T/CAMDI 077-2022 Active

Scope: This document describes the test method for the residual amount of dicyclopentadiene (DCPD) in medical styrene-based thermoplastic elastomers (TPE-S). This document is applicable to the determination of DCPD residuals in styrene-based thermoplastic elastomers used for infusion and storage. Main technical content: Medical styrene-based thermoplastic elastomers (TPE-S) can be mixed with many materials and have a wide range of applications, such as drug infusion and storage devices, large infusion soft bags, and intravenous nutrition infusion bags. During the synthesis of TPE-S, a hydrogenation catalyst, titanium dichloride dicyclopentadiene, is typically introduced. During the post-processing of the rubber solution, the hydrogenation catalyst decomposes to produce dicyclopentadiene, resulting in residual dicyclopentadiene in TPE-S. The diversity and complexity of the media that devices come into contact with during clinical use may lead to the migration of residual dicyclopentadiene, which could pose a safety risk to humans. It may irritate the eyes, skin, respiratory tract, and digestive system and inhibit the central nervous system. Animal tests have found that it can damage the kidneys of rats. Various analytical methods can be used to determine the residual dicyclopentadiene (DCPD) in infusion and storage devices made from styrene-based thermoplastic elastomers. Typical methods include gas chromatography (GC) and gas chromatography/mass spectrometry (GC/MS). This document uses GC as the basic method and provides the experimental procedure.