IN PARTNERSHIP
The journey of extractables and leachables
Aspen Research Laboratories is a CRO known for its superior understanding of materials science, engineering and analytical testing. Its scientists collaborate with pharma, medical device manufacturers, single-use suppliers, and many other industries to solve challenges and expedite product development.
E
xtractables and leachables testing is done primarily to help ensure that a medical device or pharmaceutical packaging is safe
for its intended use. An extractable is defined as a substance – organic or inorganic chemical entity – that is released from a medical device or material of construction when the medical device or material is extracted using laboratory extraction conditions and vehicles (solvents). A leachable is defined as a substance that is released from a medical device or material during its clinical use (ISO10993-18:2020) or as a foreign organic or inorganic chemical entity that is present in a packaged drug product, because it has leached into the packaged drug product from a packaging/delivery system, packaging component or packaging material of construction under normal conditions of storage and use, or during accelerated drug product stability studies (USP 1663 and 1664).
50 | H1 Virtual Events: Review and Summary Handbook
In the extractables testing field, there are no hard-and-fast rules as to which extracting solvents to use or what the times and temperatures of the extractions must be. There are, however, guidance documents and ISO standards that help direct appropriate testing. Given that the results of the testing are used in regulatory submissions for approval of medical devices and drug products, it is imperative that studies are designed to yield results that can be used to determine if the device or drug product is safe for the intended use.
Designing the extractables study As a contract analytical chemistry laboratory, Aspen Research Laboratories’ clients come to it to not only perform testing, but also to help advise on designing the study, along with performing the analyses involved in the study. This article analyses the journey of
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58
