We provide environmental monitoring services to evaluate your cleaning and disinfection programs, assessing the microbial cleanliness of your manufacturing environment per USP <1116> Microbiological Evaluation of Clean Rooms and Other Controlled Environments. This information will enable you to control microorganism levels in the manufacturing environment and minimize the bioburden on the item that is manufactured.

With our help, you can confidently implement environmental monitoring programs in cleanrooms, manufacturing plants, packaging facilities, testing laboratories and other areas where microbial and particulate control are critical to the quality of operations and production, such as medical device manufacturing and packaging, sterile and aseptic production and fill environments, and sterile and aseptic product primary and secondary packaging areas.

We take air and surface samples during production to obtain a microbiological profile of the manufacturing environment and record additional observations of work practices during the survey. Our experts evaluate the data to determine any actions you can take to reduce or stabilize the bioburden of the medical product or production area.

Programs include viable and nonviable air monitoring, cleaning effectiveness, equipment monitoring, surface monitoring, disinfectant efficacy, gowning and personnel monitoring, compressed air testing, compressed gas testing and water system validation monitoring.

New facilities, new programs, construction areas, adjacent areas, post-construction areas and change control typically warrant a risk assessment and program design that may include evaluation of:

  • Baseline bioburden and particulates (often including seasonal trending)
  • Identification of organisms across the baseline sample
  • Process, procedure and practice

Once we conduct a comprehensive evaluation, we recommend a program be implemented with a defined frequency and specifications established either by regulatory requirements or trending data.

Contact our analytical testing team by clicking below