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.
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.
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.
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.
For the best pharma producers out there, the best-in-class purified water generation and distribution systems must be guaranteed. With validation, FAT, and test facilities, every system at TSA complies with US FDA 21 CFR part 11 and GAMP 5. Additionally, your operations are assured to be frictionless with the provision of plant spares and operating and maintenance contracts.