Generation of the Extractables Profile for an Elastomeric Material and Investigation of the Accumulation Behavior of Targeted Leachables Including Bis(2,2,6,6-tetramethyl-4-piperidyl) Sebacate (Tinuvin 770) and a Related Substance

James Story; Martha Gill; Norman Liu; Yousheng Hua; Dennis Jenke

Abstract

The organic extractables profile of a synthetic polyisoprene material being considered for use as a closure on a bag-type packaging system has been delineated. The predominant organic extractables associated with the test material were bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate (Tinuvin 770), several Tinuvin-related substances, fatty acids, and antioxidant-related compounds. Based on their potential product safety impact, Tinuvin and one of its related substances were chosen as target leachables. In order to establish the accumulation behavior of these target leachables under conditions that simulate the desired application, monobags (100-mL fill volume) and multichambered bags (1000-mL fill volume) were constructed with injection sites made from the test material, filled with water, and subjected to accelerated aging including multiple sterilization cycles and long-term storage at 40 °C. Even under the worse-case contact conditions, the accumulation levels of the target leachables were much less than their total available pool in the injection sites.

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