Contamination Control

Microbial contaminations in sterile operations

In quality control operations of the pharmaceutical, medical device, health, and food industries, strain tracking is often demanded in order to identify sources of microbes found to be contaminating the product or the production environment. Criteria essential for efficiently tracking the origins of strains are speed, accuracy, precision, and cost effectiveness.

Molzym is a contract laboratory providing culture-independent microbial identification services. Based on validated PCR assays, Molzym provides an ultra-sensitive microbial detection system. Bacterial and fungal DNA detected in samples is subsequently sequenced and identified using Molzym’s SepsiTest™ BLAST search tool (www.sepsitest-blast.net).
Molzym identifies more than 7,300 microbial species on the grounds of a quality-controlled database of 16S and 18S rRNA gene sequences of bacteria, yeasts and other pathogenic fungi.
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Case Study

A biopharmaceutical company repeatedly had issues with non-mycoplasma contaminations. The contamination occurred in sporadic episodes. Molzym investigated all raw products, plastics and consumables using UMD. Several lots were investigated for each component and Molzym found sporadic bacterial contaminations in plastics. In addition, a low level of fungal cells typical for air condition systems was found. Based on these findings Molzym was able to identify the sources of contamination. Molzym's Clinical Services developed a customized protocol based on UMD and validated SOPs (standard operating procedures) for customers’ in-house QC of all relevant components.

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