08.02.22
A flood of warning letters from FDA on water system suitability could create major issues for the production of food, beverages, cosmetics, and over-the-counter or pharmaceutical products if companies are not conducting total organic carbon (TOC) water testing analysis regularly, according to third-party testing company NJ Labs.
FDA has reprimanded a number of firms for, among other things, missing validation on water testing, such as one that was issued to a manufacturer called Agropharma in March. 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, according to NJ Labs.
Depending on the product being manufactured, a manufacturer is subject to distinct water purity standards, and failure to correct a water system can result in legal actions including seizures and injunctions, as well as withheld contracts, export certificates, or new application approvals from the agency.
“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.”
According to NJ Labs, 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 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,” Lee said. “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 by oxidizing the organic compound into a form that can be quantified. The oxidization produces CO2, which can be measured and converted into a TOC value or measurement.
NJ Labs conducts TOC analysis with a Fusion Analyzer from Teledyne Tekmar. This instrument can determine the carbon content in water and other materials, and can be used in the pharmaceutical industry to inspect ultrapure water and evaluate cleaning effectiveness. TOC analysis is also widely accepted in the biotechnology industry to assist in cleaning validation procedures, especially for Clean-In-Place procedures.
NJ Labs follows USP built in set parameters with USP specs that cannot be altered.
FDA has reprimanded a number of firms for, among other things, missing validation on water testing, such as one that was issued to a manufacturer called Agropharma in March. 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, according to NJ Labs.
Depending on the product being manufactured, a manufacturer is subject to distinct water purity standards, and failure to correct a water system can result in legal actions including seizures and injunctions, as well as withheld contracts, export certificates, or new application approvals from the agency.
“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.”
According to NJ Labs, 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 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,” Lee said. “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 by oxidizing the organic compound into a form that can be quantified. The oxidization produces CO2, which can be measured and converted into a TOC value or measurement.
NJ Labs conducts TOC analysis with a Fusion Analyzer from Teledyne Tekmar. This instrument can determine the carbon content in water and other materials, and can be used in the pharmaceutical industry to inspect ultrapure water and evaluate cleaning effectiveness. TOC analysis is also widely accepted in the biotechnology industry to assist in cleaning validation procedures, especially for Clean-In-Place procedures.
NJ Labs follows USP built in set parameters with USP specs that cannot be altered.
