Water System Validations & Monitoring
Water System Validations & Monitoring
Water testing is used to assess the chemical purity and microbiological composition of water samples. All Good Manufacturing Practices (GMPs) call for microbial management due to the importance of water in the environment. This can include source water, process water, refined water, deionized water, and highly purified water. It is recommended to regularly check the water system to make sure the manufacturer’s acceptance standards and bioburden monitoring procedures are followed.
Writing IQ/OQ/PQ protocols, sampling strategies, determining test frequency, and failure investigations are all services our Technical Consulting team can provide. When conducting analyses, the Standard Procedures for Examination of Water and Wastewater is typically used as a guide. This calls for the use of membrane filtration and R2A agar. Plating can be done on soybean casein digest agar or selective agar for fungal growth, depending on the kind of water.
The sponsor must determine the condition for incubation duration, temperature, and the quantity of samples that will be filtered before testing can begin. The type of water sample affects these variables. Additionally, the water is scanned using equipment to detect conductivity and TOC for the analytical component of the testing. TOC is a very sensitive parts per billion (ppb) test method for screening organic material in the water that is often indicative of a high organism count.
Water testing is an important part of GMP and regular monitoring is necessary to ensure the water system is functioning correctly and safely. Our Technical Consulting team can provide support with protocols, sampling strategies, and more.
