Key Differences Between Pharmaceutical Purified Water and Regular Water

In sectors such as pharmaceuticals, electronics, and food production, quality of water is a detail that you can afford to ignore for product safety, efficacy, and compliance. They understand this as well as WEMAC Pharma which has over 27 years of experience as a global supplier of pharmaceutical water systems. From multi-effect water distillers to pure steam generators, all solutions WEMAC offers are customized to meet the rigorous standards of pharmaceutical water. But what exactly sets pharmaceutical purified water apart from any other purified water? Let's dive into the answers.

Most water supplies, such as water from the tap, wells, rivers, or lakes, have a wide range of impurities, including calcium, magnesium and sodium minerals, bacteria, organic matter, and chemicals remaining from treatment processes e.g. chlorine. Impurities in water are normally safe for drinking and everyday use such as cooking and cleaning, but are unacceptable for use in pharmaceuticals.

Unlike other water, pharmaceutical grade water is issued from water sources subject to international restrictions and standards. For example, WEMAC applies the requirements of Good Manufacturing practices (GMP) in product development and thus does not the standards of a manufacturer. Wder for Injection (WFI) and other similar water from pharmaceuticals have been thoroughly tested and no longer contain impurities. Microbial counts are extremely low or, for all practical purposes, absent. Endotoxins, minerals, organic compounds, and other harmful bacterial cell wall constituents have, regrettably, been stringently measured as present in pharmaceutical grade water. WFI or Wder for Injection proved as the best, all other constituents in pharmaceutical products such as tablets, or biased grade essence of injections never get contaminated and retaining their intended lethality means losing such unbelievably lethal components is plenty plus.

Creating regular water is not overly complicated. Water from the faucet, for example, is subjected to basic treatment processes such as coagulation, sedimentation, filtration, and disinfection with chlorine or ozone, in that order. These processes add therapeutic value to the water and make it safe for daily use. All the large pathological and harmful macroparticles get removed, even though certain organic compounds and minerals remain.

The purified pharmaceutical water requires more sophisticated and complex processes, and for this, WEMAC is perfectly positioned. One basic approach is called multi-effect distillation. Water is heated and consequently transformed into steam, which purified water is recovered from. The steam is then cooled, and in this case, as with reverse osmosis, certain steam impurities with higher boiling points are removed. Vacuum systems, such as the pure steam generators WEMAC offers, ensure pharmaceutical processes where steam is incorporated are clean, as product sterility can be compromised due to impurities present in the steam.

In addition, and as Westmere argues, for the purpose of guaranteeing sterility, systems can be incorporated with the WEMAC pharmaceutical water systems that include Windows’ CIP systems which clean equipment without needing to be disassembled. These features include tanks for purified water and WFI which assist in closed circuit production processes by preventing the accumulation of microbes and impurities.

Regular water serves multiple purposes on a daily basis. It involves consuming, bathing, washing clothes, watering plants, and being a part of appliances: dish washer and washing machines. In some of the manufacturing industries, particularly agriculture, it is used for irrigation and as a coolant fluid where high grade purity isn’t a concern.

Pharmaceutical water is used for the purposes of the pharmaceutical, biotechnology and the adjacent industries. Some of the major uses of pharmaceutical water include the following:

Pharmaceutical products manufacturing: it is used as a raw material for the production of injections, oral medications and even topical creams. The water needs to be free of any impurities otherwise they might interact with the active pharmaceutical ingredients and cause severe adverse reactions for the patients.

Pharmaceutical equipment cleaning: water is used to clean the tools, equipment and even the production area.  It is also used to generate pure steam for the purpose of sterilization. This ensures that the production process is free of contamination.

Research and analysis: In the pharmaceutical and biotechnology industries, purified water is used in experiments as well as in other advanced processes like cell culture. The research results could be misleading and come to the wrong conclusions if impurities in water exist.

Supporting critical applications, WEMAC exports water systems to over 60 countries and regions. WEMAC’s multi-effect water distillers and pure water generation and storage systems ensure readily available high-purity water needed for production and research by pharmaceutical companies.

Local and national authorities monitor water sanitation to make sure that drinking water is not dangerous to human health. These regulations monitor various types of pollution such as microbial, metalliferous, and chemical, however, the guidelines are loose, as compared to those governing pharmaceutical water. As an example, unboiled and untreated water in the home plumbing system, and water that is mildly disinfected, has small concentrations of chlorine, or excessive minerals, is acceptable, as long as it does not pose a health threat to a reasonable portion of the population.  

The pharmaceutical industry is concerned with provision and control of Pharmaceutical Purified Water is the subject of careful and extensive international regulations. In addition to the GMP, it is controlled by the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), and the Chinese Pharmacopoeia (ChP). These documents describe in detail the levels of water and steam, production, evaluation, and storage of pharmaceutical water to be provided. For example, the United States Pharmacopeia has established a limit to the amount of endotoxins present in WFI. Endotoxins can induce fever and severe reactions in patients receiving certain types of injections, the presence of which is unacceptable in any capacity.

WEMAC undertakes operational compliance with these standards in all aspects of the company. Its product development meets the principals of GMP, and its automation control product development complies with GAMP. Also, WEMAC provides customers with validation documents like DQ, IQ, OQ, PQ, FAT, and SAT. These documents demonstrate that the water systems comply with regulatory standards and can be utilized in pharmaceutical systems.