Comprehensive Microbial Identification Solutions for Regulated Industries
When unexpected microbial contamination occurs, speed and accuracy are critical. Nelson Labs offers microbial identification solutions that go beyond basic lab testing — delivering expert-driven strategies that help pharmaceutical, medical device, and tissue manufacturers meet the highest standards of quality and compliance.
Our solutions combine cutting-edge identification methods such as MALDI-TOF, 16S/28S sequencing, and phenotypic analysis with expert interpretation tailored to your product type and regulatory pathway. Whether you’re investigating a contamination source, qualifying a cleanroom, or supporting a regulatory submission, our microbial ID services are built to solve real-world production and patient safety challenges.
Backed by decades of experience and a consultative approach, we help clients understand not only what organisms are present — but also why they matter and how to respond.
Test systems available are:
- Gram Stain: Assesses colony morphology, cell morphology, and Gram reaction to confirm culture purity and distinguish bacteria from yeast (does not provide species-level identification).
- Genotypic Identification (DNA Sequencing): Provides species-level ID; targets the 16S rRNA gene (bacteria) and the LSU D2 gene (fungi) and then compares sequences against validated databases for precise results.
- MALDI-TOF Identification (Matrix-Assisted Laser Desorption Ionization – Time of Flight): Uses mass spectrometry to analyze ionized proteins from bacterial or fungal samples. The resulting spectra are compared to a database for genus or species-level identification.
- Additional information on the IDT200 identification method can be found here. Please note that MALDI-TOF identification is only available at the Salt Lake City facility.
Diverse Sample Acceptance: We’re equipped to handle a variety of sample types, including:
- Isolated cultures (on plates, slopes, or in broth)
- Mixed cultures
- Environmental monitoring
- Water samples
- Contaminated product samples
Applicable Standards
- USP <71>
- ISO 11737
- USP <1113>
- USP <61>
- USP <62>
