Agawam, MA, USA

104 Gold St
Agawam, MA 01001, USA

Tel: +1 413-786-1680
Fax: +1 919-206-7279

En savoir plus sur cet établissement

Overview

Our team in Agawam offers a full suite of microbiological, analytical, and environmental monitoring services to support pharmaceutical and medical device product development. The facility is FDA and DEA registered, has ANAB accreditation and a Massachusetts Radiation Materials License. Our satellite office in Marlborough, Massachusetts is located just 32 miles from the heart of the Cambridge-Boston area.

Facility Details

In Agawam, we have three laboratory service groups:

Microbiological

  • *Sterility (direct immersion, open membrane filtration, closed membrane filtration)
  • *Endotoxin (gel clot, chromogenic, turbidimetric methods)
  • *Bioburden
  • Microbial examination of non-sterile products (USP <60, <61>, <62>)
  • Microbial identification (phenotypic, genotypic, and Gram staining)
  • Antimicrobial effectiveness
  • Disinfectant qualifications
  • Growth promotion testing
  • Filter validation (bacterial filter retention and bubble point testing)
  • Biological indicators
  • Water testing (bioburden, coliform)
  • Mycoplasma
  • Media fills
  • CCIT
  • Customized studies

Analytical

  • Compendial testing per the USP, EP, BP, JP, JPE, ACS
  • Compendial method verifications
  • Analytical method validation and transfer studies
  • Cleaning validation (specific and non-specific methods)
  • ICH stability storage and testing
  • CCIT
  • *Residual ethylene oxide (EO) testing
  • ASTM package testing

Environmental Monitoring & Cleanroom Services

We offer environmental monitoring services throughout New England and in the greater Albany, NY area, including:

  • Routine environmental monitoring, qualification, and certification
  • 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, heterotrophic plate count)
  • Temperature and humidity monitoring
  • Differential pressure monitoring
  • Incubation
  • Enumeration and reporting
  • Courier services for our clients within a 150-mile radius of the Agawam facility. Download our courier request form here.

For our Agawam site’s registration certifications, see our forms and certifications.

*ANAB accredited