The Environmental Monitoring test involves the incubation and counting of microbial environmental monitors, such as surface samplers, passive air samplers, and active air samplers. Nelson Labs can perform microbial identification work immediately on any growth observed. Environmental control is a requirement of all Good Manufacturing Practices. For setting up an environmental monitoring plan for cleanrooms or other aseptic environments, refer to USP <1116>. In some locations on-site environmental monitoring is available.
For information on water system environmental monitoring, please see Water System Validations.
Applicable Standards
- PDA TR13
- USP 1116
Study Outline
For Environmental Analysis, it is the responsibility of the sponsor to sample its facility according to its procedures. Once the samples arrive at our lab, they are incubated and enumerated. If the samples require any manipulation before incubation, please contact the lab prior to sending.
The total count may be expressed in several different ways depending on the type of sample and sponsor preference. Examples include: colony-forming units (CFU)/plate, CFU/filter, CFU/m3, or CFU/cm2. At the sponsor’s request, samples may be retained for identification or gram stains. Unless otherwise specified, tested samples will be discarded seven days after the study has mailed.
Testing Locations
- Salt Lake City, UT, USA
- Itasca, IL, USA
- Fairfield, NJ, USA
- Ontario, CA, USA
- Mexico City, Mexico
- Espergaerde, Denmark
- Somercotes, England
To learn more about these locations and their certifications, click here.
Contact Us
If you have additional questions about Environmental Air Monitoring test services, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.
