High Purity Water Systemin Pharmaceutical Industry

Water is used widelyas a raw material in ingredient and as the solvent in formulating and manufacturing of pharmaceutical products and analytical reagents. It is one of the major commodities used by pharmaceutical industry. Pharmaceutical industries discovers, develops, produces and market drugs or pharmaceutical products. The raw water entering an industrial plant will often need treatment to meet the tight quality specifications for the specific needs of the industry. Here, there are different grades of water used for different purposes. Controlling the quality of water is a major concern and the pharmaceutical industry takes into consideration to provide resources for the same.

The water used in pharmaceutical industries is mainly of two types – Bulk water and Packaged water.Bulk water does not have any monograph and hence it is not mandatory for them to adhere strictly to the methods of production provided by the monograph. The categories included in bulk water is purified water, highly purified water, water for injection, water for Hemodialysis and pure steam. Packed water, as the name says, is produced and packed to prevent microbial contamination. Further, they are divided into various categories based on their application, packaging and shelf-life. Sterile purified water, sterile water for injection, Bacteriostatic water for injection, sterile water for irrigation and sterile water for inhalation are some few categories of packed water.

High purity water systems must be designed considering the type of product that has to be manufactured. Suppose the water has to be used for parenteral products, it is expected that the water will be used for injections. Distillation and Reverse Osmosis (RO) are the only acceptable methods as listed in the USP (United States Pharmacopeia) for producing water for injections. For bulk pharmaceutical and Biotechnological industries, Ultra Filtration (UF) method is used. Electrodeionization is another water treatment technology that can reach very high purity levels. Another consideration regarding design is the temperature of the High Purity Water System. It is said that hot systems (65-80 degree Celsius) are self- sanitizing. At last, the most important consideration is the level of quality desired.

When it comes to the validation of High Purity Water System in pharmaceutical industry, there are several aspects that should be considered. All the documentation must include a description of the system along with the print. If in case a system has no print, then it is usually considered as an objectionable condition. It’s based on a simple logic, if there is no print, then how can the system be validated? How will quality manager know where to sample? That’s the reason documentation with a description is important. In pharmaceutical industries, mostly the method used for manufacturing water for injection is Reverse Osmosis. Because these systems are cold, and the RO filters are not absolute, microbiological contamination is not unusual.

However, at the end it all depends on the purpose of the industry which will mark the methodology and the High Purity Water Systems and Services that needs to be installed.