November 29, 2017, Lakewood, Colorado – The changing weather can greatly impact certain areas of your warehouse, and these temperatures changes may affect 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 times so that your products are not potentially damaged?
Mesa’s Compliance and Validation Services experts will work with you and your team to review every potential variable that may impact the viability of your product. We will determine the risk factors by considering all HVAC activity and control, loading dock location and activity to develop criteria for and execution of a thermal mapping.
We will also 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. The data logging system will be determined, a diagram will be developed, and the length of the study will be defined. Finally, Mesa experts will place the data loggers in the appropriate locations throughout your warehouse and collect the resulting data.
By performing regular mappings of your warehouse, you can greatly reduce the risk to your products by varying temperatures when the seasons change.