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As a third-party logistics (3PL) provider serving the pharmaceutical and biotech industry, your facility plays a critical role in maintaining product safety and regulatory compliance. One of the most important ways to demonstrate your commitment to quality—and win client trust—is by conducting a temperature mapping study.
Whether you are preparing for your first study or requalifying a warehouse, proper planning can help you avoid delays, maintain operations, and ensure your results meet client and regulatory expectations.
When 3PLs Should Conduct a Mapping Study
You should plan to conduct a temperature mapping study when:
- Opening a new warehouse or storage area
- Changing the layout or racking configuration
- Making updates to HVAC, insulation, or environmental control systems
- Preparing for a new client contract or audit
- Experiencing seasonal temperature extremes that may affect internal conditions
Routine requalification is recommended every three years, or more frequently for highly critical areas or after significant changes to the facility or operations.
How to Prepare Your 3PL Facility for a Mapping Study
1. Identify Client and Regulatory Requirements
Different clients may have different expectations, especially if they are distributing globally. Make sure you understand their requirements (e.g., WHO, USP <1079>, FDA 21 CFR Part 211, EMA) so the study meets both their needs and industry standards.
2. Conduct a Risk Assessment
Work with your Quality and Operations teams to evaluate storage zones, product types, temperature sensitivity, and known risk areas (e.g., dock doors, HVAC vents). This will help determine sensor placement and the study’s scope.
3. Review HVAC and Monitoring Systems
Before your study begins, verify that your HVAC systems, temperature monitoring devices, and alarms are functioning correctly. A temperature mapping study will validate your environment—but it cannot fix system failures.
4. Align with Your Mapping Partner Early
A qualified provider will help you develop a test protocol, define worst-case scenarios, and plan around your operational hours. Involving them early can help you avoid disruptions and meet your timeline.
5. Train and Inform Your Warehouse Staff
Make sure your team understands the study timeline and protocol. During the mapping period, normal activities like opening bay doors or moving pallets could affect temperatures so coordination is key.
Common Mistakes 3PLs Should Avoid
- Last-Minute Scheduling: Sponsors may require documentation quickly—build temperature mapping into your planning timeline.
- Inconsistent Environmental Controls: Avoid changes to airflow, equipment usage, or loading dock access during the study.
- Poor Documentation Practices: Clients and regulators expect not only raw data but also clearly documented study protocols and results.
What Happens During a Mapping Study
Most studies last 72 hours to 7 days and involve placing calibrated data loggers throughout the space, including hard-to-reach areas like top shelves or corners. Afterward, your provider will analyze the data to confirm whether the space maintains uniform conditions within the specified range.
Partner with a Team That Understands 3PL Needs
At Performance Validation, we understand the pressures 3PLs face from sponsors and regulators. Our team delivers efficient, accurate mapping studies tailored to your warehouse layout, compliance requirements, and client expectations. We offer multiple equipment solutions to fit a wide range of mapping scenarios and utilize a digital validation platform that helps eliminate documentation errors and ensures the process is executed correctly from start to finish.
