIES of radioactive decay until it becomes an element that is no longer unstable (Lee, 2018)

• ·         Radiation cannot be felt
• ·         Measurable only with detector
• ·         Radioactivity cannot be artificially destroyed 

Estimated whole body dose per each medical procedure

Daily Life and Radiation (mrem) ; 1mrem =0.01msev

Source: Research Institute of Radiation Health, Korea

Exemption and Consideration

Exemption and Consideration of Range of Regulation in international practice (Kim, 2018)

• ·         Exemption criteria (IAEA GSR Part 3) mentions
• ·         Effective dose : 10 µsv per year.
• ·         Collective effective dose : 1 person.Sv
• ·         Type approved sealed radioactive sources
• ·         ≤ 1 µsv/h at 0.1 m from any accessible surface of the device;
• ·         The dose to members of the public ≤ 10 µsv/yr
• ·         Type approved electrical apparatus
• ·         ≤ 1 µsv/h at 0.1 m from any accessible surface of the apparatus; or
• ·         The maximum radiation energy is 5 kev

Further, the international practice of exemption and consideration of range of regulation are:

However, some sources are not amenable to control, e.g.

• ·         40K in the body;
• ·         cosmic radiation at the surface of the earth;
• ·          low concentrations of naturally occurring radionuclides in raw materials

Exemption applies if either the Activity Concentration or the Activity does not exceed the limits as provided below:

Clearance Types
Unconditional clearance	Conditional clearance
No further control	First destination of the material is known and after that no further control.

Notification and Authorization of Material flowchart

Risk Matrix

Source Categories

This categorization can be used in determining the graded approach to notification and authorization.
Conclusion

The IAEA can assist Nepal in through various types of activities. However, Lack of infrastructures and legislation, Lack of training and education, Regulatory issues and issue of Implementation of technology is becoming the factors preventing the assistance to Nepal.

References

Slides of training classes

Kim, H. (2018, Sept). Regulatory Control. Korea: Kins.

Lee, Y. J. (2018, Sept). Basic knowledge ofradiation technology . Korea: Advanced Radiation Technology Institute.