Water Purification System Challenges in the Pharmaceutical Industry

Water purification systems play an integral role in the manufacturing of pharmaceutical products. Therefore, it is important to know what type of water purification system your pharmaceutical company requires and what concerns your company may have when looking for the best fit.

In this article, we will cover the different types of water that are used in the pharmaceutical industry, the challenges faced when selecting the correct water purification process for you and how Vicol (Pty) Ltd can help your company overcome them.

The 8 types of water used in the pharmaceutical industry

There are several types and grades of water that are used in the pharmaceutical industry’s manufacturing processes. Each grade adheres to the strict guidelines and standards set out by the global pharmacopeia’s regulatory bodies, such as USP, SANS, SAHPRA, WHO, EP and ISPE.

These types and grades of water are:

  1. Non-potable water
    This type of water is of poor drinking quality and should not be consumed. However, it can still be used for many other purposes, depending on its quality, such as cleaning the interior or exterior of a factory, cooling systems, landscaping, irrigation, etc.
  1. Potable (drinkable) water
    This type of water is not used in general pharmaceutical manufacturing, as it contains a considerable number of solids, such as chlorides, sulphates and bicarbonates (Na, K, CA, and Mg). However, it can still be used for general drinking water, washing and the extraction of crude drugs, as well as the preparation of products for external use.
  1. USP purified water
    This type of water is utilised in the manufacturing and production of all medications containing water. This grade of water must meet all regulatory requirements for ionic and organic chemical purity and must be protected against microbial contamination during storage and transportation.
  1. USP water for injection (WFI)
    This type of water is used as a solvent in the production of parenteral medications and other preparations where endotoxin content must be controlled. Since endotoxins are created by microorganisms that tend to inhabit water, the equipment and procedures used in the water purification system, to store and distribute WFI, must be designed to minimise microbial contamination. This includes the removal of incoming endotoxins from the standing water.
  1. USP sterile water for injection
    This type of water must comply with the standards seen in the USP monographs for water for injection and should only be packaged in a single dose container, not more than 1-litre in size. The Total Organic Carbon (TOC) as per IP should be no more than 0.5 mg/litre. In contrast, the same limit of TOC for Water (500 PPB) in USP and BP.
  1. LUSP sterile water for inhalation
    This type of water is prepared using WFI grade processes, that has then been packaged in type 1 or type 2 glass containers and rendered sterile. Its intended use is for inhalators and in the preparation of inhalation solutions. As it carries less stringent specifications for bacterial endotoxins than sterile WFI, it is therefore not suitable for parenteral applications.
  1. USP bacteriostatic water for injection
    This type of water is used as a dilutant in parenteral products, mainly for multi-dosage medications requiring continuous contents withdrawal. It contains bacteriostatic (antimicrobial) agents and should always be packaged in single-dose containers or small multi-dose containers. These should be no larger than 5ml in size or in a multi-dose container no larger than 30ml.
  1. USP sterile water for irrigation
    This type of water is prepared using the same WFI grade procedures and has been packaged and rendered sterile. This water is commonly used when sterile water is required but does not have particulate specifications, which includes wherever pure water or WFI is specified. It is typically stored in sterile containers larger than 1 litre.

The challenges faced when selecting the right water purification system

When a pharmaceutical company is looking for a water purification system or water supplier, they are often unsure of what they need or what solutions will work best in their manufacturing process. This leads to companies purchasing limited or basic water purification systems that do not meet the pharmaceutical company’s requirements, which can escalate to compromising operational efficiency, which will, in turn, affect their operating costs and production quality.

One of the most significant concerns expressed by pharmaceutical manufacturers across the globe is Total Organic Carbon (TOC), which is a key indicator to test for in water purification processes. Additionally, in the production of pharmaceutical products, microbial contamination is a large concern, as any organics or bacteria can affect the quality of the water and, ultimately, your products.

