What is ISO 16640 about?
When you manufacture radiopharmaceuticals, you need to monitor the air quality for radioactive gases in effluents. ISO 16640 focuses on monitoring the activity concentrations of radioactive gases. They allow the calculation of the activity releases, in the gaseous effluent discharge from facilities producing positron-emitting radionuclides and radiopharmaceuticals.
The criteria and recommendations of ISO 16640 are aimed at monitoring which is conducted for regulatory compliance and system control. If existing air monitoring systems were not designed according to the performance criteria and recommendations of ISO 16640, an evaluation of the performance of the system is advised. If deficiencies are discovered based on a performance evaluation, a determination of the need for a system retrofit is to be made and corrective actions adopted where practicable.
Note: The criteria and recommendations of ISO 16640 apply under both normal and off‑normal operating conditions, provided that these conditions do not include the production of aerosols or vapours. If the normal and/or off-normal conditions produce aerosols and vapours, then the aerosol collection principles apply.
Who is ISO 16640 for?
ISO 16640 on positron-emitting radionuclides and radiopharmaceuticals is useful for:
- Pharmaceutical firms
- Nuclear facilities
- Laboratories and research facilities
Why should you use ISO 16640?
ISO 16640 provides performance‑based criteria for the design and use of air monitoring equipment including probes, transport lines, sample monitoring instruments, and gas flow measuring methods.
ISO 16640 provides information on monitoring program objectives, quality assurance, development of air monitoring control action levels, system optimization and system performance verification.