Understanding Purified Water for Pharmaceutical Applications

Understanding Purified Water for Pharmaceutical Applications

Date 01 December 2023

The pharmaceutical sector, pure water is a key ingredient in the process formulation and production of APIs and pharmaceuticals.

What is purified water? Pharma?

Water purified is type of water, which is widely utilized as an excipient for the production of sterile and Apyrogenic drugs. It is typically made on site from potable water that must also meet strict quality requirements.

What are the advantages of purified Water?

Purified water applications in pharmaceuticals range from cleaning equipment to becoming one of the primary ingredients in various processes and products. A few of them are:

  • Producing oral and topical drugs
  • Granulation process is used in capsules and tablets
  • It is the water used to feed WFI (Water For Injection)
  • As the feed water for pharmaceutical grade steam that is clean and safe.
  • Cleaning solutions are prepared for preparation.

The Method to Create Purified Water in Pharma


At this point the water is conditioned to pass through media filters that remove suspended matter, such as mineral salts. This process is also known as ultrafiltration. After ultrafiltration, various additives are added to fulfill specific functions.

Certain of the methods of pre-treatment


A chemical called chlorine can be added into water to kill virus and bacteria.


Calcium and magnesium salts cause the water to become hard. Additives such as hydrogen peroxide and sodium hypochlorite are added to the water usually at temperatures of 80 degrees Celsius and transform the hard water into soft. Softening can also help during the process of electro-de-ionization.

Dosing System

Dosing involves three main goals. Anti-scalent dosing helps dissolve silica, sulfates and other precipitates present in the water, and could result in the clogging of the membranes of the filter. This is accomplished with the help of sodium hexametaphosphates. Following that, acids such as hydrochloric acid and acetic acids are added to remove carbon dioxide from the water. This is known as Dosing for pH adjustment. The sodium metabisulfite or SMBS is added to the water to remove the chlorine used in this process because it could be corrosive for the RO membranes inside the pipes.


Post Treatment Stage

Once the water has been treated using various additives, and making it move through filters that are multi-media The water is now in the post-treatment phase, where various processes are undertaken to ensure that the water is properly purified. This makes the water comply with the strict standards established to purify water set by various regulatory agencies.

There are a variety of processes used for purifying water. Based on the capacities of the plant and the final user's requirements the combination of any of the following procedures is employed to produce pure water that is pharma grade.

Reverse Osmosis

It is widely regarded as to be one of the most efficient methods to cleanse water. It is widely used in industries and pharmaceuticals where water is an important source of raw material and resource.

The word "osmosis" comes directly from the Greek word 'osmos' which is a reference to 'push'. When reverse osmosis is performed the natural flow of osmotic fluid of water is disrupted by semi-permeable membranes that force the water towards the dilute side.

The membranes that are used in reverse osmosis are typically comprised of cellulose acetate and have tiny pores that allow water to flow but encapsulating microorganisms. When a pump that is high-pressure applies to water and the water is then allowed to flow over the membranes it eliminates any contaminants that come into its path. It is crucial to make sure that the membranes utilized in the process require specific methods for sanitizing. Rinsing the membranes with hot water that is heated to 80 degrees Celsius removes microbial contamination. Acids like citric acid can be used to get rid of impurities inorganic that could compromise the quality of water that is passing across the membranes.

Reverse osmosis is effective in removing dyes, salts, sugars and other microorganisms and particles trihalomethanes, pesticides as well as volatile organic compounds. However, it is not able to eliminate the gases present in water, like carbon dioxide.


It is yet another method utilized by the industry of pharmaceuticals to produce water that is purified. It's comparatively less expensive than other methods and therefore is widely used by people.

The fundamental principle behind the de-ionization process relies on electrolysis and ion exchange. Its primary goal is to eliminate certain ions from waters and substitute them for desirable Ions.

Water is made up of different ions, or molecules with different charges as well as the atoms it contains. Ions that have positive charges are known as "cations," and ones that have negative charge are known as "anions". An EDI module is built with the help of ion exchange resin bed and separated by ion exchanging membranes that are basically high-surface electrodes with negative and positive charges. If an electrical current passes across the surface of water, at the right angle, it is charged positively and flows towards the anode that is negatively charged as the positively charged ions move towards the cathode charged positively, making the water unionized.

De-ionization is a powerful method to remove the dissolved particles like minerals, salts, and organic pollutants from the water.


It is another well-known method to make purified water. Distillation is the process that makes variations in the tensions of vapour (volatility) that are present in the water as well as impurities that remain within the water. The water is heated in a specially-designed multi-column distillation process. Vapours then are condensed into purified and sterile water.

One of the main uses for the purified water that is obtained by the distillation process can be Water for Injection (WFI). It is a kind of water that can be used to inject medications or other drugs directly into bloodstreams of patients.

Ultraviolet-induced Disinfection

UV disinfection can be a quick and affordable method of water purification. The drinking water gets exposed to ultraviolet radiation of certain wavelengths by using an ultraviolet lamp to kill pathogens, such as algae, viruses, bacteria and molds.

One of the most important uses of UV disinfection aside from the manufacturing of healthcare product is called Cleaning in Place (CIP), which is a process employed by the pharmaceutical sector. It is used to ensure that the equipment, vessels pipes, filters, and other equipment are safe to carry out various pharmaceutical processes.

In the end, pharmaceutical-grade purified water that meets specific prescriptions for pharmacopoeia can be obtained by a variety of methods. TSA has more than two decades of expertise in delivering optimal purified water solutions at the most affordable cost per liter. Our team is able to assist each step of the process from design to installation, through validation and after-sales service.