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How effective is your cleaning and/or sterilization process? Is it efficient and safe for your employees? If your company is like most biotechnologies and life sciences companies, you have probably validated these processes to provide a repeatable bacterial log reduction. But did you know your process may still have variability if you are one of the many using Sodium Hypochlorite? To understand and eliminate this variability from your process, it is important to understand the positives and negatives of this universally used chemical.
First produced in 1789, Sodium Hypochlorite, commonly known as bleach, was quickly embraced by the textile industry to remove the natural color of virgin cotton fibers as it is not pure white. Soon after its introduction, it was found that the same oxidative properties that enabled the textiles bleaching also made Sodium Hypochlorite an effective germicide based on its ability to destroy harmful microorganisms. As early as 1800, Sodium Hypochlorite was also being utilized to neutralize the odors associated with disease. Since its introduction, it has been said that no single chemical has played a more impactful role combating disease than Sodium Hypochlorite.
Sodium Hypochlorite consists of the formula NaOCl or NaClO, and it is effective in bleaching, cleaning, and deodorizing through oxidation and hydrolysis. Organic dirt exposed to Sodium Hypochlorite becomes water-soluble and non-volatile, which reduces its odor and facilitates its removal. In disinfection, Sodium Hypochlorite exhibits broad spectrum anti-microbial activity given its ability to breakdown the cell walls of bacteria, which results in a bacterial log reduction. This is why Sodium Hypochlorite, in various concentrations, is the most widely used solution for cleaning and sterilization in the biotechnologies and life sciences market segments. For example, if you are an engineer at a medical device or diagnostics manufacturer, there is a high likelihood you have validated its use for facility cleaning, bioreactor cleaning and sterilization, manufacturing-line flushing and cleaning, serving as an on-board reagent for instrument sterilization, and/or many other applications. It is effective and universally accepted as the paradigm for cleaning and sterilization.
You most likely already understand these benefits, and you have probably also faced some of the challenges that bleach poses to efficiency. What you may not know is that Sodium Hypochlorite is an extremely unstable solution that begins rapidly degrading immediately post manufacturing. Manufacturers of the various concentrations traditionally manufacture these products at a higher concentration than the requested or cited percentage. As an example, a 10% Sodium Hypochlorite solution may be manufactured at a 14 or 15% concentration with the intent of having the product received and used at 10%. The initial degradation of this product is steep but continues to degrade at a slower ongoing rate as well until it becomes ineffective. This equates to the need to consume the product quicker to ensure you are using it at as close to the intended concentration as possible, as this is what was used to validate your processes.
In addition, Sodium Hypochlorite can also equate to additional costs, chemical residuals, and employee safety hazards—which can also impact your processes.
The further from the date of manufacture that Sodium Hypochlorite is consumed, the more solution is needed in a process to represent the correct concentration. Costs can be improved by working with a supplier to proactively manage the supply chain to ensure you are being sent a product as close to the date of manufacture as possible.
The use of Sodium Hypochlorite within a manufacturing process can also add significant time and greatly impact speed to market if not used properly. Sodium Hypochlorite requires a significant volume of flushing and rinsing to ensure no residual chemical is left behind. Clean In Place (CIP) can take significant volumes of water, which not only costs money but also takes a lot of time, so this should be accounted for when engineering your process.
Manufacturing environments traditionally have inherent safety risks—this is no difference in biotechnology or life science manufacturing. Most companies have environmental, health, and safety initiatives to improve the overall safety and well-being of their associates. The use and handling of commercial strength concentrations (10-12%) of Sodium Hypochlorite can be counterintuitive to attaining those initiatives. Some would argue that it is safe because it has been around and used for centuries or that there are worse chemicals one can be exposed to, but Sodium Hypochlorite at a 10% concentration is a corrosive that could cause severe skin burns and eye damage. It is also considered to be very toxic to aquatic life with long-lasting effects. This is how Sodium Hypochlorite is classified by the Globally Harmonized System. Neither classification equates to a safe or environmentally sustainable product. For these reasons, engineering safety controls into your process is critical.
Nonetheless, Sodium Hypochlorite can be used efficiently and safely; its degrading properties can also be managed to eliminate process variability.
How does one do this? It starts with being aware of the positives and negatives, evaluating how you are using it, and engineering the proper controls into your process. It means working with your supplier to ensure their manufacturing aligns with your usage in order to eliminate the process variability caused by the degradation. It entails ensuring your process is robust enough to account for removing residuals through effectively flushing, rinsing, and cleaning after use. It requires establishing and enforcing that your employees are following OSHA standards for the safe handling of hazardous and toxic substances. These are all matters that can be overcome through knowledge and understanding, by asking yourself the questions posed here, and then working with a supplier to support deployment. Considering how the products manufactured in the biotechnologies and life science industries are used, we all owe it to the patients and healthcare professionals to eliminate this process variability.