Purified water is used throughout the manufacturing process of a pharmaceutical product, from API production through to packaging of the final product. It’s extremely important to ensure that chemical impurities and microorganisms are not introduced to the pharmaceutical product via water sources, compromising the quality of the final product, therefore quality testing is a strict requirement to ensure patient safety.
We perform bacterial endotoxin testing and test to USP <1231>, <643> & <645>. Key stages of the manufacturing process that can be tested for include water used as; an excipient, a cleaning agent for rinsing vessels and equipment, a reconstitution of products or as part of the final product production. We analyse samples from potable water, in-house water systems, water for injection and many other sources.
Whether it’s analysing water quality to pharmacopoeial monographs (Ph. Eur., USP, BP, JP), HTM directives, Microbiology of Drinking Water or Total Organic Carbon (TOC) – at Lucideon we can help.