Pure water is used for formulation, mixing, diluting and even as a cleaning agent in the pharmaceutical industry. However, the grade of water varies as per the requirements of the end product. Some pharmaceutical drugs and medical devices may need water to adhere to some critical quality standards, while some others may have less stringent quality requirements. Water for Injection (WFI) is water that is used in the manufacture of parenteral (injectable) drugs whose solvent is water. The United States Pharmacopeia (USP)) defines this as highly purified water containing less than 10 CFU/100 ml of Aerobic bacteria.
Pharmaceutical companies can adopt any of the two means defined by the USP to produce WFI; either distillation or reverse osmosis. Before producing WFI water companies need to ensure that the feed water is pure enough. If not, Pre-treated water is used to make WFI. Pre-treatment of water aims to remove various ionic and organic compounds. This is achieved by having the water go through multiple filtration processes.
Below we have listed some techniques adopted by pharmaceutical manufacturers to produce WFI for their processes:
1. Dechlorination – This refers to the removal of chlorine from the water. One of the methods to perform dechlorination is running the water through activated carbon media. The carbon reacts with the free chlorine in the water to form hydrochloric acid and carbon monoxide/dioxide and effectively dechlorinates it.
2. Ion Removal – Using Ion removal involve utilizing one of the three methods i.e. membrane processes, ion exchange processes, and distillation processes. Manufacturers employ any one or a combination of these processes to produce WFI. The ion removal process is aimed at reducing the conductivity by removing unwanted ion and particles and if possible adding some desirable ions in the process.
3. Bacterial control techniques – One of the important factors that differentiate WFI water from pure water is strict bacterial control standards for WFI. Controlling bacteria involves taking care of both – the procedures and equipment. Equipment such as ultraviolet (UV) lights, ozone generation systems for the production of ozone, heating systems for thermal treatment, and chemical injection and recirculation systems should be integrated with the normal working of the pure water system used to produce WFI.
WFI water is also used as a cleaning agent for various equipment used to produce, distribute and store WFI. To produce WFI, feed water is passed through a series of processes to reduce conductivity and the level of organic compounds.
You need to make sure that your business uses the correct level of pure water to produce various Pharmaceutical products. To this end, you need to adopt the correct methods to purify water. TSA Water Systems is a market leader in providing pure water treatment systems to its clients. Clients leverage TSA’s in-depth knowledge about pure water systems to build water systems that are not only pure but also maintain its purity.
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Learn what is water for injection(WFI) in pharma.
