Facility Validation is the foundation to generating accurate and reliable laboratory data. When setting up a laboratory to be compliant with FDA requirements, it is important to determine whether your facility is suitable for testing. This is accomplished through Temperature, Relative Humidity, and Air Handling Validation.
Temperature and Relative Humidity
Validation of the accuracy, uniformity, and stability of temperature and relative humidity within the laboratory are critical to several components throughout laboratory testing. Fluctuations in the temperature and/or relative humidity in the laboratory environment can impact the reproducibility in sample preparation and instrument performance.
Microbiological testing requires a controlled environment. Bacteria and particulates can influence final microbiological sample results. Not only do proper sterilization procedures need to be in place, but the air space in the microbiological environment must meet air flow and particulate requirements to mitigate the potential for cross contamination.