A flood of warning letters from the FDA (U.S. Food and Drug Administration) on water system suitability could pull the plug on the production of food, beverage, cosmetic, nutraceutical, and over-the-counter (OTC) or pharmaceutical products if companies are not conducting total organic carbon (TOC) water testing analysis on a regular basis, reports NJ Labs (New Brunswick, NJ).
TOC water testing analysis is frequently used as a technique for determining water purity. Once tested, the level of organic carbon in the water determines the level of impurities. Different industries must adhere to different standards for acceptable water purity in final goods and water utilized in manufacturing.
Some FDA warning letters that have been issued call out companies that have failed to validate that their water systems consistently produced water suitable for its intended use. Some letters state that certain companies use water from their water systems as a component to manufacture its drug product, but have not established that the water system is adequately designed, controlled, maintained, and monitored to ensure that it is consistently producing water for its intended use.
Companies who fail to correct their water system can face regulatory or legal action including seizures or an injunction, NJ Labs noted. Unresolved violations may also prevent other federal agencies from awarding contracts. The FDA can also withhold the issuance of export certificates or the approval of new applications.
“Real-time water quality insights can help manufacturers mitigate risk of product contamination, minimize product loss, costly fines and decrease operating costs,” said Sandra Lee, CEO of NJ Labs who works with cosmetic, nutraceutical and pharmaceutical manufacturers who need TOC analysis. “The ability to quickly identify problems using NJ Lab’s TOC water testing analysis, allows manufacturers to take immediate corrective action before damages are incurred, thereby meeting product quality demands and avoiding impacts to both brand integrity and the bottom line.”
Testing organic load variations in real-time provides manufacturers with a data-driven, decision-making tool for quality control, process monitoring and regulatory compliance. TOC water testing analysis is a simple method to measure water quality and provide insights into all organics present—from ingredient to production to wastewater processes. If leaks or impurities are detected, quick adjustments can be made to help prevent contamination, minimizing the risk that product does not meet quality specifications, which would otherwise require manufacturers to dump the product and take a financial loss. Undetected leaks can lead to brand damaging product recalls.
“The basics of the water used to clean, rinse, as well as to be used in production is very critical to the function of any manufacturer. TOC water testing analysis is more accurate than using other tools for determining equipment cleanliness prior to sterilization,” said Lee. “By using TOC analysis, plant supervisors can better understand their carbon loading to ensure water quality is continually optimal and free of organic contamination, which in turn helps the facility minimize the risk of financial loss and product recall.”
TOC analyzers measure the amount of organic, inorganic, or total carbon in water samples. This works by oxidizing the organic compound into a form that can be quantified. Oxidizing organic carbon produces CO2, which can then be measured and converted into a TOC value or measurement.
According to the company, at NJ Labs, TOC analyses are done using the state-of-the-art Fusion Analyzer from Teledyne Tekmar. This modern laboratory instrument is designed to determine the carbon content in water and other materials. TOC water testing analysis is essential in the pharmaceutical industry for inspection of ultrapure water and evaluation of cleaning effectiveness. TOC analysis has also found wide acceptance in the biotechnology industry to assist in cleaning validation procedures, especially for Clean-In-Place (CIP) procedures. NJ Labs follows strict USP built in set parameters with USP specs that cannot be altered.
For more information, visit https://njlabs.com/importance-of-toc-testing.
