All You Need to Know
about Qualification, Validation & Mapping

Qualifying a refrigerator, freezer or ULT-freezer is a rather simple process:

• Refrigerators are standard equipment purchased as stand-alone devices. Compared to more complex and customized pieces of equipment (like warehouses or transport boxes), the risks are limited.
• Refrigerators are operated in a controlled room temperature environment. The risks are limited to the following: air outlet blockage, power outage, wrong loading and door opening.

Companies usually operate many refrigerators, freezers, ULT-freezers or incubators. Therefore, qualifications are typically done as a fleet or farm qualification, which is performed as follows:

1. Cluster the fleet of refrigerators into homogeneous groups. For example, cluster them by the same supplier, same model and same size.
2. For each group apply the V-Model and work out:
   • User Requirement Specification: document temperature range and description of application.
   • Risk Analysis: evaluate placement, power supply and operational aspects like frequency and lengths of door opening, loading and cleaning patterns.
   • Design Specification: For each cluster of refrigerators, define exact purchased model and installation instructions (avoid blockage of air flow compressor, power supply).
   • Operational Qualification: One refrigerator from each cluster is mapped in detail following WHO guidelines in an empty status.
     
3. Perform the design qualification for one refrigerator per cluster group by checking: is it the right model and does the air flow and power supply comply with the specifications?
4. Since one refrigerator per cluster group has already been mapped, it is now possible for the remaining refrigerators of the same group to leave out the "dry run" qualification and to directly perform a performance qualification (mapping of the full refrigerator) during normal operation. Of course, the mapping should be performed with data loggers which are calibrated and compliant.

Qualifying warehouses, cold rooms, and storage facilities is much more complex than refrigerators because they are not off-the-shelf products. Although built with standard components, they are engineered facilities with individual designs, layouts, air flows, doors and control systems. There are many different types of warehouses, cold rooms, or storage facilities with different temperature ranges and applications which have major implications on the qualification and mapping strategy.

Warehouse 

• Type: Large room/hall with open space or high racks 
• Typical Temperature Range: 2-8°C or 15-25°C.
• Implications on Qualification & Mapping: Warehouses typically have outer walls directly exposed to ambient conditions and seasonal effects. Insulation of the building and the absence of windows and other openings are vital. Since there is influence from ambient conditions, winter and summer mappings are necessary. Same applies for the loading dock.

Cold Room 

• Type: Smaller room/hall with open space or racks.
• Typical Temperature Range: 2-8°C or -20°C
• Implications on Qualification & Mapping: Cold rooms are typically rooms inside a building and the walls have no direct exposure to ambient conditions and seasonal effects. Often there is no need to perform a separate winter and summer mapping.

Other Facilities and Loading Docks

• Type: Small room with racks
• Typical Temperature Range: 15-25°C or 2-30°C or <40°C
• Implications on Qualification & Mapping: The framework and complexity of the qualification and mapping of other facilities will be defined by the stored/handled products, their required label condition and their length of stay within the facility.

Taking all of this into consideration leads us to the question of how to structure the qualification. In most cases the planning and building phase is delegated to specialized engineering firms. Still the documentation of the qualification and mapping must be consistent in following these steps:

1. Define User Requirement Specifications describing the purpose of the warehouse, cold room, or storage facility.
2. Perform a detailed Risk Analysis describing all structural and operational risks
3. Define high-level design requirements (floor plan, equipment for temperature control, power supply)
4. Perform a simple design qualification: Has the facility been built as planned?
5. Perform an operational qualification: Mapping of the empty facility in winter and summer condition (perform only one mapping if seasonal effects can be fully excluded per the table above).
6. Conduct the performance qualification: Mapping with full load during normal operation.

Companies typically operate many trucks or vans in one fleet. Therefore, truck and van qualifications are typically performed as a Fleet Qualification as follows:

1. Cluster the fleet of trucks or vans into homogeneous groups. For example, criteria can be the same brand, same model, same layout, same type and version.
2. For each group apply the V-Model and work out:
   • User Requirement Specification: Temperature range and description of application (lengths of trip, expected extreme ambient conditions, winter/summer profiles)
   • Risk Analysis: Power supply and operational aspects like loading/unloading, frequency and lengths of door opening.
   • Design Specification: For each type, define the exact purchased model and set-up.
3. Perform the Design qualification for one truck/van per cluster group by simply checking the few points defined: Is it the right model with the exact same configuration and application range?
4. Since one truck or van per cluster group has already been mapped, it is now possible for the remaining trucks/vans of the same group to leave out the "dry run" Qualification and to directly conduct a Performance Qualification (Mapping of the full truck) during normal operation. Of course the mapping should be performed with data loggers which are calibrated and compliant.

