The design and maintenance of WFI water systems directly impacts patients’ health and safety. Water for injection, or WFI, requires exceptional purity standards to ensure it is sterile. A poorly designed water system can introduce contaminants into this water, potentially leading to very serious complications for patients. How does water system design impact patients and how can designers ensure safety?
Applications for Water in Pharmaceuticals
The pharmaceutical industry relies heavily on carefully filtered and purified water. It isn’t just used for drinking, either. Water has many applications in the pharmaceutical industry.
For example, water for injection is an ultra-high purity variety of water used in injected solutions, such as medications. In fact, WFI is included on the World Health Organization’s List of Essential Medicines, an index of pharmaceutical items that are vital to public health. Water for injection is considered sterile, so it can also be used for rinsing or cleaning certain items.
In addition to WFI, the U.S. FDA recognizes several other types of pharmaceutical water. These include non-potable water, drinking water, bacteriostatic water for injection and a few different types of sterile water. Non-potable water is any water that is not safe for human consumption. As a general rule, once water is used for something, it becomes non-potable, at least until properly filtered and purified.
Specially-treated water may be used as a component in pharmaceutical products or as a product itself for applications like cleaning and surgical procedures. Any type of water besides non-potable water requires careful inspection to ensure that it meets standards for sterilization and safety. Water purification systems are instrumental in ensuring patient safety. Otherwise, patients are at risk of serious side effects and illnesses.
The Risks of Water Contamination
What can happen if water that is meant to be sterile is contaminated in the manufacturing or treatment process? Impurities in pharmaceutical-grade water can pose serious health hazards for patients. In fact, contaminated water can even be life-threatening.
For example, water for injection needs to be isotonic to be safe for injection. When water is isotonic, it has the same osmotic pressure as the solution it is being injected into, in this case the human body. If WFI is not isotonic, it can cause red blood cells to shrink and break down as the body destroys the cells prematurely. This is a condition known as hemolysis, which has many possible causes but can be very severe, even leading to kidney failure.
Contaminated water can have many other serious side effects, as well, whether in surgical settings, in an injection, in a drug or in a hospital or care facility. Other possible side effects include infections and the spread of waterborne diseases, fungi, bacteria and other pathogens. In pharmaceutical manufacturing, contaminated water can even threaten the integrity, safety and effectiveness of drugs and solutions.
How WFI Water Systems Prevent Contamination
Preventing water contamination and its related side effects relies on highly effective water purification systems. The particular purification methods used vary depending on the desired type of water. For example, water for injection typically uses one of two treatment methods: multiple effect distillation (MED) and vapor compression distillation (VCD).
In addition to the actual purity of the water, the way it is handled and distributed also impacts health outcomes. As soon as any type of contamination enters the system, the water can no longer be considered water for injection, ultra-pure or otherwise sterile. So, WFI water systems have to be designed in a way that maintains the integrity and purity of the water.
Luckily, pharmaceutical manufacturers have access to advanced technology today that allows them to ensure a high level of water purity. New purification methods are always being developed, as well. For example, some purification systems use centrifugal force to extract contaminants by forcing water to flow in a cyclone-like motion. Manufacturers can also use filters, chemical water treatments and physical water treatments to remove contaminants.
The Importance of Equipment Maintenance
The mechanical equipment used to distribute and process pharmaceutical water can run into a few key issues. For example, equipment can develop microbial growth as well as leaks, both of which introduce contaminants into the water. These issues can have many causes, including water build-up, structural degradation, seal failure and poor cleanliness.
Maintenance of WFI water systems plays a big role in preventing microbial growth and leaks. Water systems need to be carefully and regularly sanitized and inspected. Exit and entry points from the system require special attention since these areas are the most likely sources of outside contamination.
Inspections should also include analyzing the whole system for any signs of leaks or failing seals. Welds are particularly important points to pay attention to. If a weld begins degrading or otherwise failing, it can cause leaks and also risk releasing toxins from the metal into the water.
Tips for Water System Design
Unfortunately, even with the best maintenance, any WFI water system can run into contamination issues if it is not well-designed from the start. There is no one perfect water system design since every system has different needs, but a few key principles can help.
For instance, drainage is vital to the success of a water system. The alignment of every pipe and component should be factored into the drainage design. Poor drainage can often result in water build-up, which leads to microbial contamination. Additionally, an ineffective drainage design can also cause poor system efficiency, leading to sub-par performance and higher power demands.
WFI Water system designers also need to consider the type of materials the system will be made with. On a basic level, pipes should always be made of non-toxic materials that won’t degrade from prolonged exposure to water. For example, to ensure safe plumbing, designers can stick to copper pipes and lead-free fixtures and joints. Other materials that are good for water system applications include stainless steel, the thermoplastic polymer PTFE, and the synthetic rubber EPDM.
Any coatings and sealants used in the water system design can also impact safety and effectiveness. Coatings and sealants aren’t always bad. They can actually improve durability and prevent degradation when used and selected properly. Opting for a high-quality coating for a water system’s pipes can help prevent maintenance issues and combat microbial and bacterial risks. However, designers do need to carefully verify that any coatings or sealants they choose will not compromise the purity of the water.
Ensuring a Safe WFI Water System
Patient safety relies on effective WFI water systems in pharmaceutical manufacturing and distribution. Contamination in WFI and other types of sterile water can lead to serious side effects, such as hemolysis, kidney failure and infections. By taking steps to ensure that water systems are completely clear of toxins and contamination, WFI water system designs help protect patients and ensure positive healthcare outcomes.
Emily Newton is a technology and industrial journalist. She is also the Editor in Chief of Revolutionized. She has over five years covering stories about warehousing, logistics and distribution.