Development of micellar system for the decontamination of organophosphorus compounds to clean technological equipment

An analysis of composition of commercially available cleaning products, used in pharmaceutical enterprises today, was carried out, based on which it was found that they do not guarantee effective cleaning of equipment from organophosphorus compounds. It was concluded that the development of new composition of the cleaning agent, which effectively decontaminates organophosphorus compounds from surfaces of the equipment, is a pressing issue for ecologically safe manufacture of products containing substances of organophosphorus nature. A new system of micellar inactivation of active pharmaceutical ingredients of organophosphorus nature was developed. We conducted a study into the destruction of methylparathion by using the micellar system, which includes water, cetylpyridine chloride, hydrogen peroxide and boric acid. A concentration of cetylpyridine chloride, at which the largest constant of first-order reaction rate occurred, was established. It is shown that adding the activator, boric acid, increases the reaction rate by 2.5 times. Based on these studies, the composition of a model cleaning agent for cleaning technological equipment was proposed. An assessment of internal risks for quality of production stations when producing medicinal agent based on organophosphorus compounds in the form of eye drops was carried out. Production station was given the highest rating of internal risk – 3. We carried out an analysis of risks for cleaning reactor for preparing solutions RVD-630 in case of using the micellar system developed to decontaminate from residues of active pharmaceutical ingredients of organophosphorus nature. The obtained results might be used for devising the concept of validation of cleaning the reactor in the preparation of solutions. This is an important step in providing cleanliness of technological equipment under conditions of producing medicines based on organophosphorus compounds as active pharmaceutical ingredients at operating pharmaceutical enterprises.