Microbial contamination can jeopardise both product performance and patient safety—making rapid identification and resolution critical at every stage of medical device development. From sterility test failures to cleanroom validation, manufacturers are expected to act quickly, accurately, and in line with evolving regulatory frameworks. Doing so efficiently under pressure is often easier said than done.

Eurofins Medical Device Services network of laboratories is equipped to support you with fast, precise, and regulatory-aligned microbial identification (ID) and typing services. From identification of environmental isolates, through to expert analysis of finished product contaminants and out-of-specification investigations, our comprehensive service offering minimises risk, accelerates resolution, and maintains product integrity. You’ll benefit from access to expert scientists, state-of-the-art instrumentation, and robust, validated methodologies that align with international standards..

By leveraging one of the largest microbial reference libraries for bacteria and fungi in the world, our microbiologists can identify predominant organisms recovered during sterilisation dose audits per ISO 11737, as well as detect objectionable organisms in line with AAMI ST 72 and product-specific requirements. With turnaround times as fast as 3–5 business days, and priority processing available, we help reduce costly delays and bring clarity to complex situations through our comprehensive microbial identification support.

Microbial identification

Genotypic Identification

Regular Service

Unilocus Comparative Sequencing (ULSA)

Bacteria: 16S rRNA Gene Long Sequencing
Uses PCR to amplify more than 1,350 base pairs, double strand sequencing and comparison to our validated, proprietary database, Eurofins Microbial Sequencing Index (EMSI), including more than 9,260  valid type strains.

• Genus and species level identification.
• More accurate than partial sequencing.
• Rapid, reliable and efficient.

Fungi: 25S rRNA Gene or ITS1/ITS2 Partial Sequencing
Uses 25S rRNA gene.

• Genus and species level identification.
• Rapid, reliable and efficient.

Expert Service

Multilocus Comparative Sequencing (MLSA)

Solves drawbacks from 16S rRNA (bacteria) or 25S rRNA genes, ITS1 and/or ITS2 (fungi), sequencing by increasing resolution to further discriminate at the species level.

• Application to strain typing (MLST).
• Simultaneous comparative sequencing of multiple genes (housekeeping genes) of taxonomical interest and extended databases of reference sequences: bacteria and moulds.

Proteotypic Identification

MALDI-TOF Mass spectrometry Organism Identification

Bacteria and Yeast identification

Uses MALDI-TOF mass spectrometry to create a unique proteomic fingerprint of an organism. This fingerprint  matches characteristic patterns within the instrument library. The instrument library consists of over 11,000 entries that span more than 4,000 species of bacteria and yeasts.

• Gene and species level identifications
• More cost-effective method
• Rapid identification testing

Molecular Typing

To characterise strains within the same species and to compare strains of the same species with each other.

• Arbitrary Primed PCR (APPCR)
• MicroSatellite Analysis (MSAT)
• MultiLocus Sequence Typing (MLST)
• Pulse Field Gel Electrophoresis (CHEF)
• Reference Methods
• Variable Number of Tandem Repeats (VNTR)

Reference Methods

Eurofins Medical Device Services' methods follow the most current requirements outlined in:

• AAMI ST 72
• ISO 11737