Water is a crucial resource for our survival as a species, but over the centuries, our use of water has become so much more complex and integral to various industries across the world. Without access to purified water, much of the food, beverage, manufacturing, agricultural and pharmaceutical sectors are left inoperable. Fortunately, water purification companies provide a wide range of water products and purification processes to suit the needs of any industry.
The pharmaceutical industry, in particular, is heavily dependent on a reliable, safe and sustainable supply of purified water. One of the main processes required by the pharmaceutical industry is water for injection (WFI) systems that provide some of the highest quality water available on the planet. The main difference between WFI and other purification processes is that WFI produces water that meets much stricter regulatory controls and standards.
When it comes to WFI, pharmaceutical companies require a deeper removal of unwanted particulates and compounds from their water sources. Even though many of the bacteria, organic compounds and minerals present in the municipal supply are not harmful to humans – in fact, many are beneficial to us – can be detrimental to the very delicate manufacturing processes conducted by pharmaceutical companies. As WFI is used in the preparation of parenthal products such as IV’s and injectables an extremely low bacterial and endotoxin (cellular wall of dead bacteria cells) levels are stringently enforced to ensure patient safety.
That is why we have even more sophisticated water purification processes in order to generate, WFI, for the pharmaceutical industry. WFI generation processes produce water that can meet the most rigorous and toughest quality control. Water purification partners help pharmaceutical companies manufacture the best possible quality drugs and medicines. However, that also requires careful transportation and storage to ensure it remains within required specifications after it goes through several purification processes.
Not every manufacturing operation in the pharmaceutical sector requires WFI-level purity from their water, but when they do, it is absolutely critical that their water purification partners meet their exacting standards. WFI goes through many of the same processes as other Purified Waters and waters for consumption, however it will always include additional processes such as Ultrafiltration and/or Ultraviolet radiation to ensure compliance with WFI standards.
Let us take a look at some of what is required of water purification systems and processes to reach the purity level of WFI for use in the pharmaceutical industry:
Deionisation Techniques
The process of dissolved ionic and molecular removal is critical in WFI purification processes as it removes a variety of unwanted particulates, organic compounds, minerals and living organisms from the water source. Ion rejection allows the water to pass through some kind of membrane or filtration system and leave behind unwanted particulates and compounds. This is done using one of three common deionisation techniques: membrane systems, distillation methods and ion exchange processes.
Ultrafiltration and reverse osmosis membranes have revolutionised the way we purify water for the preparation of WFI for the pharmaceutical industry. They – in conjunction with other technologies – have made the deionisation and purification of water a more precise and effective process. Water purification companies rely on these systems to ensure they can reach the purity levels and high standards requirement for pharmaceutical manufacturing.
Dechlorination Processes
Prior to the processes of double-pass reverse osmosis, Ultrafiltration or other distillation techniques required in preparing WFI the feed water is dechlorinated. This refers to the removal of chlorine from the original potable water source. Specific methods, such as UV radiation, reducing agents like sodium metabisulfite and carbon filtration, are used to remove any chlorine remnants that could damage the sensitive membrane processes used to generate water for Pharmaceutical use.
The most common dechlorination strategy in the industry is to run that water through an activated carbon filtration system that attaches to and reacts with the chlorine molecules. This reaction forms carbon monoxide or hydrochloric acid that are easy to remove from the water source and effectively removes all chlorine. Additionally, UV rays can be used for TOC reduction and for sterilisation during pre-treatment steps prior to the main purification processes.
Bacteria Control and Removal
Pharmaceutical water for injection is of the highest quality, but can still be susceptible to a variety of common bacteria that thrive in water. In order to ensure that the water is microbially free as it was going through the WFI purification processes, that water must be free of any unwanted bacteria. Bacterium build-up will often occur during the processing, storage or delivery phases of producing WFI for pharmaceutical use.
There are many antibacterial techniques used by water purification companies that include: UV lights, ozone generation, heating, recirculation and chemical injection systems. UV lights are a popular form of bacteria control and provide an effective, non-invasive, and non-chemical means of removing unwanted bacteria from purified water at any stage in the production, storage, and delivery of water for injection.
WFI Storage and Distribution
As we have mentioned, storage and distribution are crucial to the success of purification processes for WFI. It does not matter if you can purify the highest quality water on the planet; if you cannot keep that water microbially stable, safe, and uncontaminated during the storage and distribution process. This is where pharmaceutical company owners and managers need to ensure they select the right partner for their water purification needs.
Water purification businesses will have a rigorous and precise process for creating WFI-level water and delivering that product on time and consistently. However, it is important that they have an equally detailed procedure for what they do with your water between their purification facility and your manufacturing facility. Choosing the right water purification partner could be the difference between world-class pharmaceuticals and ones that cannot pass strict regulatory requirements.
Conclusion
Ensuring that the water used in your pharmaceutical operations is up to standard and meets all industry regulations can become a difficult task without the right supplier. Vicol offers industry-leading custom turnkey water purification solutions for the global pharmaceutical industry, including custom designs, manufacturing, system installation and maintenance. For more information about how our incredible water purification solutions can help support your business, contact Vicol today.
