MICROBIOLOGY TESTING

Accuracy from experience, flexibility for your requirements

MICROBIOLOGY TESTING

Accuracy from experience, flexibility for your requirements

Microbiome

Boston Analytical has a proven track record on a variety of microbiome programs, including spore fraction and defined drug product manufacturing processes. We can provide you with the assistance needed to help your gut microbial imbalance drug advance on its development path.

Microbial Identification

Boston Analytical can accurately identify a microbial contaminant the same day the isolate is submitted, using either a 3130XL Genetic Analyzer or the Bruker Biotyper® MALDI-TOF system. With this information quickly in hand you can make adjustments to your manufacturing process to avoid contamination.

Pharmaceutical Testing

Boston Analytical provides a complete spectrum of microbiological testing for pharmaceuticals, including bacterial endotoxin testing, biological indicator testing, VHP sterility testing, and in vitro microbial kill rate studies. These tests can help you verify there are no endotoxins present in your manufacturing process stream.

Medical Devices Testing

At Boston Analytical, we help you ensure medical devices are sterile, offering sterility testing, bioburden validation and testing, and bacterial endotoxin testing. We can assist you by providing information that will indicate if there are any sterility issues with your medical devices.

Cleanroom

Boston Analytical provides on-site microbial air and surface environmental monitoring services for cleanrooms, USP <797> compliant laboratories, ISO cleanrooms, and other controlled environments. If you perform environmental monitoring in-house we can help you ensure your site is properly maintained.

Utilities Testing

Boston Analytical offers a complete line of compressed air and purified water testing services, with a rapid turnaround time. Our experienced staff can help you determine the specific tests you need and assist with sample collection.

Contamination Response Investigation

Boston Analytical has worked with clients to respond to biofilm formations, disinfectant neutralization, efficacy validation, cleanroom validation, and water system specification failures. Boston Analytical provides expert root-cause analysis and on-site consultation.