WuXi AppTec’s robust approach to microbial identification (ID) testing surpasses the industry standard offered by other laboratories.
Our clients come to us when a microbial excursion has occurred. Understanding what the microbial contaminants are, and where they have been introduced into the manufacturing process, is critical in determining the root cause of the microbial excursion, as well as effective corrective actions to prevent re-occurrence. In the manufacturing process, microbial contaminants may be isolated from many different locations and sources, including employees, air, water, surfaces, raw materials and even the final product. The first step in our identification process is to obtain a pure culture of any microbial isolates found. Once isolation has been obtained, we begin our all-inclusive approach to microbial identification. The following are included in our microbial ID testing:
- Subculturing to the point where a single, pure, isolated colony is obtained, as well as using two ID systems: VITEK® MS and Applied Biosystems® DNA sequencer.
We do not charge for subculturing, Gram staining or additional ID methods.
- For one price per isolate, we subculture for isolation and Gram stain, and we attempt to identify the microbial isolate up to three times using the VITEK MS, DNA sequencer or macroscopic ID for mold isolates.
We know manufacturers spend significant time and resources subculturing in-house to ensure a culture of less than 72 hours is delivered (a requirement for other labs). WuXi AppTec clients, however, do not have to send a culture that is less than 72 hours old. We perform this task and save clients resources, time and costs. In our own laboratories, we control testing processes for contamination – including microorganisms – to be compliant with the manufacturing quality system, processes, procedures and standards set for the industry. Let us show you how our experienced experts can provide a one-stop-shop approach for microbial identification.