Analytical Solutions for Extractables, Leachables, and Migration Testing

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Product packaging – whether plastic, rubber, cardboard, metal, or glass – acts as a barrier against all sorts of contamination. But these materials can themselves provide a source of contamination. It is not a
question of whether packaging components will leach into a product – it’s a question of how much. Aside from the direct migration of chemicals from containers, packaging can also be exposed to problematic materials during production, storage, and transport. These chemicals can later leach into the product stored in the containers.

The need for extractables and leachables testing is likely to grow. In pharmaceutical manufacturing, single-use systems (SUS) with plastic components are seeing increased use – and nearly three-quarters of biopharmaceutical manufacturers surveyed recently expressed concern about extractables and leachables from SUS. Meanwhile, the food industry continues to experience an increased focus on everything from food-safe inks to adhesives. New regulations for ensuring the safety of packaging material and products in industries such as food, cosmetics, and pharmaceuticals are requiring analytical testing to be more rigorous – which can add time and cost to the process.

In this demanding environment, Waters provides analytical solutions and techniques that effectively address the chemical diversity found in samples so that you can:

■ Maximize separation for complex samples reliably and routinely.
■ Obtain the highest level of structural information that reveals even trace amount of compounds.
■ Visualize, process, and report data more effectively to support compliance documentation.
■ Make critical decisions in less time with greater confidence using tools and techniques to improve workflow and increase testing throughput.

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