By Erin Bakes, Chemistry Study Director
Total Organic Carbon (TOC) is a very sensitive test that helps medical device manufacturers in two main areas: (1) ensuring USP and EP standards for water quality are met, and (2) validating the cleanliness of single-use and reusable medical devices.
TOC testing should be conducted to ensure system or packaged purified water coming into the facility contain safe levels of organic compounds for use in pharmaceutical and medical device manufacturing. Using water with a high grade of chemical and biological purity is a vital step in many pharmaceutical and medical device manufacturing processes.
Medical devices are exposed to various forms of contamination as part of the manufacturing process. Whether those contaminants come from machining fluids or cleaning agents, any organic and water-soluble compound can be monitored using TOC analysis. TOC is also a common marker used to examine the biological and chemical residue that remains after the use and cleaning of medical devices in healthcare facilities.
For both single-use and reusable cleaning validations, a device can be immersed and extracted in USP purified water. The extract is then analyzed to measure the amount of carbon residue extracted from the surface of the device. Alternatively, low-TOC swabs can be used to check the levels of carbon contaminants found on large clean-in-place equipment.
TOC is a great test for routine monitoring. It allows you to watch for spikes in contaminants among your medical devices. Nelson Laboratories recommends checking your process on a batch release basis, which lets you proactively address any issues that appear with the production of your medical device.