Overview

From our site in Agawam, MA, we offer a full suite of microbiological, analytical and environmental monitoring services to support pharmaceutical and medical device product development:

  • Microbiological: Sterility, Direct Immersion, Open Membrane Filtration, Closed Membrane Filtration, Endotoxin (Gel Clot, Chromogenic, Turbidimetric methods), Bioburden, Microbial limits, Microbial Identification (Phenotypic and Genotypic), Antimicrobial Effectiveness, Disinfectant Qualifications, Growth Promotion, Filter Validation (bacterial filter retention and bubble point testing), Biological Indicators
  • Analytical: Compendial monograph testing per the USP, EP, BP, JP, JPE, ACS; Compendial method verification and validation studies, Analytical method transfer studies, Cleaning validation (specific and non-specific methods), ICH stability storage and testing, Residual solvents per USP 467, CCIT, Water testing, Liquid particulate counting – USP <787> <788> & <789>, Residual ethylene oxide (EO) testing
  • Environmental Monitoring (cleanroom services): Routine Environmental Monitoring, Total Particulate, Active Viable Air Monitoring, Passive Viable Air Monitoring, Viable Surface Monitoring, Personnel Monitoring, Compressed Air/Gas Monitoring (Moisture, Oil, N2, Mixed Gases), Water System Monitoring (TOC, Conductivity, Nitrates, Heavy Metals, Heterotrophic Plate Count), Temperature and Humidity Monitoring, Differential Pressure Monitoring, Incubation, Enumeration & Reporting

Home to a team of almost 80, the site is comprised of 36,000 square feet with 15,000 square feet of GMP laboratory space and is staffed with 44 scientists.

The facility is FDA and DEA registered, has ANAB accreditation and a Massachusetts Radiation Materials License.

We offer Environmental Monitoring services throughout New England through our satellite office in Marlborough, Massachusetts. This space is 3,000 square feet and is located 32 miles from the heart of the Cambridge-Boston area.

For the convenience of our sponsors, the Agawam site also employs a courier service that will travel throughout New England picking up samples and returning them to the Agawam laboratories for analyses.

Facility details

  • Fully cGMP Complaint
  • FDA Registered
  • ISO 17025 Accreditation
  • Provide pharmaceutical and medical device product development services.
  • Three Laboratory Service Groups:
    • Microbiological
    • Analytical
    • Environmental Monitoring (Cleanroom Services)
  • Support Functions:
    • Courier Services
    • Laboratory Support Services
    • Metrology
    • Validations
    • Account Management
    • Facilities
    • IT, Finance