Water for injection (WFI) is an essential product for pharmaceutical companies worldwide. It allows users to maintain the necessary purity and consistency while manufacturing drugs and similar products that are essential to many people’s lives. Why is water for injection important in the pharmaceutical industry, and how do professionals use it?
What Is Water for Injection?
Water for injection is the purest form of bulk water used in the pharmaceutical industry. Because it has extremely low levels of contaminants, it is a primary component of products that go directly into the bloodstream intravenously.
Types of Water for Injection
Pharmaceutical manufacturers use several kinds of WFI depending on their needs and goals.
1. USP WFI
USP WFI meets the standards set by the United States Pharmacopeia — an independent, science-driven nonprofit centered on building trust in the nation’s supply of safe, high-quality medicines. Suppliers must only produce USP WFI through distillation or reverse osmosis, and there are limits to the levels of total organic carbon and bacterial endotoxins permitted. USP WFI is a primary component used to make bacteriostatic or sterile WFI.
2. Bacteriostatic WFI
Bacteriostatic WFI contains a 0.9% benzyl alcohol additive as a preservative. It allows people to open the container and access the solution numerous times over the typical 28-day recommended usage period. The benzyl alcohol prevents bacterial growth.
3. Sterile WFI
Sterile water for injection is a single-use product that comes in disposable vials. Professionals must discard them immediately after heating or administering them to maintain sterility.
How Do Pharmaceutical Suppliers Produce Water for Injection?
There are several ways pharmaceutical enterprises’ supply chain partners can manufacture WFI to meet industrial needs.
1. Vapor Compression Distillation
This method — also known as thermocompression, vapor recompression, or thermal/mechanical vapor compression — heats evaporated water through centrifugal compression, with the system’s compressed steam as the primary source of warmth. Suppliers using vapor compression distillation for WFI production can operate their systems with simplified pretreatment methods, which typically include softened and dechlorinated feedwater.
Although vapor compression distillation is a hot-temperature process, users can switch between hot and ambient modes by opening or closing the distillate heat exchanger’s valve. The ambient setting periodically sanitizes the storage chamber and distribution channels with hot water from the distiller.
2. Multiple-Effect Distillation
Multiple-effect distillation utilizes high temperatures and normally includes a reverse-osmosis (RO) pretreatment step. It eliminates dissolved ions, bacteria, suspended solids, and viruses. Additionally, reverse osmosis prevents scale formation or distiller corrosion.
The RO system component contains a water softener, cartridge filter and carbon filter. These aspects collectively manage water hardness while removing particulate matter and chlorine.
Chemicals are the most common sanitation methods for multiple-effect distillation systems. Although some use hot water, this option is more expensive. Additionally, most distillers store this WFI hot in a tank, and it retains that high temperature when distributed to usage points.
Both distillation methods boil the water during the pretreatment step, and the collection of the resulting water vapor is free from impurities. Experts then collect it to put it through a condensation process that returns the water to a liquid.
3. Reverse Osmosis With Electrodeionization and Ultrafiltration
Suppliers can also make WFI reverse osmosis systems that combine electrodeionization or ultrafiltration methods. Although RO removes most dissolved ions, organics, and particulate matter, electrodeionization eliminates the rest. Ultrafiltration is the final step, which gets rid of bioburdens and endotoxins still present in the liquid.
These systems rely on both hot water and chemical disinfection for sanitation. Additionally, they generate and store WFI at ambient temperatures. Ultrafiltration and RO methods require the water to pass through semipermeable membranes that remove impurities. Regardless of the production method used, businesses producing WFI must take periodic samples by extracting the WFI through system valves.
People must receive specific training before gathering or testing the water since improper techniques could cause contamination or false positives. For example, they must flush the valve for several seconds before extracting a sample because this step will remove biofilms.
How Does the Pharmaceutical Industry Use Water for Injection?
Pharmaceutical plants need water for injection to satisfy numerous production requirements and remain competitive in a challenging and crowded market.
1. Producing Parenteral Drugs
The administration of parenteral drugs involves giving them to patients in ways other than by mouth. Two common options are injecting or infusing them to bypass the gastrointestinal tract. Medical professionals choose parenteral drugs when it is infeasible for patients to take the products orally or when they want to cause fast-acting therapeutic effects. Eyedrops, suppositories, patches, and topical formulas are other examples of parenteral drugs.
Parenteral drugs cause rapid effects because patients absorb them faster than medications taken by mouth. Clinicians sometimes choose this administration method for drugs with limited therapeutic windows.
Increased proportions reaching the intended site is also an advantage of parenteral drugs. Those taken orally pass through the liver first, resulting in smaller amounts of the product circulating through a patient’s system.
Additionally, if patients report gastrointestinal upset as a side effect of drugs taken by mouth, health care professionals may explore the possibility of giving them parenterally. This approach bypasses the digestive system, eliminating those undesired outcomes. Although WFI is the primary delivery vehicle for parenteral drugs, pharmaceutical companies also use it as a sterile dilutant for these medications.
Market researchers have found particular growth potential in the market for small-volume parenteral drugs packaged in containers smaller than 100 milliliters. Analysts expect the segment to show a 7.5% compound annual growth rate between 2023 and 2030. Additionally, they note that the increasing prevalence of chronic diseases and the ongoing need for intravenous medications in healthcare facilities are two factors driving the demand.
2. Cleaning Laboratory and Manufacturing Equipment
The pharmaceutical industry is tightly regulated, and people must carefully follow products to maintain safety and prevent product recalls. Workers use USP or sterile WFI to clean critical process equipment and containers used for parenteral drugs. This liquid effectively removes residues and is a suitable additive to dilute biocide concentrates.
