Controlled Environments

LexaMed is an industry leader for designing, testing, validating and monitoring your controlled environment.  We can help you fulfill  International Organization for Standardization (ISO), European Union (EU), and U.S. Food and Drug Administration (FDA) regimens. LexaMed provides a full range of best-in-class Environmental Monitoring Services which include experienced consultants to help with program development, trained microbiologists to conduct environmental monitoring sampling, use of calibrated sampling equipment and complete testing services.  

Our all-inclusive environmental monitoring program includes development of an environmental monitoring master plan for your facility based on guidance provided in USP Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments or ISO 14698 Cleanrooms and associated controlled environments – Biocontamination control.

The plan will include outlining sampling site selection and rationale, alert and action limit setting, trending review requirements, investigation of over limits and how to qualify the program’s effectiveness. 

For those clients who already have an environmental monitoring program in place we offer a plate supply and analysis-only program in which we provide quality control-tested media plates for your sampling use which can be returned for incubation and analysis by our trained staff.

Our full range of environmental monitoring services include the following:

• Industry recognized Consultants experienced in Controlled Environment Design and Monitoring
• Performance of Active Viable and Non-viable Air and Passive Air Monitoring by trained Microbiologists
• Performance of Viable Surface Monitoring – Contact Plates and Swabbing by trained Microbiologists
• Rental of calibrated air samplers – viable and non-viable
• USP <797> Gloved Finger-Tip Analysis
• Personnel Monitoring
• Personnel Support
• In-Process Monitoring
• Temperature and Humidity Monitoring
• Water Sample Collection for Laboratory Analysis
• Incubation, Analysis, and Reporting per USP <797> Specific Incubation Conditions
• Isolate Characterization and Identification via Biolog™ phenotypic technology