LexaMed offers an environmental monitoring program that integrates many of our core competencies into a comprehensive program to address and support the requirements of our client base. The program can be applied to medical facilities operating in an ISO 8 manufacturing area to aseptic pharmaceuticals manufacturing conducted in ISO 5 environments.The program can be adopted in total or individual elements can be applied to your specific application. The program includes the following elements:
- Environmental Monitoring Master Plan. An experienced LexaMed consultant can work with you to design a program for your needs per ISO 14698-1:2003, including monitoring frequency, monitoring site selection, clean/disinfection results and location, etc. Alternatively, the LexaMed consultant can audit your existing program against current regulatory requirements and expectations as well as best industry practices.
- Contract Monitoring. A trained LexaMed associate will conduct viable and/or non-viable monitoring at your site. We can provide the equipment for you to sample at your site. We can incubate, enumerate, and compile data on samples.
- Organism Identification. LexaMed can determine the colony morphology, perform gram stain, identify to species level, provide digital photographs of colony and cellular morphology, create a customized “Microbial Isolate Atlas”, and provide data analysis, evaluation and tending.
- Create & Provide High Concentration Stocks of Predominant Isolates. We can create customized stock suspensions for use in Disinfectant Efficacy studies, cleaning studies and validation studies. We can maintain your culture isolates in-house for future use. A shelf life can be established for your customized suspension via a stability program.
- Create & Provide Low Concentration Stocks of Predominant Isolates. We can create customized stock suspensions for use in Growth Promotion and Recovery studies. A shelf life can be established for your customized suspension via a stability program.
- Microbial Isolate Resistance Evaluation. This includes disinfectant resistance and sterilant resistance (D-value) – Steam, Ethylene Oxide, Disinfectant, Dry Heat, UV, and others. We can create custom Biological Indicators (BIs) from spore isolates.