Environmental Monitoring involves the incubation and counting of microbial environmental monitors, such as surface samplers, passive air samplers, and active air samplers. Environmental control is a requirement of all Good Manufacturing Practices. Nelson Labs can perform microbial identification work immediately on any growth observed. For setting up an environmental monitoring plan for cleanrooms or other aseptic environments, refer to USP <1116>.
For Environmental Analysis, it is the responsibility of the sponsor to sample their facility according to their 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.
Results: 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.
