Radiopharmaceuticals parenteral preparations

Radiopharmaceuticals for parenteral use must comply with the Ph. Eur. mmiograph for parenteral preparations, so they have to be sterile and with a very low or absent endotoxin COTicentration. For parenteral administration a sterile injectirm in a disposable injection syringe is often filled from a multiple dose solution in a glass vial. 

Finished parenteral products prepared in the radiopharmacy department must be sterile. Based on a risk analysis one may conclude that the risk of non-sterility is very low for standard radiopharmaceutical kit preparations. The risk of contamination is somewhat higher for the eluate from radionuclide generators, especially when they are used for a long period. The injection bottle on top of a Tc generator (sterile sodium chloride solution for injection) is changed asepti-cally each day however, the inside of the generator system is not sterilised nor disinfected. For that reason it is recommended to control the microbiological quality of the... 

Identity and purity, stability, and sterility and apyrogenicity. The identity and purity of radiopharmaceuticals is verified by determining the radionuclidic and radiochemical purity. Stability concerns the radioactive label, which is related to radiochemical purity at a certain time after preparation. Since Tc pharmaceuticals are formulated as sterile, pyrogen-free solutions, the safety requirements of drugs for parenteral use do apply. Safe handling of the radionuclide is equally important and must comply with Euratom Directives, regulated by national law for radiation protection, which also concerns the application of radionuclides in adults and in children for diagnostic procedures. 

Radiopharmaceuticals for parenteral administration should be sterile. Preparation under aseptic conditions should ensure this however, conditions and operator dispensing technique can be checked by carrying out sterility testing of products. 

Parenteral radiopharmaceuticals are available as a simple radimiuclide in solution, for instance I-sodium iodide solution for injection, or are prepared by labeUing a nOTi-radioactive pharmaceutical moiety (ligand) with a radimmclide. Many kits or Ugands for the preparation of radiopharmaceuticals are available in the form of sterile, freeze-dried powders in an injectimi vial. These kits are nOTi-radioactive. 

Also in this situation a separate room is required for preliminary operations, e.g. disinfection of utensils and surfaces of materials. In the preparation room medicines are reconstituted, e.g. filling of syringes, infusion bags, medication cartridges, disposable infusion pumps and irrigations. In addition, parenteral nutrition fluids, antineoplastics, radiopharmaceuticals and eye preparations may be prepared in these premises. Radiopharmaceuticals and other very... 

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