Temperature Mapping Frequently Asked Questions

A: Temperature mapping is the process of systematically recording temperatures throughout a specific area to ensure that conditions meet safety and compliance standards.  

A: Temperature mapping can be crucial to ensuring product integrity across your supply chain. It is required for any space allocated for storing and handling products with a specified storage temperature requirement. This could include laboratories, freezer or cold rooms, temperature-controlled storage areas, quarantine areas, and even receiving and loading bays

A: Maintaining correct temperature is essential to ensuring the stability and efficacy of pharmaceuticals. Improper storage can result in product degradation, reduced efficacy, and potential risks to patients. Temperature mapping helps the pharmaceutical industry maintain uniform and appropriate conditions for safety and regulatory compliance. 

A: Maintaining correct temperature is essential to ensuring the stability and efficacy of pharmaceuticals. Improper storage can result in product degradation, reduced efficacy, and potential risks to patients. Temperature mapping helps the pharmaceutical industry maintain uniform and appropriate conditions for safety and regulatory compliance. 

A: Key regulatory standards include guidelines from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). Additionally, compliance with Good Manufacturing Practices (GMP) is required. 

A:  Among the equipment essential to the temperature mapping process are temperature data loggers or sensors, calibration equipment for ensuring accuracy, and if humidity control is a factor, specialized humidity sensors are required. Data loggers should be able to record data at set intervals and be durable enough to withstand the specific environmental conditions of your storage areas. 

A:  It’s essential to establish a baseline for storage conditions. Temperature mapping should be performed again after any significant changes to the storage area (like changes in HVAC systems, relocation, or after major repairs), and then periodically as part of ongoing validation processes. It’s common for Transcat’s Solutions team to re-map a customer’s environment every one to two years - or in accordance with regulatory requirements. 

A:  Among the most common challenges when temperature mapping in a large or complex storage area include ensuring sufficient sensor coverage, data management and analysis, and maintaining minimal disruption to operations. Transcat will work with your team to understand your processes and minimize disruption.  

A:  If significant variations are detected, the Transcat team will recommend adjustments to correct them, such as recalibrating your HVAC systems, altering the layout of stored product to improve airflow, or adjusting the placement of product away from hotspots or cold spots. Follow-up mapping may be required to ensure that conditions have stabilized.

A: Temperature Mapping includes:  

• Strategy: Determining the scope of the area to be mapped, selecting the appropriate sensors, and planning a sensor layout strategy.  

• Placement: Sensors are positioned throughout the area to capture temperature variations across varying locations and heights. 

• Data Collection: Data will be recorded over a pre-defined period that will include both operating and non-operating conditions. 

• Data Analysis: The team will evaluate the data, identify any out-of-spec conditions, and assess the uniformity and stability of the environment. 

• Reporting: The team will then document the findings, methodologies, and any recommendations for improving temperature control.

Partnering with Transcat Temperature Mapping Team unlocks the potential to optimize manufacturing efficiencies in your operations. Contact us today for a tailored solution for your unique needs.