Safety in large-scale manufacturing of nanoparticles for bio-medical use

Abstract

Nanoparticles offer significant advantages but also great risks. Risks associated with nanoparticles are problems faced by all technologies, but they increase in many folds in nanotechnologies. Adequate methods for real-time production inspection are necessary to solve the problem of risks. Existing safety standards result from a principle of ‘maximum permissible concentrations or MPC’. This principle is not applicable to nanoparticles, but a safety standard reflecting risks inherent in nanoparticles does not exist. Possible approaches for safety standards of nanoparticles are reflected in many publications, but conventional inspection methods cannot provide its realization and this gap is an obstacle to assumption of similar solutions. Therefore, the development of nanoparticle industry as a whole (also development of the pharmacology industry in particular) is impossible without the creation of an adequate inspection method. There are newly suggested inspection methods that have been based on new physical principles and are satisfying to meet the adequate safety standards for handling nanoparticles. These methods demonstrate that the creation of acceptable safety standards and the real-time production inspection in large-scale manufacturing of nanoparticles are solvable problems. However, there is a large gap between the physical principles and its actual implementation and a transition from the principle to the hardware demands significant intellectual and material costs. Therefore, it is desirable to call the attention of the public at large to the necessity of urgent expansion of investigations associated with real time inspections in nanoparticle technologies.