Microbiology Testing

Boston Analytical offers an extensive line of microbiological testing services for pharmaceuticals, biopharmaceuticals, and medical devices. Our experienced team of Microbiologists, along with your dedicated Project Manager, can assist you with both routine testing requirements, or they will work with you to develop and refine existing methods to meet any requirements you may have. Our FDA/DEA Registered, cGMP compliant, and ISO/IEC-17025:2005 certified laboratory is well equipped with the latest technology and instrumentation, ensuring timely and accurate testing results.

Our Microbiological Testing Services include:

Microbiology testing
  • Sterility – Class 100 Glove Box Isolator Technology with Vaporized Hydrogen Peroxide (VHP) Sterilization System
    • Membrane Filtration or Direct Inoculation Testing under USP/EP guidelines
  • Species level identification via DNA
    • Microseq 3130xl from Applied Biosystems
  • Endotoxin Testing under USP/EP guidelines
    • Gel Clot
    • Kinectic Chromogenic
    • Turbidimetric
  • Water Testing
    • USP <1231>
    • Total Organic Carbon (TOC) - USP <643> using Sievers 900
    • Conductivity - USP <645>
  • Environmental Monitoring
    • On-site Environmental Monitoring in compliance with USP <1116>
    • Disinfectant Efficacy Studies – USP <1072>
    • Viable and Non-Viable Particulate Air Monitoring
    • Viable Surface Monitoring
    • Bacterial and Fungal Identification and Enumeration
    • Supplies provided to those that perform in-house environmental monitoring
  • Water Activity Testing
    • Volatile and Non-Volatile solids and liquids – USP <1112>
  • Microbial Enumeration Testing – USP <61>
  • Absence of Specified Microorganisms – USP <62>
  • Antimicrobial Effectiveness Testing – USP <51> Preservation Efficacy Testing (PET)
  • Biological Indicator Testing – USP <55> and USP <1035>
    • Spore Suspension
    • Strips
    • Ampoules
    • Metal Disc
  • Particulate Analysis – USP <788> and USP <789>

Along with offering a wide variety of microbiological testing services, we also utilize LabWare Inc.'s LIMS/ELN software systems to ensure your experience with Boston Analytical is the best it can be. With the ability to follow your sample electronically from the moment it is logged in, we capture all data and results directly through the LIMS/ELN system, ensuring accuracy and consistency.

At Boston Analytical, we are committed to providing you with quality service, timely turnaround, unsurpassed responsiveness and, and open communication. Whether you need consultative services or routine testing, Boston Analytical is there for all of your microbiological testing needs.

For more information on our Microbiological services, please contact us today.