Environmental Monitoring

Cleanrooms are designed to minimize contamination, which is critical in the production of high-quality pharmaceutical products and medical devices. Scientists from our Agawam, MA site perform environmental monitoring and cleanroom services throughout the New England region and the greater Albany, NY area in tightly controlled environments that minimize contamination. We work with you to identify your testing needs and build a well-designed, risk-based environmental monitoring program, including services such as total air particulate testing, viable surface and air testing and compressed gas testing.

Our scientists will sample water systems and return those samples to our Agawam facility for Total Organic Carbon (TOC), conductivity, nitrate, bioburden and endotoxin analyses.

As part of our comprehensive environmental monitoring and critical utility testing, support and services, we ensure the quality of your manufacturing environments specific to API, aseptic or oral dose manufacturing, as well as terminally-sterilized medical device and component manufacturing.

Whether you’re looking for routine environmental monitoring, certification, validation or training, we offer a wide variety of services to ensure your needs are met, including the following:

• Routine Environmental Monitoring — Our experts will work with you to define your program, from frequency and duration of testing to specific methods and sampling plans.
• ISO 14644-2:2015 Risk Assessment — We will partner with your team to identify hazards and evaluate the risks associated with maintaining your facility’s control of microbiological contamination.
• Cleanroom Qualification Support — Cambrex’s cGMP-trained analysts provide full technical oversight for cleanroom qualifications and certifications — from start to finish.
• Compressed Gas Monitoring — Our experienced scientists can support your organization’s compliance with cGMP regulations and assist with establishing the testing program and parameters based on your needs.
• Microbial Identification — Using genetic sequencing or MALDI-TOF mass spectral analysis, our state-of-the-art lab can identify specific species of bacteria, fungi and yeasts.
• Media plate analysis — We deliver quality control-tested media for your use, and then conduct incubation and analysis after the plates are returned.
• Courier Services — We provide a courier service available to clients located in the New England area, and portions of New York, within a 150-mile radius of the Agawam facility. Our experts will pick up and deliver your samples to our laboratory for analyses.

Need Courier Services in New England?

If you’re interested in our courier services, please complete the courier request form below and return it to courier‐ma@cambrex.com.

Courier Request Form