As one of the most commonly used resources, purified water production in pharma is an essential topic to discuss for anyone attempting to understand the industry. The purified water production system, especially for pharmaceuticals, is as varied as expansive. There are intricately designed machinery, complex chemical methods, advanced physiological processes, and extremely strict and stringent laws and regulations.
While the advent of technology has made it possible to make the process more efficient and less time-consuming, some issues continue to plague purified water production in pharma.
Global Water Shortage
According to the World Health Organization (WHO), half of the world’s population will be living in ‘water-stressed’ areas by 2025. Cities like Cape Town, South Africa, Sao Paolo, Brazil, and many others are already dealing with a massive water crisis. Even in India, 17% of the cities deal with water shortages of varying degrees. While there are a number of environmental and man-made factors that contributes to the situation, in a nutshell, it can be summed up into explosive demand and lack of adequate supply.
In such a scenario, an industry like pharmaceutical that needs a heavy amount of water for its day-to-day operations may find it difficult to maintain a consistent supply channel.
Feed Water Quality
When it comes to purified water production in pharma, the mere availability of water does not suffice. Pharmaceutical processes need a consistent quality of ‘feed water’ to keep the operations running. The seasonal changes in the turbidity, flow, and chemistry of the feed water which can seriously contaminate the process and have a severe impact on the end product. Such discrepancies can also result in large fines from authorities when the discharge regulations are not met. Designing a slightly oversized treatment system anticipating the variations and installing variable controls on chemical feed systems is a very efficient solution to fluctuations in the feed water.
Quality Requirements
Pharmaceutical products have a considerably significant use case; thus, the manufacturing process for the same is subjected to some of the most stringent laws and regulations in the business. While purified water production in pharma is designed to constantly churn out products that meet the highest standards of safety and quality, there are variables that can be difficult to control.
For example, total organic carbon (TOC), conductivity, microbial content, and endotoxins (for Water For Injection) are the compendial tests required for water in pharma. These tests can be run online or in laboratories. While testing for TOC, online and laboratory tests can have results as there is carbon everywhere, and there is always a possibility of intermediate steps of handling and testing contaminating the sample.
Complexity of Manufacturing Processes
Purified water production in pharma is a complex process. From the massive equipment used for pure water production to the many factors and calculations that are to be taken into account, it is an industry that needs several resources to function properly. Pure water production machines are intricately designed, and even a single leakage in a pipe or a minor malfunction in one of the many valves or even a slightly óff’chemical reagent can lead to serious ramifications. One of the best ways to ensure a successful operation is to hire the right talent for the team and keep the workforce updated about the current happening in the pharma world with periodic training sessions.
Although having bigger teams can give rise to human resource-related challenges, an optimized workforce solves more problems than it brings to the table.
Maintenance
Purified water production systems need a highly sanitized and controlled manufacturing environment. Simply having a working manufacturing design is not enough. It is also important to make sure that the equipment goes through periodic and thorough maintenance and checks. Constant use may result in the corrosion of certain metal parts, hindering their efficiency, while algae and other contaminants can easily form on the surface of valves and storage tanks. It is often a challenge to run constant inspections as it adds up to the downtime of the machinery. However, it is important to remember that in pharma, mistakes can be expensive, and not handling an issue immediately can ultimately lead to much bigger issues.
Expensive Measures
Pharma is an expensive business. The quality of pharma products is constantly under the scrutiny of regulatory bodies, and cutting corners is just not an option. Whether it is installing a water purification plant or maintaining the same, any operation in pharmaceutical is money intensive. Budgetary constraints are often the major reasons why many purified water manufacturers fail to sustain themselves in a constantly competitive market. Maintaining a constant flow of cash can be difficult, but it is absolutely crucial to make sure the plant stays in operation.
Waste Water Management
The pure water production process in pharmaceutical operations not only requires a large amount of water as a resource but it also generates a significant quantity of wastewater. Simply discharging the same into the nearest water body is not an option as it adds to the already grave problem of water pollution and water shortage.
The environmental impact of such practices has been widely discussed on global platforms, and modern industrialization continues to create tremendous pressure on natural resources. With environmental laws tightening across the globe, wastewater treatment has become indispensable for all businesses generating effluents. The process adds to increased cost and manpower but is unavoidable to ensure the sustenance of the planet.
Fortunately, technological advancements have come up with several wastewater management strategies that pharma manufacturing facilities can adopt based on their capacity and scope.
The above-mentioned common problems for water treatment plants can be solved by partnering with a competent pure water treatment plant manufacturer. TSA Water Systems have been designing, manufacturing, and installing pure water systems for more than a decade now. We help our clients evaluate their water treatment issues and provide ideas and resources to overcome them. Our efficient designs help protect our clients from losses, damaged reputations, and violations of regulations.
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- Guidelines to high purity water system validation
- Understanding purified water for pharma applications