Water contaminants can materialise in the following ways:

  1. Poor water purification system design
    It is important that pharmaceutical companies fully brief the water purification design team on the exact requirements needed for their manufacturing processes. Otherwise, what can end up happening is under-engineered systems are designed that do not meet the necessary water purification requirements set out by the USP, SANS, SAHPRA, WHO, EP and ISPE. These systems could also fail to include essential purification components, such as RO (Reverse Osmosis) filters, storage vessels, deionisation systems, UV technology and final filtration.
  1. Poor distribution and water storage tank design
    Water purification distribution systems are often constructed from stainless steel, if passivation is not performed to prevent corrosion of the stainless-steel pipes, possible contaminants from the pipes could enter the water. The same material is used in the design and creation of water storage tanks, however, if poorly fitted and not ventilated with hydrophobic air filters, it is possible for microbial contamination from the outside air to occur inside the tank.
  1. Inadequate storage and distribution design
    Storage and distribution systems that are poorly designed can lead to the establishment of microbial biofilms, which causes product contamination if not detected and removed quickly. Unfortunately, microbial colonisation is often difficult to detect because biofilms release contaminants slowly and randomly.
  1. Selecting the wrong testing procedure
    Sending water samples to outsourced labs for TOC count can increase the risk of potential human error, as well as false out-of-specification results. With industry advancements in technology and equipment, like an inline meter that can take the “human error” element out of the equation; providing you with more accurate and timely results.
  1. Variations in storage temperature
    Recirculating stainless steel systems are typically used to store pharmaceutical grade waters, however, polyvinylidene fluoride (PVDF) can be used when very low mineral content water is needed. Recirculating stainless steel systems offers the capacity to operate at temperatures of 10ºC to 80ºC. Depending on the grade of water being stored and the manufacturer-specific requirements, the distribution systems can operate as “cold” or “hot” systems with the desired temperature being maintained to ensure ongoing microbial stability.

Making the right choice for your pharmaceutical company

Understanding the potential risks of a poorly manufactured water purification system will help you make the right decision when choosing the best water purification system for your pharmaceutical company. At Vicol (Pty) Ltd, we work with many of the biggest and best pharmaceutical companies around the world. With over 20 years of industry experience, we know what having the right water purification system can do for your business.

Purification systems designed for growth

Planning for the future and its possibilities is, generally, something companies worldwide will do quite consistently, in terms of company growth, direction, pitfalls, etc. However, a big mistake that is often made by, both, manufacturers and water purification system designers, is focusing purely on today’s usage.

A water purification system should always be designed with the flexibility that is needed for future growth. Afterall, when your company grows, you will need a flexible water purification system that can handle all increases in usage without worrying whether you will need to halt all production to perform needed system upgrades.

At Vicol (Pty) Ltd, we continuously strive to provide custom-designed solutions that will not only suit our clients current water purification needs, but also keep in mind their future needs and growth potential. Over the years, we have been able to guarantee measurable results and, with our ability to quickly adapt to niche requests, we can accommodate these requirements with minimal impact on costs to our clients.

Understanding industry requirements and regulations

Water purification in the pharmaceutical industry has stringent regulations and demanding requirements that are frequently monitored and updated by the USP, SANS, SAHPRA, WHO, EP and ISPE. It is therefore vital that your water purification system meets these standards and are validated by these bodies, accordingly.

As with all pharmaceutical processes, validation and documentation of your water purification system is a must. If a water purification system manufacturer is not up to date with regulations or are unable to provide the relevant validations and documentation, then odds are the system created will not be up to code and can, potentially, cause serious manufacturing issues in the future.

At Vicol (Pty) Ltd, we are continuously studying changes in regulatory requirements, which may include revised guidelines and regulations. We are also able to provide our clients with a complete design solution that consider all regulatory demands, including:

  1. Plant and Process Design
  2. Turnkey Installations
  3. Commissioning and Operator Training
  4. Risk Assessment and HAZOP Studies
  5. Complete Documented Quality Control Plan for Each Part of the Process
  6. Complete Validation Documentation for Pharmaceutical Applications

European quality solutions, delivered to Africa by a South African company

Finding the right water purification solution for your pharmaceutical company may be a challenge, but with the right water purification partner, it can be a breeze. At Vicol (Pty) Ltd, we take extra care when considering your company’s requirements and, with over 20 years of industry experience, we can help find you a flexible water purification solution to suit your current and future needs.

As a South African-based company, we believe in delivering international quality services to the African pharmaceutical industry. We understand your company’s need to save money and time, as you grow your brand, which is why our services are focused on supporting that overall goal. We offer guaranteed results, affordable designs, effective implementation, experienced partners and, most importantly, accessible, localised and reliable support.

Contact us today at +27 (0) 11 315 1842 or visit us at www.vicol.co.za for more information on how we can help you design the perfect custom water purification solution today.