Microbiology Testing Services

Boston Analytical offers a complete line of cGMP/GLP testing services to the Pharmaceutical, Medical Device and Biotechnology industries.

Testing is performed according to official USP/NF and other compendial procedures as well as AAMI, ISO and client SOP's.

We employ a validated class 100 glove box (isolator) with VHP sterilization for state of the art sterility testing and numerous class 100 Biological Safety Cabinets.

At Boston Analytical we are committed to providing quality service, rapid turnaround, effective communications and competitive pricing to guarantee your satisfaction.

• Antimicrobial Effectiveness Testing - USP <51>
  Product challenge with five indicator organisms
  
  
• Microbial Limits Testing - USP <61>
  Screening Test and Preparatory Validation Method
  
  
• Sterility Testing - USP <71>
  Class 100 Glove Box with VHP Sterilization
  Membrane Filtration or Direct Immersion
  Sterile Product Packaging - Integrity Evaluation - <1207>
  Validation of Isolator Systems - USP <1208>
  New Product test for Bacteriostasis / Fungistasis
  
  
• Bacterial Endotoxin Testing - USP <85>
  LAL - Gel Clot Method
  Inhibition / Enhancement Testing
  
  
• Water for Pharmaceutical Purposes - USP <1231>
  Pathogen Screens / Total Organic Carbon
  
  
• Particle Size Testing - USP <788>
  Parenterals / Ophthalmics
  
  
• Environmental Monitoring - USP <1116>
  Microbiological Evaluation of Clean Rooms and other controlled environments
  Non-Viable and Viable air monitoring.
  Viable Surface Monitoring via Rodac Plates and Swabs
  
  
• Microbial Identification via Comparative
  DNA Sequencing Technology
  Applied BioSystems 3130-XL with MicroSeq ®
  Highly Accurate and Rapid Bacteria and Fungi Identifications