Microbial Identification

Microbial identification is the process of identifying and characterizing microorganisms such as bacteria, viruses, and fungi. This can be done by analyzing the organism's genetic makeup, proteins, or other characteristics. In the pharmaceutical industry, microbial identification is particularly important to ensure the safety and efficacy of pharmaceutical products. By identifying microorganisms, scientists can better understand their behavior, potential risks, and take appropriate treatment options. At Alfa Chemistry, we offer microbial identification services tailored to the needs of the pharmaceutical industry. Our team of experienced scientists uses cutting-edge technology and methodologies to accurately identify a wide range of microorganisms.

How can our microbial identification service help you?

• Compliance With Regulations: Various regulations and standards, such as ISO 11137-2, emphasize the importance of not only quantifying total microorganisms in products but also characterizing and identifying them.
• Cleanroom Control: Microbial identification assists in monitoring and controlling cleanroom production areas by tracking trends in background flora, both in terms of quantity and type. This enables early detection of potential contamination issues and facilitates prompt corrective actions.
• Traceability: Identifying microorganisms provides valuable information for establishing traceability in raw materials, production processes, and surfaces within pharmaceutical facilities. This tracking mechanism is essential for quality control and risk management.
• Product Quality Assurance: Microbial identification helps in identifying and characterizing microorganisms present in pharmaceutical products to ensure they meet the required purity and quality standards.
• Out-of-specification Investigations: Microbial identification provides additional insight into identifying potential sources of contamination and deviations from specified standards for arise during dose audits, sterility testing, bioburden testing, bacterial endotoxin testing (LAL), and biological indicator testing.

Our microbial identification service offers four levels of identification:

Strategies of microbial identification at Alfa Chemistry include:

Genotypic Identification

Genotypic identification is a method of microbial identification that focuses on analyzing the genetic makeup of microorganisms. One common genotypic identification technique used in our regular service is Unilocus Comparative Sequencing (ULSA). The details are shown below.

• For bacteria identification, this method involves sequencing the 16S rRNA gene, which consists of more than 1,350 base pairs. By using PCR to amplify the gene, followed by double-strand sequencing and comparison to our validated proprietary database. This technique can achieve genus and species-level identification with high accuracy and is more precise than partial sequencing, providing rapid, reliable, and efficient results.
• For fungi identification, we utilize either the 18S, 25S rRNA gene or ITS1/ITS2 partial sequencing. This technique can achieve genus and species-level identification of fungi rapidly, reliably, and efficiently.

Proteotypic Identification

Proteotypic identification is another method of microbial identification available in our regular service. This technique involves MALDI-TOF mass spectrometry organism identification, which is used for identifying both bacteria and yeast. By creating a unique proteomic fingerprint of an organism through MALDI-TOF mass spectrometry, we can match characteristic patterns within the instrument library. Our instrument library consists of over 11,000 entries spanning more than 4,000 species of bacteria and yeasts, enabling gene and species-level identifications. This method offers rapid identification testing (within minutes) and is more cost-effective compared to other techniques.

Alfa Chemistry's advantages: