#thermal mapping

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Temperature Mapping of Warehouses vs Vehicles

While there are many temperature monitoring products on the market today, they are not effective if they are not deployed properly. Door openings, hot and cold spots, shelf height, ventilation systems, and other elements can all affect how measurements are recorded and analyzed in the field. And, while, previous articles have talked about the risk associated with cold chain logistics and storage, temperature mapping is one of the more important methods for determining the cause of product quality issues.

Temperature mapping is based around three areas: compliance regulations, quality / safety issues, and energy efficiency.

What is temperature mapping?

 The purpose of temperature (or thermal) mapping is to ensure all areas of the process equipment or storage area achieve the required temperature. The outcome of the temperature map is to understand the temperature distribution, and to define hot or cold spots of the process equipment or storage area. This takes into account the temperature & density of humidity of warehouses for the storage of environmentally sensitive products. You should note that regulations and guidelines state that thermal equipment needs to be qualified (IQ-OQ-PQ), storage areas and vehicles need to be temperature mapped, and both need to be monitored with temperature sensors installed at locations where worst case scenarios may appear (hot and cold spots).

Types of temperature mapping

1) Temperature Mapping for Warehouses

The purpose of a temperature warehouse mapping study is to evaluate storage conditions, analyze temperature and humidity distribution, and identify critical zones inside the warehouse.  The resulting study will show:

Variation of temperature at a single point or across an area

The impact of interventions, such as door openings or power failures

Identification of hot and cold spots within a defined area

Length of time of any temperature excursions

Ventilation  and stock layout issues

All warehouses should be temperature mapped to determine the temperature distribution under extremes of external temperature. Mapping should be conducted in any new facility, facility expansion, or after any significant modification to the site, stock layout, or heating system.

2) Temperature Mapping / Qualification for Vehicle Validation

Qualification refers to checking that a product, service, equipment or system meets requirements and specifications and that it fulfills its intended purpose. It has always been the responsibility of the carrier to ensure the safety, quality and efficacy of the product during shipping operations. Temperature mapping documentation demonstrates that this quality status is continually maintained and further supports the company from a liability perspective. However, under today’s strict regulations and guidelines for transporting pharmaceutical product, maintaining current and ongoing documentation of storage area qualification is no longer optional. Current guidelines not only require temperature mapping, but they also require temperature monitoring with sensors installed where worst case scenarios may occur (doors, vents, etc).

A Qualification exercise for vehicles collects the following information:

Summer and  winter mapping data

External ambient temperature

Empty and loaded product data

Cool down time verification

Hot and cold spot identification

Power failure tests

Test results impact on product to incidents like door opens

Shipment and packaging qualification tests

It is necessary that vehicle qualification be performed by a disinterested third party. Temperature mapping for vehicles includes validating transit-sized delivery vehicles to full size trailers.