The pharmaceutical industry uses pure water in various ways. It can be employed in the formulation of non-parenteral products as well as the last washing of containers and process machinery. It may be employed in the initial washing of containers and the feeding of WFI systems during the production of parenteral goods. It is thus important to understand the purified water generation system in the pharmaceutical industry.
While there are several purified water generation processes, the main objective of all the operations are:
The term “purified water” is frequently used in pharmaceutical operations. Simply put, it is a type of pharmaceutical-grade water that is frequently employed as an excipient in the manufacturing of sterile and pyrogenic medications.
Pure water generation systems in pharma are usually designed keeping in mind the scope and scale of the plant and the end-use product specifications. One of the first steps in the purified water generation system in the pharmaceutical industry is the pre-treatment. Depending on the quality of the feed water and the requirement of the process, the pre-treatment stage may include the following processes:
An anti-oxidant such as chlorine is added to the water to eliminate bacteria and viruses.
Three key goals are achieved during the dosing process. To prevent the water’s silica, sulphates, and other precipitates from fouling the filter membranes, an anti-scalent dosage is used by adding sodium hexametaphosphates. After that, acids like acetic acid and hydrochloric acid are added to the water to remove carbon dioxide. This is called the pH correction dosage. The chlorine that was added during the chlorination process is additionally removed from the water by adding SMBS, or sodium metabisulfite, as chlorine could corrode the RO membranes in the pipes.
After the water is suitably pre-treated, different purified water generation systems in the pharmaceutical industry are undertaken for further purification.
Reverse osmosis is one of the most commonly used different purified water generation systems in the pharmaceutical industry and is considered one of the best methods for filtration.
Using semi-permeable membranes, reverse osmosis forces the water to the diluted side by interrupting the water’s normal osmotic flow. The reverse osmosis membranes are typically constructed of cellulose acetate and have incredibly small pores that allow water to pass through while trapping bacteria. The water rejects the impurities as it travels through the membranes when a high-pressure pump is used to force the water through. Additionally, it is crucial to make sure that the membranes utilised in the procedure need particular sanitization techniques. Microbial pollutants are removed from the membranes while they are being rinsed with hot water that is 80 degrees Celsius. Inorganic contaminants that could impair the quality of the water being carried through the membranes are removed using acids like citric acid.
RO is effective at removing salts, sugars, dyes, bacteria, other particles, microorganisms, trihalomethanes, pesticides, and volatile organic compounds. However, it cannot eliminate the dissolved gases in the water, such as carbon dioxide.
EDI is a popular and cost-effective method used for the manufacturing of high-purity water in pharma.
Ion exchange and electrolysis form the basis of the de-ionization process. Its major goal is to remove particular ions from the water and swap them out for more preferable ions.
Different ions, or molecules and atoms with various charges, can be found in water. The terms “cations” and “anions” are used to describe the positive and negative charges of ions, respectively. Ion-exchanging membranes, which are essentially high surface electrodes with positive and negative charges, are used to separate the ion exchange resin beds that are used to set up the EDI module. The positively charged cation flows toward the negatively charged anode, and the negatively charged anions move toward the positively charged cathode, causing the water to become de-ionized when an electric current is sent through it at a right angle.
De-ionization efficiently eliminates water-dissolved pollutants such as salts, minerals, and organic contaminants.
Distillation makes use of the volatility (difference in vapour pressures) of the water and contaminants that are suspended in it. In a multi-column distillation facility that has been properly developed, the water is boiled, and the vapours are condensed to obtain clean and sterile water.
Water for injection is one of the main applications for the purified water produced by the distillation process, as distillation is capable of removing endotoxins from the water. Water for injection (WFI) is a type of pharmaceutical water that is suitable for putting pharmaceuticals or treatments right into patients’ bloodstreams.
UV disinfection is one of the low-cost and quick methods of producing high-purity water. In this procedure, pathogens such as bacteria, viruses, algae, moulds, etc., are removed from the water by exposing it to UV radiation of particular wavelengths using a UV lamp.
