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Cleaning Limits: Why Should We Abandon Using the 10 ppm Criterion

Lovsin Barle, Ester, Crevoisier, Michel, Flueckiger, Andreas, Ader, Allan and Walsh, Andy (2016) Cleaning Limits: Why Should We Abandon Using the 10 ppm Criterion. Cleaning Limits: Why We Should Abandon Using the 10 ppm Criterion, 40 (1). pp. 52-56.


The 10 ppm criterion for the acceptable concentration of potential active pharmaceutical ingredient in cleaning validation to minimize cross-contamination into next product has been employed for many years. However, it is arbitrary and does not take into account advances in toxicological risk assessment methodologies which allow for robust and scientifically supportable approaches to establish safe or acceptable levels of a drug from one product to the next. Recent guidelines issued by the International Society of Pharmaceutical Engineers (ISPE) in 2010 and a regulatory authority, the European Medicines Agency (EMA) in 2014 employ health-based risk assessments as the basis for stablishing acceptable limits for residual of active pharmaceutical ingredients into next product and most importantly are protective for patient safety. The following paper describes why the 10 ppm criterion which was established based on analytical limitations and estimates of acceptability is no longer acceptable and why a risk-based approach should be universally adopted.

Item Type: Article
Date Deposited: 27 Apr 2016 23:45
Last Modified: 27 Apr 2016 23:45


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