INTRODUCTION
A significant area of expertise for our water purification systems is the manufacture of pharmaceutical-grade water. Ensuring compliance with numerous significant Pharmacopeia regulations, we produce water using highly developed methods under the direction and supervision of proficient water purification specialists, producing approximately 25 million gallons of pharmaceutical-grade water on a daily average. The production of Water for Injection (WFI) and Purified Water (PW) at this level meets the ongoing needs of the pharmaceutical and biotechnology sectors.
What is water for injection?
WFI, also known as water for injection, is a type of solvent used to dilute other drugs or solutions that are going to be injected into the body. It can only contain very small amounts of biological or chemical substances that prevent the growth of bacteria or other microorganisms. Water for Injection (WFI) is used as a pharmaceutical vehicle for parenteral preparations, which are medications administered intravenously, as well as a fluid replenishment agent following the administration of an appropriate solute. WFI water can also be utilized for various ophthalmic (eye health) goods and inhalation drugs (diffused directly into the lungs).
Three distinct manufacturing techniques can be used to produce water for injection: membrane-based systems, vapor compression distillation, and multiple effect distillation. High-temperature (over 80° Celsius) settings and continuously flowing water systems are typically used in WFI systems. By using an increased temperature, the water is kept free of microbiological development.
Methods of producing WFI
There are three most common systems used in the production of WFI water. All of these include water softening and carbon filtration as a means of scale control and dechlorination of the feed water source.
Reverse Osmosis with or without EDI and Multiple Effect (ME) Distillation:
Worldwide, multiple effect distillation has been the most often utilized technique. Larger capacity systems usually have more effects to lower the energy input to the system because energy expenditures in multiple effect systems might be considerable. Because smaller capacity systems might only have three to five effects, the final user will pay less in capital expenses. Reverse osmosis (RO) is typically used as a minimum pretreat for feed water in multiple effect distillation (which uses higher temperatures) in order to remove dissolved ions that could otherwise encourage scale or distiller corrosion. The RO unit efficiently eliminates suspended particulates, germs, viruses, and dissolved ions. A minimum pretreatment system for the RO unit typically consists of cartridge, carbon, and water softening filtering. This facilitates the removal of particulate matter, chlorine, and hardness. It is customary to store water in an intermediate storage tank with a feed water pump due to the working pressures of both RO and ME. Some pretreatment systems need to have chemical cleaning done on a regular basis. Systems for sanitation using hot water can also be employed, although they come with higher initial and ongoing expenses. Most of the ME Water from still-generated WFI systems is heated and delivered to all points of use via a hot tank.
Reverse Osmosis / Electrodeionization (EDI)/ Ultrafiltration:
Reverse osmosis combined with the proper pretreatment, deionization, and ultrafiltration has been employed in various system designs. The use of UV light, second pass RO, membrane degasification, and hot water sanitization of all components downstream of the disinfectant removal stage are examples of modifications to the fundamentals of the RO/EDI/UF system. The carbon filter removes chlorine, while the softener removes hardness, much like multiple effect distillation. Most of the dissolved ions, organics, and particulate debris are eliminated via reverse osmosis. Electrodeionization is used to remove the majority of the leftover dissolved ions. To get rid of any last remnants of endotoxin and bioburden in the water, ultrafiltration is employed.
The system is usually capable of chemical cleaning and sanitization and is biogrowth controllable through hot water sanitization. Taking into account the rinsing and backwashing of the carbon tank, softeners, and rejects from the RO and EDI, the product water recovery rate is approximately 70%. Since the WFI is produced at room temperature, water is normally stored there as well. While some systems undergo periodic chemical cleaning and sanitization, others undergo periodic hot water sanitization. Before feeding the storage tank, certain generating systems are heated to self-sanitizing temperatures and kept there. Additionally, ozone can be used to continuously sanitize the WFI in the storage tank; however, WFI that has been ozonated is not transmitted to the Points of Use. It is destroyed by ultraviolet light before it is distributed.
VC & RO Technology
Vapor Compression (VC) Distillation: Because VC stills do not run at the same temperature as Multiple Effect stills, they are less prone to corrosion and scale. As a result, they can function without reverse osmosis on a reduced pretreatment system (usually softened, dechlorinated feedwater). Both ambient (~10–12°C above feed water temperature) and hot (80°C) temperatures can be produced by Vapor Compression stills. By opening and shutting the valve around the distillate heat exchanger(s), the distiller can be switched between the ambient mode and hot production. One of the main benefits of this system is the ambient (cold) VC still, which may regularly disinfect the distribution and storage system using hot water from the distiller. A background VC Still is better than one that generates WFI hot because it recovers more heat and uses less plant steam to run.
The fact that any leak in the evaporator will show up as high conductivity at the beginning is another advantage of VC distillation. This is because leakage moves from the distilled water side of the heat transfer surface to the feed water side (instead of the other way around) since the distilled water is processed at a higher pressure than the feed water. The feed water in a membrane-based system is always under more pressure than the product water, and any compromise to the integrity of the EDI or any of the membrane systems will have an adverse effect on the water quality. In the past, the compressor—a mechanical part required for the system's correct operation—has drawn criticism for vapor compression systems.
But because of recent developments and diagnostics, these compressors are now incredibly dependable, and maintenance can typically be completed in a few hours, if necessary.
Conclusion
Water for injection is an essential element in the biopharmaceutical manufacturing process. Many production methods can be implemented based on a number of factors, including capacity, existing infrastructure, risk, reliability and energy efficiency requirements for each facility. At Sterinox Systems, we’ll provide you with more information regarding our machines. Get the best quote Sterinox Systems.