Filtered water is a requirement for drinking supplies, food processing plants, so it’s no surprise it’s of the utmost importance for the pharmaceutical industry. Without a high-quality water filtration system in place, contaminants in the water can alter the lifesaving medications and solutions we depend on.
Pharmaceutical water, known as ultra-pure water, has been purified to filter and sanitize according to guidelines set by pharmacopeias, the authority that sets industry standards in a specific country or region. Companies must follow the water filtration guidelines set by the applicable pharmacopeias for the markets they are selling to. Whether used as an excipient in formulations, a cleaning agent or a product diluent, all agree the water must be free of chemical, microbial and endotoxin contamination.
The key to ensuring regulations are met, is the water distribution system itself. USP, the United States Pharmacopeia, has detailed guidelines for how to construct and install the system according to requirements. Critical to quality, the system must include a monitoring program made up sensors or automated instruments. Often, data loggers are installed to document and monitoring operating procedures such as flow rate and pressure drop, which directly affect microbial control.
The USP advises the water distribution system to allow for continuous flow of water. By recirculating water through the pipes, the system is easier to maintain. But recirculating the water isn’t enough; the pumps should be designed to deliver a turbulent flow. The irregular fluctuations not only provide a means for thoroughly distributing heat and chemical sanitants, but also to hinder the growth of biofilms responsible for producing bacteria in the water.
To control the growth of bacteria is the water distribution system, either thermal or chemical sanitation practices must be applied. Thermal approach recirculates hot water and steam at temperatures of at least 80 °F, although, temperatures of 65 °F has also shown to be effective in insulted systems. The thermal method requires a heat distribution study to validate sanitation temperatures are achieved throughout the system.
Pharmaceutical water is not only a requirement in the life sciences industry, but microelectronics, power generation and specialty applications as well. No matter the industry, MadgeTech offers data logging solutions for water treatment systems. The PRTemp1000D can record differential pressure and temperature simultaneously, providing validation that pressure and temperature requirements are being met. To monitor the 4-20mA output, the Process101A can directly connect to flow meters.
To view all the data logging options for water treatment applications, click here.