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30.08.2021 - Microbiology

ContaminatedHandSanitizer-FDAWarningLetter

Recently, a Warning Letter for a hand sanitizer was issued by the FDA in the USA. The background was that the product was significantly above the specification for the Total Aerobic Microbial Count (TAMC) as well as the Total Yeast and Mold Count (TYMC).

In other products (medicines) from the same manufacturer, the microorganism Burkholderia cepacia was detected. This germ can pose a serious health threat when it comes into contact with injured skin areas.

Have your pharmaceutical products regularly tested for microbiological status. The BAV Institute, as a GMP-certified and FDA-inspected testing laboratory, is at your side with advice and assistance.

We test according to the specifications of the European Pharmacopoeia (Ph.Eur.) as well as according to the methods of the US Pharmacopoeia (USP).