The production of pharmaceuticals is an incredibly complex regulated process. Great importance is placed on the quality of components used in factories and plants. So, for the manufacture of liquid drugs intended for injection, specially prepared and purified water is used. It should not contain harmful microorganisms and foreign impurities. If this is discovered at the stage of laboratory testing and examination of the drug, all batches of the drug will have to be withdrawn. That is why water for injections at pharmaceutical enterprises is prepared in a special way, for which modern technological solutions and professional equipment are used.
Two types of prepared liquids are used for the manufacture of pharmaceutical preparations:
Purified water. Its production, technical and operational parameters are regulated by the FS 42 2619-97 standard. For water treatment, mainly three technological methods are used - electrodeionization, distillation and reverse osmosis. Purified water is used in the production of medicines, the sterility of which is not subject to special requirements, as well as for the manufacture of food additives. It is important that professional installations are used in the manufacture, capable of providing multi-stage water purification. Every year, the requirements for the quality of equipment are increasing, which must have high productivity, safety, and be automated to minimize the production of liquids with a low-quality composition. Using purified water, rectal and vaginal suppositories are produced,
Water for injections. Its production is also regulated by the pharmacopoeial article FS 42 2620-97. Unlike water purified for the production of non-sterile drugs, liquids used in the manufacture of injections have a pyrogenicity limit. We are talking about the ability of injectable solutions to cause fever in patients. Every year the requirements for such water increase, and experts carefully monitor that the solutions correspond to microbiological indicators. The most common way to obtain water for injection with high purification rates is distillation. It is she who allows for the effective removal of pyrogenic particles. In addition, distillation plants are characterized by a simple and reliable design, although their operation and maintenance costs are still high.
As noted above, three main water treatment technologies are used to produce water for medicines.
Electrodeionization.Today it is one of the cost-effective ways of continuous water treatment. The technique allows for deep water purification, involving three technological processes at once: electrodialysis, ion exchange and regeneration. The first causes metal and acid ions to move under the action of an electric current to electrodes with an opposite charge. The second is responsible for extracting ions of harmful bacteria and impurities, and the third allows you to restore the ion exchange of resins. Electrodeionization plants were first invented in the fifties of the last century, and already in the 1980s they began to be widely used in water treatment plants. To this day, such professional equipment is considered modern and allows solving important problems in the field of water purification. An important advantage of the installations is low operating costs,
Reverse osmosis. Today it is one of the most efficient water treatment methods for pharmaceutical companies. It was developed in the 50s of the last century. Its peculiarity is the use of special synthetic semi-permeable membranes. Passing through them, the water is purified from impurities and mineral salts, and the purity rate is 98% - 99%. Reverse osmosis plants have several significant advantages. They are universal and suitable for all pharmaceutical enterprises where it is necessary to obtain purified water for the production of non-sterile drugs. Today, there is a small range of installations on the market that allow you to obtain the necessary performance indicators. With the help of such equipment, water desalination can be carried out. Devices differ in price and operating costs.
Distillation . This is a common method of water treatment, which is used everywhere not only in the pharmaceutical industry, but also in other industries. The technique is based on evaporation and subsequent condensation of liquids. Due to this, most of the impurities of both organic and inorganic origin are removed from the water. In addition to distillation, other technological methods can be used to improve water quality, for example, disinfection or purification using membranes.
CHUANYA is a professional in the field of water treatment. The pharmaceutical division has many years of experience in the preparation of clean media and uses all modern developments, technologies and equipment for this. The organization has a positive experience of cooperation with international corporations,