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