Insights into Terminal Sterilization Processes of Nanoparticles for Biomedical Applications

Nanoparticles possess a huge potential to be employed in numerous biomedical purposes; their applications may include drug delivery systems, gene therapy, and tissue engineering. However, the in vivo use in biomedical applications requires that nanoparticles exhibit sterility. Thus, diverse sterilization techniques have been developed to remove or destroy microbial contamination. The main sterilization methods include sterile filtration, autoclaving, ionizing radiation, and nonionizing radiation. Nonetheless, the sterilization processes can alter the stability, zeta potential, average particle size, and polydispersity index of diverse types of nanoparticles, depending on their composition. Thus, these methods may produce unwanted effects on the nanoparticles’ characteristics, affecting their safety and efficacy. Moreover, each sterilization method possesses advantages and drawbacks; thus, the suitable method’s choice depends on diverse factors such as the formulation’s characteristics, batch volume, available methods, and desired application. In this article, we describe the current sterilization methods of nanoparticles. Moreover, we discuss the advantages and drawbacks of these methods, pointing out the changes in nanoparticles’ biological and physicochemical characteristics after sterilization. Our main objective was to offer a comprehensive overview of terminal sterilization processes of nanoparticles for biomedical applications.

Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals

This guideline on current good radiopharmacy practice (cGRPP) for small-scale preparation of radiopharmaceuticals represents the view of the Radiopharmacy Committee of the European Association of Nuclear Medicine (EANM). The guideline is laid out in the format of the EU Good Manufacturing Practice (GMP) guidelines as defined in EudraLex volume 4. It is intended for non-commercial sites such as hospital radiopharmacies, nuclear medicine departments, research PET centres and in general any healthcare establishments. In the first section, general aspects which are applicable to all levels of operations are discussed. The second section discusses the preparation of small-scale radiopharmaceuticals (SSRP) using licensed generators and kits. Finally, the third section goes into the more complex preparation of SSRP from non-licensed starting materials, often requiring a purification step and sterile filtration. The intention is that the guideline will assist radiopharmacies in the preparation of diagnostic and therapeutic SSRP’s safe for human administration.

Use of 99m Tc in The Field of Radiofarmation: A Review

A B S T R A C TTechnetium-99m ( 99m Tc) has been applied in nuclear medicine as a radiopharmacyfor both diagnosis and therapy. 99m Tc is obtained from a 99 Mo/ 99m Tc (half-life 66 h)generator in the form of sodium pertechnetate (Na[ 99m TcO 4 ]) by decaying to 99 Tc for 6hours and emitting gamma energy rays (Eɤ = 140 keV). This radionuclide has anelectron configuration of 4d 5 5s 2 , which will form complexes with different ligandsand have oxidation rates from +1 to +7. The coordinated complex of technetium-99mhas been utilized in nuclear medicine in tissues and organs (thyroid, red and whiteblood cells, kidneys, brain, myocardial, and bone). The resulting kit production musthave based on Good Manufacturing Practice, which consists of batch planning,washing, sterilization of glassware and stopper, starting material, preparation oflarge quantities of the solution, sterile filtration, dispensing, crimping, a summary ofprocess control, quarantine, packaging and leaving the production premises.