A quest to find the cause of unknown peaks in cleaning verification chromatography following the manufacture of pharmaceutical preparations

摘要

Cleaning equipment following the manufacture of pharmaceutical products is of paramount importance to ensure that the following batch of product manufactured is not contaminated with therapeutic levels of the prior manufactured product. The patient must only receive the therapeutic effect expected from the drug they take. During a number of cleaning verification studies, it was discovered that unknown peaks were present in the chromatography, the source of which was unclear. A study was performed to examine a theory that the gloves used by the operator during the cleaning procedure, in combination with the solvent based cleaning products were responsible for the unknown peaks that were evident in the chromatography. NASA had performed a similar study for the critical parts of the space shuttle in the space shuttle program. The following poster examines the conclusions that were made from the data that was attained for the study. The data will answer the question: ‘Are the gloves themselves responsible by way of leachables for the unknown peaks in the cleaning verification chromatography.‘