Cleaning in Place (CIP), a technique used in the pharmaceutical industry to make sure the vessels, equipment, pipes, filters, and other paraphernalia are safe to be used for various pharma operations, is one of the primary applications of UV disinfection outside of the manufacture of healthcare products.
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There are different grades of water depending upon the application in pharmaceutical manufacturing. However, it is similar to the criticality of the process upon which different classes of cleanroom are based.
Raw water supply to a pharma manufacturing facility could be carried out from one of the sources, viz. municipal supply, groundwater, bore well, etc. However, numerous impurities often get filled in the said sources of raw water, thereby demanding removal and the right treatment before the water is ready to be taken into final utilization.
These impurities can be in the form of Suspended Solids, Colloidal Impurity, Microbial Impurity, Dissolved Impurity, Metallic Impurity, Gaseous Impurities or Organic Impurities. Therefore, a purified water purification & distribution system for pharmaceuticals undergoes minute, distinct processes to ensure that all impurities are thoroughly removed.
Thus, the path forward begins with Raw Water Analysis; a report on the same is attached below:
Understanding the different types of pharmaceutical water systems is essential for selecting the right solution for each specific need. The classification mentioned below will help us get a more holistic view of the pharmaceutical water purification system.
This is the primary step of a water purification system that involves a Chlorination (NaOCl) Dosing System. Chlorine being a strong oxidant, rapidly kills harmful viruses and bacteria.
Filtration is the most traditional method where water purification is undertaken through filter media. The media selected is based on the raw water parameters where the raw water analysis plays a vital role. These are also known as sand filters and are largely employed to get rid of total suspended solids (TSS), which are called multigrade filters (MGF). The water at the outlet of MGF is Potable Water.
At the beginning of the purification system, the oxidation properties of chlorine play a significant role in the removal of viruses and bacteria. However, as the purification system proceeds, the same oxidation properties pose a great threat to certain critical components like the RO membrane or the piping. The presence of free chlorine can often put these components at risk of scaling and salt precipitation.
In this method, the introduction of softener has a good effect on the ion exchange principle as it replaces calcium and magnesium ions (hard water) with Sodium Chloride Ions NaCl (Soft Water). Hence, the water available after softening is termed Soft Water.
UF is carried out by forcing water through a hollow fiber membrane which helps in reducing the Silt Density Index (SDI) of water. SDI also contributes to increasing the RO unit’s efficiency by eliminating the possibility of choking the RO membrane.
Dosing system is the addition of external agents in water to achieve certain objectives. The three types of this system are hereunder:
RO is a water purification process that forces water through a partially permeable membrane. This process involves a high-pressure pump which increases the pressure on water to pass through the membrane. As a result, the water gets divided into ‘permeate’ and ‘reject’. While the former has low salt dissolved content, the latter comprises high salt dissolved content. Based on the applications, the RO systems employed can be of 2 types: –
As the name suggests, EDI works on the principle of ion exchange. The construction of an EDI is very simple; it consists of 2 membranes, namely, the cathode and the anode. The primary difference between the 2 electrodes is that while cations get attracted to the cathode, the anions get attracted to the anode. This principle essentially leaves the water free of ions (deionized water).
UV light is used to disinfect various algae, molds, viruses, and other microorganisms. The UV light destroys the DNA of the microorganisms, thus preventing their further growth. UV is the final step in generating PW, and the output received is termed Pure Water.
WFI generation is based on the process of distillation. The PW generated by the purification process is passed through a Multi Column Distillation Plant (MCDP), which works on the principle of heat exchange. The PW undergoes a series of columns subjected to distillation by the repeated heating and cooling process. The output obtained at the end of MCDP is termed Water for Injection.
Every water purification and distribution system is unique, highly customized, and tailored to the raw water parameters, necessary end product parameters, and optimum design capacity. Therefore, the system must be neither over-designed nor under-designed to ensure maximum efficacy.
Fabtech’s Purified Water (PW) systems are engineered to transform any source water into high-quality purified water. Our Purified Water distribution system is designed with hygiene and efficiency at its core, ensuring a seamless flow of purified water via a closed-loop piping network throughout the entire facility.
Additionally, Fabtech offers comprehensive pharmaceutical solutions tailored to your manufacturing facility’s unique needs.