What impact does the HVAC system have on your warehouse storage conditions? Does the changing weather have a greater impact on certain areas of the warehouse? Are the temperature changes affecting your product? Will temperature mapping your warehouse only once provide enough information to understand the storage conditions in the warehouse during the coldest time of the year (high use of heating) and warmest time of the year (high use of A/C) or should your warehouse be mapped multiple time so that your products are not potentially damaged.
Mesa’ Compliance and Validation Services will work with you and your team to look into every potential variable that may impact the viability of your product. With your input, we will:
Determine Risk Factors
It is extremely important to look at all HVAC activity and control, loading dock location and activity and many other factors when developing criteria for and executing a thermal mapping.
Establish Acceptance Criteria
The temperature and relative humidity acceptance criteria for each product is determined by testing conducted per the FDA Guidance Document – Stability Testing of New Drug Substances and Products, or similar guidance.
Determine Data Logging System
Data loggers used should have sufficient memory to record the entire study and a valid, NIST-traceable 3-Point Calibration. The calibration points should be based on the range of the area(s) that will be mapped.
Develop Area Diagram
Measure the length, width and height of the area to be mapped. Develop a diagram including shelving, racks, doorways, loading docks, heating/cooling equipment and the specific placement of each data logger.
Define the Length of the Study
A minimum of 7-10 consecutive days of mapping for warehouses and other ambient storage areas should be conducted. For temperature-controlled areas (i.e. incubators, refrigerators, freezers, cold rooms), a 24-72 hour temperature mapping study should be performed.
Place Data Loggers
Detail where the Data Loggers should be arranged along the length and width of the area. Label each Data Logger with the unique ID and program each logger to be used to an appropriate sampling interval (5-15 minute logging interval is standard).
Collect the Data
At the end of your study, collect the Data Loggers and confirm the serial numbers and locations against the protocol. Recover the information from the data loggers and perform data analysis.