Water is one of the most essential resources on earth. It has multiple uses across the globe, from consumption to agriculture, from manufacturing to electronics. Water is a vital element in the modern manufacturing industries that utilize water as an ingredient, for cleaning purposes, for diluting other strong liquids, a stabilizer and also used to transport things around. Modern industries have found innovative and judicious uses of water that were never imagined before. With a rise in demand for products and consumer goods, there was a simultaneous increase in the pressure on usable water sources.
Water is a critical component in the Pharmaceutical manufacturing industry. It is used as raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products and medical devices. However, the quality of water used for each of these purposes is different. For example, water used as a raw material has more stringent purity regulations as compared to water used for cleaning the factory/plant premises. Still, the quality of water for pharmaceutical use needs to comply with various international purity standards. Different grades of pure water are used to produce pharmaceutical products and medical devices. Manufacturers need to ensure the water treatment systems used to produce purified water are designed as per the required quality standards. A number of water purification processes are used to produce water that is up to the mark for use in pharmaceutical industries.
Let’s take a look at some of the most commonly used grades of water and the processes used to produce them:
1. Demineralized Water
Demineralization is the process of removal of certain minerals from feed water. In its natural state, water contains innumerable impurities and minerals that make it unfit for use with machinery. This impure water is called hard water. Hard water can be especially harmful to the internal parts of machines and systems employed in the pure water plant. It can severely corrode the metal parts and cause the rapid rusting of the parts. Hence, removing minerals from hard water is a very essential step in any purified water system. All minerals responsible for the hardness of water are eliminated and demineralized water is produced.
A process called Ion Exchange is used to remove the dissolved minerals and salts. The anion exchange resin removes minerals with a positive charge and a cation exchange resin removes minerals and salts with a negative charge. This process eliminates the impurities responsible for the hardness of water and makes it soft. Soft water is generally used in boilers to make steam. It is also used as feed water in other purification plants.
2. Purified Water
Purified water is highly purified water as compared to demineralized water. It is produced by passing demineralized water through another purification process for further filtration. Methods such as Reverse Osmosis or UV light purification are used to further purify water. When soft water passes through the fine filters in an RO membrane, the impurities are left behind in the filter and pure water comes out the other side. Additionally, the fine filters are capable of removing microbial contamination from water.
Purified water is used in pharmaceutical manufacturing units to produce water for injection or WFI, high purity water used in the formulation of parenteral (injectable) drugs. Multi-column distillations are used to produce purified water. A distillation plant converts the feed water into steam and then a condensation process is used to convert the steam into purified water.
Purified water needs to pass a number of purity tests ranging from pH, conductivity, hardness, heavy metal, microbial limit tests. Manufacturers need to ensure that the purified water used for the production of pharmaceutical products in their plant is compliant with regulations set in place by USFDA, EU, and ISI.
TSA Water System is a market leader in designing and manufacturing pure water systems in India. Our team of engineers makes sure that your pure water systems are compliant with the quality standards of various national and international agencies. Our in-depth experience enables us to offer expert advice to our clients and help them optimize their water systems for optimal purity.