We are a company just starting to work on risk assessment for extractables and leachables after moving from stainless steel, what do you see are the biggest challenges? Any advice on avoiding potential pitfalls?


Supplier may serve as a good source of information and to orient you to how other drug manufacturers manage the topic. A web or literature search will lead to articles that can help to familiarize you. As well, there are several conferences every year on the topic. To complement the educational aspect, you should then embark on your own risk assessment on the topic. It is important to keep in mind that there are several different versions of risk including: product risk, process risk, patient risk. As well, it is essential to understand your organization’s general stance on managing risk. At the extremes, some companies will be very comfortable with technical arguments as to why something is not an issue, whereas others will take the opposite view, leaving nothing to first-principles arguments. Lastly, it is important to include representation from several different functions during the risk assessment/management exercise. When it comes to understanding the extractables / leachables risk associated with single-use technology, some key questions that are top of mind of many users include: the materials of construction of the assembly, the methodology used in the supplier’s extractables studies, and the security of supply and change notification process related to the materials of the assembly. Gathering this information is important for avoiding potential pitfalls related to unexpected outcomes with extractables and leachables.

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