Water, water everywhere. But you can’t use most of it in a pharmaceutical operation. When producing drugs, vaccines or any other medical products, you want to maintain the highest sanitary standards possible. Else, you might be in hot water, drawing flak from regulatory authorities and also running the risk of causing adverse events in the people who trusted you by purchasing or using your products.

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Enter your purified water storage and distribution systems.

Water is one of the most essential resources in the pharmaceutical industry. Apart from the many processes that go into taking feed water and making it usable for pharmaceutical operations, it is also important to have adequate and efficient purified water storage and distribution systems that supply your entire facility.

Why You Need Specialized Purified Water Storage and Distribution Systems in Pharma

Water has the potential to attract contaminants that are airborne or may be introduced into the system through any of the several surfaces it comes into contact with, be it during generation, transfer, storage or distribution. As we’ve mentioned, pharmaceutical processes require Purified Water – water that is free of microbial and other contamination. This is why high purity water is usually produced on-site.

Purity is a challenge, sure, but another concern when it comes to purified water generation and distribution systems is the specific conditions under which the water must be delivered at a process water point. Each function at a pharma facility requires water at a specific pressure, temperature and flow to ensure the integrity of the chemical or biochemical reactions taking place. This is where the efficiency of your purified water distribution systems can make or break the success of your production lines.

There are many factors to consider when installing a purified water (PW) system. The type of water needed for pharmaceutical manufacturing is highly specific and delicate in nature. All the major pharmacopoeias of the world determine the specific properties of the water used in different processes, and the particulars are stringently enforced and scrutinised to ensure complete quality control. Thus, from operating at specified temperatures to the material used in your equipment’s contact surfaces, getting your purified water storage and distribution systems right can help you blow your competition right out of the water.

Understanding the Specifics of Purified Water Storage and Distribution Systems in Pharma

Main Components & Functions

A storage tank and a pump (or pumps) for circulation are the two primary components of a purified water storage and distribution system. The storage tank’s job is to offset spikes in water consumption. Circulation pumps are responsible for maintaining the necessary pressure in the system and guaranteeing turbulent flow in pipelines. The distribution system may have one or more circulation loops beginning and ending in the storage tank, depending on the quantity and location of consumption points.

Specific Operating Conditions & Requirements

The typical structure of a pharmaceutical water distribution system consists of a circulation loop, ensuring turbulent round-the-clock water motion. In the case of Purified Water (PW), the loop typically operates in a cold mode at temperatures between 15 and 25 °C. Water for Injection (WFI)is often kept heated at a temperature of more than 80 °C.

To reduce the possibility of bacterial growth in the system, UV units for water disinfection equipment are installed at the PW loop feed lines. In the pharmaceutical business, installed UV disinfection equipment must be totally drainable and without dead legs which can cause stagnation, leading to microbial contamination of the water.

Moreover, energy from the pump is often transferred to the water in the form of heat as constant circulation results in friction on the pipe walls. Therefore, in cold water loops, it is necessary to install a heat exchanger which protects against excessive temperature increases in the system. A unique sanitary design of shell-and-tube heat exchangers known as DTS (Double Tube Sheet) type heat exchangers is used in purified water distribution systems for this purpose in the pharmaceutical industry.

Finally, when it comes to WFI storage and distribution systems, you need to periodically sterilise them at a temperature of less than 121 °C. The WFI storage and distribution systems may also be sterilised using superheated water or pure steam.

Sanitization Procedures

So you’ve completed the design and installation stages of your water storage and distribution system. Hoping to put your feet up as the machines take over the work? If you don’t want to be in hot water, you probably shouldn’t do that. It is crucial to keep up the maintenance of your purified water distribution systems.

Purified water generation and distribution systems must undergo periodic sanitization procedures as recommended by regulatory authorities or as per commonly accepted good industry practices. Here are some of the different ways in which purified water storage and distribution systems are sanitised in pharmaceutical production facilities:

Chemical Sanitization:

Specific chemicals are used to clean out the interiors of the storage tanks and distribution pipes to eliminate contaminants and discourage pollutants from accumulating, and consequently compromising the output quality. However, it is also important to clean the traces of the chemicals used during sanitization so that they don’t interfere with the water purification processes. 

