Extractables & leachables evaluation of single-use systems for biopharmaceuticals, moving toward new industrial standards – Part 2*


Extractables & Leachables, Impurity Profiling SGS INSTITUT FRESENIUS, GmbH, Wiesbaden, Germany


The method by which single-use components are qualified and validated has been a source of controversial discussion between the end user, supplier groups and regulatory experts. Recently, there has been increased collaboration between the industry groups to work out strategies to help to determine whether a single-use component has been sufficiently and appropriately tested for extractables/leachables. Collaboration between these industry bodies allows to monitor where the industry is going and develop best practice approaches, which may then be incorporated into regulatory guidance.


Polymeric pharmaceutical processing materials (such as single-use systems) must be evaluated to determine whether they impact on the final drug product as regards safety and efficacy. For SUS, this usually leads to evaluation and demonstration of compatibility with the drug product under process conditions. Many of these evaluations can be made by the materials suppliers as described in the first part of this article.

The process begins with the selection of manufacturing components, and with the proactive design of process qualifications and validation requirements for materials. Various polymeric materials used in SUS construction tend to leach out chemicals over time, thus we need a detailed extractables and leachables study that is designed from an analytical point of view. Collaboration between supplier and end user industry bodies has led to several benefits, as it allows the industry to effectively self-control by by providing best practice approaches, which may then be incorporated into regulatory guidance. While there is some movement on standardization of extraction conditions, a con ...