Why Summer Mapping?
Thermal mapping of warehouse space is an important step in control of the supply chain for life science companies throughout the R&D, manufacturing, and distribution stages. Pre-production materials and finished biopharma products have specific storage conditions that must be measured, documented, and met to be compliant toward current Good Manufacturing Practice.
Those same considerations are important and need to be accounted for when warehouses are constructed or updated. The warehouse has been built based on the design and user requirement specifications. If the warehouse or storage area has any outside facing walls (or ceiling), summer temperature mapping should be performed to evaluate, document and optimize temperature and/or humidity conditions.
Ambient storage warehouses have an acceptable temperature range of 15-30°C or 20-25°C for Controlled Room Temperature (“CRT”), while cold-storage warehouses may operate at a range of temperatures such as 2-8°C, -20°C, -30°C, etc. Industry guidance such as USP 36 general chapter 1079 recommend that a GMP warehouse mapping should run for at least 7 days to capture both static and dynamic conditions including the effects of products being moved, loading bay doors being opened, etc.
Creating a Warehouse Mapping Plan
Some things to consider when developing your plan: Determine what products are planned for storage in the area. Product labels will be important for understanding any temperature, humidity, and light sensitivities and for developing the criteria for the qualification studies.
- Review policies or standard operating procedures (SOPs) that provide direction for the mapping studies. If SOPs/ policies do not exist, look for industry guidance to perform the work yourself or find an independent contractor with the expertise to perform the qualification(s).
- Review the dimensions and height of the storage area and all areas that could potentially be used to hold product.
- Check if racking is permanent or able to be moved. If racking or shelving can be moved, you will want to determine if there need to be demarcation lines added for where the racking could be moved.
- Look for sources that could increase or decrease temperature depending on the season. For example: doors, windows, intake air vents, exhaust vents, fans, equipment or machinery.
- Select sensors that will provide the accuracy needed for the specifications of the area/warehouse. Sensors should be NIST traceable calibrated and cover the range specified by the user requirement specification for the area. Sensors should post-study verified to ensure the sensor’s accuracy did not impact any of the study results.
- Determine sensor placement locations via internal quality management system procedures or industry guidance.
- Confirm the type and quantity of sensors to be used. Wireless dataloggers make sensor placement far simpler than wiring 100ft-200ft thermocouples. Sensors should be securely fastened in place with magnetic clips or zip ties. When possible, position sensors on the inward-facing surface of shelving supports for additional protection. Damaged or dislocated sensors could report invalid values. A best practice is to monitor readings to ensure sensor equilibration before beginning your mapping study.
Run and monitor the mapping study for seven or more days. Seven days is recognized as best practice to map static and dynamic conditions throughout a full week. Once mapping is completed, the data from your validation study will determine where your warehouse’s hottest, coldest and average temperature locations are. This data is useful for ensuring that monitoring sensors are in the best locations to ensure product conditions are being maintained appropriately.
Summer Warehouse Mapping Final Thoughts
Finished pharma products and pre-production materials may be susceptible to temperature and humidity fluctuations. Performing warehouse mapping during the summer months is required to verify and document that your storage conditions are always maintained, even during seasonal extremes.
A compliant 24/7/365 continuous monitoring system in your warehouse allows you to have confidence in the integrity of all products stored within once your validation study is completed.
With the high dollar, or priceless value of many pharmaceutical products and APIs, it is a sound investment to develop and execute a robust seasonal warehouse mapping strategy and incorporate a validated continuous monitoring system for 24/7/365 vigilance.
More questions? Alcami has over 40 years’ experience in Commissioning, Qualification and Validation, and offers service across the US. Contact one of our mapping experts today to discuss your needs today.
