As Could We Assure Safety in Large-Scale Manufacturing of Nanoparticles for the Biomedical Use

Abstract

Nanoparticles provide great advantages but also great risks. Risks associating with nanoparticles are the problem of all technologies, but they increase in many times in nanotechnologies. Adequate methods of outgoing production inspection are necessary to solve the problem of risks, and the inspection must be based on the safety standard. Existing safety standard results 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 doesn’t exist. Essence of the risks is illustrated by the example from pharmacology, since its safety assurance is conceptually based on MPC and it has already come against this problem. Possible formula of safety standard for nanoparticles is reflected in many publications, but conventional inspection methods cannot provide its realization, and this gap is an obstacle to assumption of similar formulas. Therefore the development of nanoparticle industry as a whole (also development of the pharmacology in particular) is impossible without the creation of an adequate inspection method. There are suggested new inspection methods founded on the new physical principle and satisfying to the adequate safety standard for nanoparticles. These methods demonstrate that creation of the adequate safety standard and the outgoing production inspection in a large-scale manufacturing of nanoparticles are the solvable problems. However there is a great distance between the physical principle and its hardware realization, and a transition from the principle to the hardware demands great intellectual and material costs. Therefore it is desirable to call attention of the public at large to the necessity of urgent expansions of investigations associated with outgoing inspections in nanoparticles technologies. It is necessary also to attract attention, first, of representatives of state structures controlling approvals of the adequate safety standard to this problem, since it is impossible to compel producers providing the safety without the similar standard, and, second, of leaders of pharmacological industry, since their industry already entered into the nanotechnology era, and they have taken an interest in a forthcoming development of inspection methods.