Radiopharmacy Design Principles
Radiopharmacies have special equipment and facilities for the preparation of radiopharmaceuticals which satisfy both radiation safety and pharmaceutical quality requirements. However, the design of a radiopharmacy largely depends on the daily work to be undertaken and on the national regulations of each country.
Nevertheless, some general principles regarding radiopharmacy design should be followed:
- Radiopharmaceuticals should be prepared in a well-shielded room with an appropriate ventilation system and lead shielding for handling radioactive materials, also called a hot lab. The hotlab may also be a clean room. All radiation exposures should be kept as low as reasonably achievable.
- An entrance or changing area should be provided for putting on and removing protective clothing before and after working in the hot-lab.
The Laminar Airflow (LAF Cabinet)
As most 99mTc-radiopharmaceuticals (including 99mTc-MDP) are intended for intravenous administration, they have to be sterile. Therefore, their preparation must be performed in a cabinet with class 100 laminar air flow ( a so called LAF cabinet). A word station is rated "Class 100" where there exists no more than 100 particles per cubic metre.
A laminar air flow sstem should provide a homogeneous air speed in a range of 0.36 - 0.54 m/s (guidance value) at the working position in open room applications. A LAF cabinet for preparation and handling of radiopharmaceuticals has a lead glass screen in the centre to protect the person preparing the radiopharmaceutical from unnecessary exposure to radioactive sources. There is usually a waste bin, for teh disposal of radioactive waste, within the LAF cabinet.
O Switch for air flow turn on and adjustment |
O Lead glass screen |
O Sterile absorbing paper |
O Dipper of dose calibrator |
O Bin for radioactive waste |
It is also possible to perfom such preparations in a completely closed work station (a so-called "isolator" or self containment station). In this case, the requirements with respect to protective clothing are less stringent.
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