Extractables & Leachables
Bureau Veritas has expertise in designing studies and developing methods to measure extractables in short-term stress tests and leachables in long-term stability studies. Studies rely on a diverse suite of analytical instrumentation including: ICP-MS, IC, HPLC, LC/MS and GC/MS.
The FDA Guidance for Industry Container Closure Systems for Packaging Human Drugs and Biologics, defines many of the requirements for determining the suitability of a container closure system including the need to demonstrate the absence of extractables/leachables or to show that their levels are below the recognized safety guidelines.
Bureau Veritas has developed procedures for characterizing and quantifying the presence of leachable additives, such as calcium or zinc stearate and phthalates from plastic products in a variety of matrices, including:
- Plasticizers (phthalates)
- Mold release agents (stearates)
- Trace metals
- Inks and dyes