 Thermal Sanitization:

Thermal sanitization is also used as a standard operating procedure (SOP) for adequate maintenance of the storage and distribution networks. For thermal sanitization, the water is heated to high temperatures and circulated throughout the networks to eliminate microbial contamination. 

Sanitization with Ozone:

Using ozone for sanitization has become increasingly common as it is effective at killing yeasts, moulds, bacteria, viruses, and biofilms. It is simple to produce on-site, fairly effective and most importantly, leaves no residual effects after disinfection.

You will get efficient and thoughtful service from ShekeSaisi.

Considering the several complexities and complications of the pharma business, it’s not surprising that you might sometimes feel like you’re treading uncharted waters. That’s exactly why you need experts to guide you every step of the way. An effective support team will help you realise that it’s possible to have a state-of-the-art facility without spending money like water. All it takes is a commitment to quality and safety, and a refusal to give in to the obstacles that crop up in the pharma business.

At TSA, all contact parts of our storage and distribution systems are electropolished to less than 0.4 RA microns, and the joints are orbitally welded using a video borescope. Our Purified Water systems have a sleek mechanical design made of stainless steel 316L. Considering your specific requirements, tanks can be made in a simple or jacketed style. And most importantly, the pumps can operate optimally even at peak loads, meaning you never have to worry if your equipment can keep up with the dynamic production demands of your business.

The Importance of Purified Water in the Pharmaceutical Industry

Purified water plays a critical role in the pharmaceutical industry, as it is used for various purposes, including the production of pharmaceutical ingredients, reconstitution of powders and liquids, and synthesis of drugs. Pharmaceutical water systems must provide water that is as pure as possible to keep impurities and other contaminants away.

They require purified water systems, as they need to provide products of the desired quality. Here are various ways purified water is essential to the pharmaceutical industry.

Reconstitution

Purified water is also used to reconstitute powders, as it helps to ensure that the final product is free from contaminants and is of the appropriate strength. Reconstitution is the process ofadding a solvent to an ingredient or a medication that is in powder form.

It dissolves the ingredient or the drug to keep it suspended in a solution. The solution may act as an ingredient in the final product’s consecutive formulation and development or the medication itself.

Purified water is free from impurities, such as dissolved minerals, which could affect the drug’s efficacy. Additionally, pure water ensures that the final product is at the correct strength, as impurities in the water could dilute the final product and affect its potency.

Pharmaceutical Ingredients

In some pharmaceutical production processes, water may be a required ingredient. Ordinary water, including drinking water, is often full of trace impurities and contaminants, making it unsuitable as a pharmaceutical ingredient. Therefore, a water purification system is required to provide clean water free from impurities.

Synthesis

In the synthesis of drugs, purified water is used to dissolve and mix ingredients and to clean equipment, ensuring the purity and consistency of the final product. Synthesis is creating a new chemical compound bycombining two or more compounds. While the process may not always require water as an ingredient, water may still be necessary for the reaction. Impurities in the water can lead tosignificant synthesis problems, thus the need to eliminate impurities as much as possible.

Cleaning

Pharmaceutical equipment requires thorough cleaning before and during deployments. While cleaning will help eliminate most of the potential contaminants, it may also add some contaminants to the equipment in the form of tiny impurities.

A purified water system provides pharmaceuticals with reliable water sources that are chemically clean and ready to be used in preparation and washing. Some ingredients may also require cleaning, needing close attention and care to avoid contaminating them and affecting the final product.

Testing and Analysis

Testing and analysis are critical steps in the production of drugs, as it ensures that the final product meets the appropriate standards for safety and efficacy. It occurs at every stage of the pharmaceutical production process, and it helps understand any contraindications or side effects of the product. Purified water is used in testing and analysis to ensure that the samples are free from impurities, such as bacteria and dissolved minerals, that could potentially skew the analysis results.

Access Continuous Purified Water for Your Business by Installing a Water Purification System

Purified water is essential for the production, testing, and analysis of drugs in the pharmaceutical industry. Purified water ensures that medicines are free from contaminants and meet the appropriate standards for safety and effectiveness.

At Ultra Pure Water technologies, we specialize in selling, installing, maintaining, and servicing commercial and medical water pre-treatment and filtration systems. We offer various water purification solutions, such as commercial water softener models, reverse osmosis systems, and deionization.Contact us today for consultation and installation of industrial water purification systems for more streamlined production processes.

Categorised in: Industrial Water Purification

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