Purified water equipment for pharmaceutical industry

Overview

Water is the most widely used basic raw material in drug production. It is used in the production process and the preparation of pharmaceutical preparations. Pharmaceutical water is the lifeline of the pharmaceutical industry.

With the continuous progress of science and technology, the preparation technology of pharmaceutical water has also undergone revolutionary changes. In many developed countries in the world, such as the United States, the limitation that water for injection (WFI) must be prepared by distillation has long been broken through. Highly Purified Water HPW and its preparation are more advanced in technology, more energy-saving, and more stable and reliable in quality. The process has been officially confirmed as early as 1975 (United States Pharmacopoeia 19th Edition: USP19). Now, the United States Pharmacopoeia has clearly confirmed in its 7 consecutive editions that the reverse osmosis (RO)-based HPW process can be used as a legal process for the preparation of water for injection, and, after decades of medical practice, HPW water for injection production technology It has been proven to be one of the most advanced and reliable methods, so much so that among the 25 drug technologies in the United States, the reverse osmosis method is the most commonly used water for injection production process. Since HPW meets or even exceeds the physical and chemical parameters of WFI, it has been officially recognized as the third water quality level in Europe since June 2002. Today, RO-based HPW has been confirmed by major developed countries in the world representing advanced medical technology, and has become one of the standard preparation methods for medical purified water.

In the process of aligning with international standards, the Chinese Pharmacopoeia also redefines the legal preparation method of medicinal water. The pharmaceutical water contained in the Chinese Pharmacopoeia (2000 edition) has made great progress compared with the past. It is divided into purified water, water for injection and sterilized water for injection because of its different scope of use. For the first time, the distilled water in the past was changed to purified water. , and the purified water is specifically defined as “purified water is water for medicinal use obtained by distillation, ion exchange, reverse osmosis or other suitable methods”, which actually gives up the production process “must be distillation”. It has laid a legal basis for the relevant enterprises to use the internationally popular reverse osmosis HPW method to prepare purified water. More importantly, the new National Pharmacopoeia defines water for injection as “water obtained by distillation of purified water”, thus making it possible for RO technology to enter the water for injection preparation process. The 2000 edition of the National Pharmacopoeia has taken a big step towards the international advanced field in restricting water use technology.

Comparison

Compared with the traditional distillation method, the new process based on reverse osmosis combined with the latest electrodeionization (EDI) technology has obvious advantages and advancement.

  1. High efficiency and energy saving. Distillation method is the longest history of medicinal water preparation process, mainly multi-stage distillation, high pressure fractional distillation and centrifugal purification distillation several processes. All distillation methods are carried out at a high temperature of 120°C, so completely sterile water can be obtained. Therefore, the energy consumption during operation is quite large; at the same time, because of the high temperature, all equipment components must withstand high temperature shocks, and the equipment cost and maintenance costs are high. HPW process adopts very mature reverse osmosis technology, combined with high-efficiency ozone disinfection method, the whole system works at normal temperature and low pressure, with low equipment investment, low operation and maintenance cost, reliable energy saving: the operating cost of membrane treatment method is only 12- 15%, very economical and very competitive.
  2. Stable and reliable. With the continuous acceleration of the industrialization process, the discharge of a large number of wastes with complex components makes the worldwide pollution become increasingly serious, and the pollution of water resources is more serious than before. Because the boiling point of volatile organic pollutants is mostly lower than the vaporization temperature of water, if they are not treated, they will easily enter into the produced water during the distillation process. The simple distillation method cannot effectively remove them. It must rely on filtration methods such as activated carbon adsorption to increase the system and water quality instability. The membrane process uses a multi-media filter for pretreatment; the microporous permeation working principle of the reverse osmosis membrane ensures the removal of all larger ions and molecules in the water body, and can easily remove volatile organic pollutants with larger molecular diameters. Fundamentally ensure that the index of organic matter reaches the index specified in the Pharmacopoeia.
  3. Advanced environmental protection. The replacement of the traditional pure distillation method by the membrane method combined process has become the mainstream of the world’s medical water production technology. In recent years, the emergence of Continuous Electrodeionization (CEDI), which represents the highest technical level in the preparation of pharmaceutical water, has prompted the preparation of medicinal water to abandon the traditional ion exchange technology associated with waste acid and waste alkali pollution, and enable the system to realize fully automatic computer control. , Continuous production, safe and pollution-free. The fundamental of CEDI technology is the ingenious combination of traditional ion exchange and electrodialysis technology: under the action of an electric field, the ions in the anion and cation exchange resins migrate in a direction, and the migrated ion holes are filled by the anions and cations in the water. The polishing and regeneration of the resin is achieved while the ions move to the ion permeable membrane; the ions after passing through the selective permeation membrane will be trapped in the channel called “concentrated water chamber” and discharged together with the “concentrated water”. The resin usage of the CEDI system is only 5% of the traditional mixed bed, which is cost-effective. At the same time, since most of the gases dissolved in water, such as carbon dioxide, are weakly charged, CEDI can effectively remove them; especially the gram-negative bacteria that have a greater impact on medicinal water are negatively charged and will be adsorbed on cation exchange. The resin surface, which is in the most active area of ​​hydrolysis, is completely killed.

Xi’an CHIWATEC Water Treatment Technology is a high-tech enterprise specialized in various water processing devices. Aside from these individual products, which cover a number of types and series, we can also help with related comprehensive engineering projects. Thanks to our hard work and dedication upon our founding, we are now one of the fastest-developing water treatment equipment manufacturers in Western China.

Further reading:

Water Treatment Systems & Reverse Osmosis in Pharmaceutical

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