REVIEW OF METHODS FOR PREPARING HIGHLY PURIFIED WATER FOR INJECTIONS. ENVIRONMENTAL ASPECTS

Abstract

The development of the pharmaceutical industry is important for humanity because it ensures a better standard of living. The development of new drugs makes it possible to overcome diseases that were previously considered incurable. One of the key aspects of ensuring the proper quality of medicines is the use of water of appropriate quality. According to the State Pharmacopoeia of Ukraine, water is classified as purified water, highly purified water, and water for injection. The latter is subject to the most stringent requirements, such as the complete absence of pyrogens, organic and inorganic impurities, and sterility. It is used to prepare injection solutions and other medicines that are administered directly into the bloodstream, so inadequate water quality can cause adverse reactions in the body or even pose a threat to the patient’s life. Water for injections is a key component in the production of sterile medicinal products for parenteral, ophthalmic, and inhalation use. It can also be used to prepare solutions for cell culture growth and to flush production equipment. The highest quality requirements are imposed on it, which in Ukraine are regulated by the provisions of the State Pharmacopoeia of Ukraine, harmonized with the relevant provisions of the European Pharmacopoeia. According to these documents, water for injections must not contain any impurities that could cause a negative reaction in the body or reduce the effectiveness of the drug. One of the main requirements is the complete absence of microorganisms and pyrogens, i.e., the water must not cause infection of the body or cause an increase in body temperature, increased heart rate, nausea, and other side effects when administered. Historically, distillation was the only legally approved method of obtaining water for injections in various countries, as it ensured the effective removal of bacteria and endotoxins from water. However, the development of membrane water treatment technologies has changed the approach to the development of WTI systems. In 2017, the European Pharmacopoeia allowed the use of reverse osmosis in combination with electrodeionization or ultrafiltration as a method equivalent to distillation. In 2024, the Ministry of Health of Ukraine took into account the changes in the European Pharmacopoeia, and the use of membrane methods became possible at pharmaceutical enterprises in Ukraine.