From fluid-bed coaters to ribbon blenders, pharmaceutical plants rely on specialized equipment to create the consistent results stakeholders expect. Effective cleaning procedures are important for maintaining trust and showing the public that the brand prioritizes safety.
Additionally, since specific equipment designs can make cleaning more difficult to do thoroughly, those overseeing process control at pharmaceutical plants must adopt particular measures based on aspects such as the equipment, size, shape or the products made with the asset. For example, some pigmented pill coatings are difficult to remove because alkaline detergents or water may strip away the polymers while leaving a hazy discoloration.
Water for injection has the purity required to keep operations running while upholding safety standards. Integrating WFI into a thoughtful and specific cleaning process is an excellent way to maintain productivity while getting consistently excellent results.
3. Establishing Relationships With Reliable Suppliers
The pharmaceutical sector’s reliance on water for injection creates numerous opportunities for those purchasing it to find dependable sources to incorporate into their supply chains. MECO is an example of a leading enterprise meeting the biopharmaceutical industry’s WFI requirements.
Thousands of global businesses have installed MECO’s water-purification machines, and the equipment collectively produces more than 25 million gallons of pharmaceutical-grade liquid daily. Additionally, the machines can make purified water, which many pharmaceutical brands use as a pretreatment when making water for injection.
In addition to providing products such as water softeners, ultrafiltration products, and reverse osmosis systems to make WFI and meet other pharmaceutical needs, MECO’s team takes a problem-solving approach to the challenges with its engineering services. Specialists’ mastery of core concepts and their detail-oriented mindsets allow them to come up with the smartest solution for each challenge.
It also has a certified and factory-trained tech team that understands the critical need to minimize downtime. Whether a pharmaceutical business needs assistance with water-room management or an emergency machine failure, these technically oriented professionals are ready to help.
Pharmaceutical companies can optimize equipment investments by ensuring workers have the necessary knowledge to operate the equipment confidently while remaining productive. That is why MECO offers education and training support, helping equipment operators understand why these machines have technologies that shape the future of water purification.
Although WFI is vital, the providers of the equipment used to make it are equally important for supporting users’ business models and output. MECO has provided its customers with effective and efficient solutions for nine decades, demonstrating its commitment to excellence.
4. Facilitating Inhalable Therapies
Sterile water for injection is both a medication ingredient and a mechanism for therapeutic delivery. Inhalers are good examples of the first application since many medicines that go directly into the lungs include sterile WFI on the ingredient list.
Additionally, when many hospitals use ventilators or equipment that delivers low-flow oxygen therapy, healthcare decision-makers may establish a best practice of only inserting sterile WFI into the humidifier reservoirs. Similarly, patients with conditions such as cystic fibrosis often use nebulizers to encourage desired therapeutic outcomes. Physicians can prescribe sterile water for these treatments, making WFI a good solution if it comes in single-use containers.
5. Filtering the Blood During Renal Replacement Therapies
Hemofiltration is a renal replacement therapy most commonly used in intensive-care settings to treat conditions such as acute kidney injury or sepsis. Hemofilters are machines that push a patient’s blood through tubes and a semipermeable membrane that uses convection to remove waste products and water. The last stage returns the patient’s blood, along with replacement fluids.
This treatment is either continuous or intermittent, depending on a patient’s needs. In the latter cases, the procedure can last up to five hours. Additionally, health care providers may prescribe several times per week in outpatient centers.
WFI is an important part of successful hemofiltration treatments, and large-scale health care facilities need readily available supplies. Pharmaceutical brands with on-site machines to produce the liquid can provide it, creating an additional income stream.
6. Pioneering Medical Improvements
Numerous medical researchers are interested in options that can maintain productivity and increase safety. Some of their efforts center on inventive ways to use robots in repetitive but precise tasks. In one example, researchers examined efforts to use robots to mix intravenous compounded drugs. Their investigation included scrutinizing 33 studies to interpret the overall results.
One of the main takeaways was the robots increased production efficiency compared to manual measures. Even so, users must optimize these methods further, especially because they remain in the relatively early stages. Additionally, the advanced machines reduced the likelihood of preparation errors and failures. This example shows how WFI’s usefulness goes beyond the medications themselves and supports medical innovations that could forever improve how people receive care.
7. Enabling the Final Rise for Containers and Caps
Vessels and closures that touch vaccines and injectable medications receive final rinses with water for injection during production processes. Including WFI in that last step is also necessary for production lines making sterile products.
Successful pharmaceutical companies practice tight quality control, and leaders understand a single weak process link could compromise an entire product or system. Maintaining sterility during production is essential, but manufacturers must take similar care to uphold it when packaging the goods. Water for injection facilitates that last step, ensuring safety for the consumers who depend on those offerings.
8. Increasing the Availability of Generic Drugs
Analysts expect the water-for-injection market to achieve a value of more than $53 billion by the end of 2031. While pondering the reasons for the product’s continued demand, the researchers expected an increase in generic injectable drugs, including those that need bacteriostatic water for injection during production.
Additionally, the report’s authors said expiring patents for branded drugs create opportunities for the manufacturers of generic biosimilar products to seize. The data suggests generic parenteral drugs will become more common during the forecast period, particularly because those making them adhere to a faster process that does not require running clinical trials or toxicity studies.
Water for Injection: Essential to the Pharmaceutical Industry
Regardless of their size or year of establishment, pharmaceutical companies rely on water for injection for numerous internal processes that safeguard quality control. That commitment to high-quality results causes ripple effects by showing current and potential product users that businesses making life-changing drugs will follow best practices for safety and effectiveness, cementing their prominence.
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