Whitepaper: Extractable and leachables studies – designed and performed to meet all intended needs

Following FDA legislation in 1999, scrutinising packaging standards for extractables and leachables has become the norm. In this whitepaper, Eurofins examines the ways in which the evaluation of final packaging components is now carried out including the role of liquid and gas chromatography-mass spectrometry in the process.

Since the FDA released their Container Closure Systems for Packaging Human Drugs and Biologics guidance in 1999, evaluation of final packaging components for extractables and leachables has become the expectation within the industry. Additionally, the increase in the use of single-use systems in manufacturing has drawn scrutiny as another potential source of extractables and leachables. These single-use systems include bioprocess bags, filters, tubing, fittings, connectors, bioreactors, etc. Many of these single-use systems are constructed from polymeric materials, increasing the concern of the introduction of leachable compounds to product.