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.
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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).
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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.
Purified water systems may be used for a variety of purposes in pharmaceutical manufacturing. For non-parenteral products it may be used in product formulation and final washing of process equipment and containers. In the manufacture of parenteral products it may be used in the initial washing of containers and to feed WFI systems.
To produce Purified Water, it is necessary to remove organic substances, high and medium molecular weight ions and bacteria / pyrogens to a level that meet the Eur.Ph, USP or JP requirements.
Purified Water is obtained by further purification of RO or Pre-Treated Water through Ion Exchange Deionisation/Demineralisation (DI), Electro Deionisation (EDI/CEDI), Ultra-Filtration and UV light treatment depending on the grade required.
Honeyman Water has built a market leading reputation on designing Purified Water systems that work for you, irrespective of the desired grade, capacity or application. Our water systems are designed and built to ensure:
Depending on the required grade, our typical Purified Water generation systems may consist of:
Whether your requirements are for a new Purified Water system, an upgrade of your current system or if you would like to discuss your Purified Water distribution loop replacement or installation, please contact us.
Our team of quality water experts will be glad to discuss your needs and provide a suitable and workable solution for you.
The company is the world’s best purified water generation system supplier. We are your one-stop shop for all needs. Our staff are highly-specialized and will help you find the product you need.