Possible Outcomes of a Leachables Study

August 13, 2018

At the end of the stability study, results from the leachables analyses will be reported.  There are two basic outcomes to a leachables study:

  1. Good news: At the end of the stability study, all leachables were below the AET.
  • No action needed
  • Container closure system has no impact on shelf life

  1. Bad News: One (or more) leachable exceeded the AET at or before the intended shelf life.
  • Assess toxicity of the leachable to determine if SCT was appropriate. If SCT increases after assessment, AET can increase.
  • If after confirmation and toxicity assessment the leachable is still above the AET, shelf life must decrease to time when leachable was below AET.
  • In worst case scenario, a new container closure system may be needed.