Extractables & leachables evaluation of single-use systems for biopharmaceuticals, moving toward new industrial standards – PART 1


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


Single-use processing equipment is increasingly becoming a part of biopharmaceutical development and manufacturing. This has made it necessary that we acquire a clear understanding of risk management and testing requirements and improve such processes. Traditionally, pharmaceutical manufacturing facilities were equipped with stainless steel equipment operated with a relatively small proportion of purchased consumables. In modern biopharmaceutical processes, batches of a finished drug product can be manufactured with systems where most product contact surface are disposable components made of plastics and that are required to be sourced from the supply chain. With the shift from stainless steel equipment to single-use systems, the risk that leachables may be unintentionally introduced in the process stream has increased and risk mitigation strategies must be developed to avoid contamination of the finished drug product. In these terms, the supply industry will increasingly become an integral part of end users operations.


Single-use systems are now widely used in pharmaceutical production. They are mostly made of polymeric materials, which has led these single-use systems to be rapidly preferred over metal, ceramics and glass components that were previously predominant in the manufacturing process. This transition has led to a more flexible method of manufacturing biopharmaceuticals, and brought about an increase in continuous manufacturing of active pharmaceutical ingredients (APIs), which are produced in compact, closed units, with a higher degree of automation and fewer manual interventions. This allows to integrate the manufacturing phases into a continuous process, as opposed to carrying them out sequentially in a classic batch process. 

The purchasing strategy of single-use systems for the end user must ensure that suppliers deliver equipment that has the specified functionality, and that they deliver it in a timely manner. Using plastic components in pharmaceutical production requires to carry out risk assessment, followed by a safety assessment to ensure that all the polymeric materials that come into ...