Qualifying a transport box or container is much more complex than qualifying a refrigerator. Since the object to be qualified moves around in uncontrolled environments, we first need clarity on the planned purpose of the box and container by answering the following two questions: is it a road, air or ocean shipment? How long will the shipment take? The following picture shows an overview of different transport modes:

When performing a qualification of a transport box or container, another challenge is to come up with a realistic temperature profile to test against. How long will the shipment take? What temperatures will be expected at origin, on the way and at destination? Are there seasonal changes? There are two approaches to define the correct ambient temperature profile:

1. Use empirical data: A common approach is to classify the shipment into sections (origin to hub; hub to hub; hub to destination), or to cluster them by assigning climatic zones to the sections (e.g. cold, moderate, warm, hot) and to define extreme seasonal weather changes (e.g. cold to hot, hot to cold). The difficulty with this approach is to define the specific length of each shipment section (how many hours the product has in each section) and estimate a realistic average temperature within each climate zone.
2. Map the ambient temperature: In reality, this is the best way is to measure the temperature of a specific route. This is done by performing several seasonal shipments and collecting the temperature data from each of the shipments. Afterwards the average temperatures from each shipment section are calculated and used. This is also the most elaborate method.

Last, but not least, there is a significant difference between passive insulated boxes using phase change materials (PCM) with insulation and active heating/cooling containers. From a qualification perspective the difference of the two technologies is not so much performance, but rather the risks which need to be considered. The following explains the differences between the two technologies including a high-level risk appraisal.

Passive Insulated Box

• Technology Used: Thermal Packs filled with Phase Change Material (PCM) having a defined melting point (5°C melting point for 2-8°C shipments) and insulation materials such as Vacuum Panels.
• Process at Origin: Phase Change Material (PCM) must be pre-conditioned and must have the right temperature when loaded. To ensure the promised performance the box must be built-up exactly as designed: product surrounded by one layer (minimum) of PCM, surrounded by one layer (minimum) of Vacuum Panels, held together by a cardboard box.
• Process During Shipment: Ensure the shipment is not exceeding the defined shipment lengths. For example, if the box is built to keep temperature for 72 hours, a longer shipment time could result in damaging the goods.

High-level Risk Appraisal: The highest risk is a packaging error (e.g. wrong conditioning of PCM). As soon as a shipment is on its way, the solution is very stable and there are only minimal risks.

Active Container

• Technology Used: Insulated container with air ventilation, heating and cooling unit (typically compressor cooling and electrical heating) and  battery including a charging unit.
• Process at Origin: The battery must be charged before loading and the right set temperature must be defined.
• Process During Shipment: Re-charge the unit at hubs and airports. Prevent manipulation of the set temperature or door openings.

High-level Risk Appraisal: While active containers are very easy to load, there are significant risks during shipment involving human error (e.g. no recharging) and mechanical failure. Heating and cooling containers consist of hundreds of mechanical and electronic components which have the potential to fail.

As soon as the box or container has been chosen, and the intended purpose is defined, qualification can start by applying the steps of the V-Model:

1. Define Specifications of the transport box or container by describing the type transport box, loading volume, set temperature, shipment lengths of the transport box or container and specific temperature profiles.
2. Conduct the Risk Analysis describing all operational and technical risks of the transport box or container.
3. Perform Operational Qualification by testing the box in a Climate Chamber (Mapping) running through all defined temperature profiles.
4. Conduct Qualification by performing test shipments (Mapping) on a specified route (e.g. shipment from an extreme cold environment to an extreme hot environment).

Validating a transport route or an entire network starts with qualifying all equipment elements, including warehouses, transport boxes or containers, trucks or vans. In order to be able to find the right subjects for qualification inside a network, a clustering of equipment (e.g. fleet, boxes and container) must be performed. Clustering criteria of the transport elements can be:

• Transport mode (e.g. truck, van, rail, air, ocean)
• Secondary packaging (e.g. no secondary packaging needed, thermal cover, insulated box or active container)
• Truck or van type
• Trip lengths
• Trade-lane (Origin/Destination)
• Climate zones and seasons

After clustering the network into homogeneous groups, a high-level risk analysis can be performed. Cluster-specific risks should be described and evaluated. The higher the risk rating, the more focus must be given when defining mitigation measures. After performing the clustering and risk analysis, each “cluster element” must now be qualified. The following table shows an overview of potential clusters, risks and mitigation strategies: