Air ThermoDirect: Quality by design
How controlled process – not packaging alone – delivers repeatable 2–8°C thermal integrity in pharmaceutical airfreight
1. Introduction
Consistent quality is the foundation for patient safety and the basis for supply chain resilience. GxP and GDP compliance – audited by customers and regulators alike – is the non-negotiable floor beneath any pharmaceutical cold chain; a single temperature excursion can scrap product and trigger a recall.
A cold chain process must be designed to operate both across borders and within local contexts, meeting national and regional GxP and customs requirements while following a single global quality standard. Over the years the regulatory bar has risen, and regulators now take a zero-tolerance stance on deviations from GDP, even during active disruption.
To stand up to that level of control and validation, a supply chain needs to be designed by specialists and backed by a provider with the scale to deliver end-to-end control – from tarmac cooler infrastructure, aircraft control and advanced thermal packaging to SOP governance and control-tower monitoring.
Among DSV's cold chain solutions, Air ThermoDirect is built on a designed control standard – process design and process adherence – rather than packaging performance or general GDP compliance alone.
What Air ThermoDirect is
Air ThermoDirect is designed as a higher-control thermal logistics model that combines validated thermal protection with DSV-operated temperature-controlled airport infrastructure and qualified execution partners working to a solution-specific standard.
Air ThermoDirect combines four elements:
- DSV’s own healthcare air network (AirDirect)
- Access to DSV-operated or DSV-controlled ground-handling (GHA) operations
- Modular passive thermal packaging
- An end-to-end process and control framework
The quality position
Quality in Air ThermoDirect is created by system control, not by packaging alone. GDP and ISO standards are foundational, but they are baseline. Air ThermoDirect adds a higher-control operating layer, executed through dedicated facilities, defined handling rules, vetted partners, and lane qualification. The result is less uncontrolled exposure, less execution variability, and greater repeatability.
The facility control standard
Before a ground-handling facility can handle Air ThermoDirect freight, it must meet a defined set of requirements. These controls are specific to the solution and are verified, not assumed.
Category | Requirement |
|---|---|
Storage | Short-term storage up to 48 hours in a 2–8°C environment |
Temperature control | A 2–8°C storage and handling area for ULD break-down and build-up |
Temperature control | Summer and winter calibration of all temperature-monitoring sensors |
Temperature control | Monitoring devices at low, medium and high positions in each chamber, calibrated accordingly |
Temperature control | Temperature records extracted at regular intervals, with all read-outs accounted for the period (manual extracts accepted on this basis) |
Security | Active video surveillance at every location used for Air ThermoDirect |
Pest control | Active pest control by an external provider, with each treatment recorded |
Governed exception to temperature control: Where no 2–8°C staging area is available, break-down may take place in a 15–25°C environment – but only when the cargo has been held at 2–8°C up to that point, is ready for immediate pick-up, and a reefer vehicle is positioned at the nearest gate. This exception is governed by a strict, pre-validated SOP.
3. Air ThermoDirect’s quality: validation, process and evidence
3.1 Validation and qualification backbone
The model has been tested and has passed across multiple use cases, not under a single ideal condition.
- Validation and qualification testing completed with multiple top pharmaceutical manufacturers
- DSV internal qualification complete, comprising 12 test runs
- Test matrix covering both typical-mass and low-mass profiles
- All qualification runs passed
- Maximum-load qualification demonstrating control for six 75 kg skids; minimum-load qualification demonstrating control for four 75 kg skids
Taken together, this evidences repeatability across different load profiles, different directions, and repeated operational cycles – not performance under one favourable condition.
3.2 Thermal quality evidence
In a validation workbook from a top-10 (by revenue) multinational healthcare client, the test setup included:
- Six pallet-level temperature-monitoring sensors
- Real-time outer-carton monitoring
- Multiple inner-carton, product-level sensors
- Milestone tracking across origin handling, thermal application, ULD build-up, destination handling and delivery
Across DSV internal qualification, all tests met the acceptance criteria for maintaining 2–8°C, demonstrated across repeated runs rather than a single shipment. A second top-10 healthcare client validation also passed, using milestone-based shipment tracking and logger-based temperature review across multiple trial moves.
The evidence is therefore not simply “passed.” It is repeated, demonstrated maintenance of 2–8°C – across multiple sensor positions, multiple load densities, multiple directions, and through operational milestones rather than only static chamber conditions.
3.3 Process control quality
The quality result is a function of process architecture. Air ThermoDirect is not handled through a standard airport chain; it is controlled through:
- DSV-operated tarmac facilities
- Direct transfer between controlled space and aircraft
- Controlled thermal application and ULD build-up
- Controlled storage before and after handling until the cargo is picked up
- A defined break-down process at destination in a controlled environment
- Prequalified handling partners
- Milestone-based monitoring
In the trials, performance was evaluated across each process milestone – truck unloading, thermal application, ULD build-up, loading to aircraft, departure and arrival, unload, cooler recovery, and delivery simulation – not at a single checkpoint.
3.4 Compliance above the baseline
GDP and GxP compliance form a zero-tolerance foundation. Air ThermoDirect is executed through an additional layer of solution-specific control: qualified airports, dedicated handling procedures, direct tarmac access, controlled build-up and break-down, and partner execution standards tailored to the thermal solution. This makes execution more controlled, more repeatable, and less dependent on general airport handling conditions than standard handoff-based models.
3.5 Proof points
Across the most recent validation programs:
Measure | Result |
|---|---|
Sensors deployed across recent validation programs | 460 |
Logger readings collected | Over 150,000 |
Product-level readings within 2–8°C | 100% |
End-to-end qualification shipments with zero product-impacting deviations | 22 |
Average tarmac exposure, aircraft-to-cooler transfer | 18 minutes (vs. even up to 5+ hours of uncontrolled staging on standard commercial options) |
Monitoring layers applied | Pallet-level, carton-level and real-time |
Process tracking | Milestone-based across origin, airport, flight, destination and delivery simulation |
4. Case study: 2–8°C performance qualification using low-mass pallets
Anonymised customer case study – top global pharmaceutical manufacturer
Executive summary
DSV completed a controlled thermal performance qualification for a top global pharmaceutical manufacturer using exceptionally low-mass test skids of approximately 70–75 kg each. The test challenged Air ThermoDirect under a conservative low-thermal-mass profile across controlled transatlantic air lanes.
The programme consisted of six shipment cycles between Luxembourg and Huntsville. Each cycle included two ULD positions: one minimum-load ULD of four low-mass pallets and one maximum-load ULD of six low-mass pallets. Each skid was protected with an individual skid thermal, and each ULD with a six-sided ULD thermal system.
All evaluated minimum-load and maximum-load configurations passed. The test report recorded the six maximum-load tests and six minimum-load tests as meeting acceptance criteria, demonstrating that the process maintained 2–8°C under the tested configuration.
Why this test was intentionally conservative
The qualification was designed around a low-mass pallet profile because thermal mass is a key stabilising factor in temperature-controlled transport. A fully loaded commercial pharmaceutical pallet typically carries more mass – and therefore more thermal inertia – than the test skids used here. By using pallets of only approximately 70–75 kg, the protocol reduced the natural thermal buffer and created a more demanding challenge.
The test therefore did not prove performance under ideal cargo conditions. It evaluated the solution against a low-buffer configuration intended to represent a worst-case thermal-mass scenario.
Test design
Test element | Minimum-load ULD | Maximum-load ULD |
|---|---|---|
Pallets per ULD | 4 pallets | 6 pallets |
Approx. pallet/skid mass | 70–75 kg each | 70–75 kg each |
Skid protection | Individual skid thermal | Individual skid thermal |
ULD protection | Six-sided ULD thermal | Six-sided ULD thermal |
Temperature acceptance range | 2–8°C | 2–8°C |
Result across six cycles | Pass | Pass |
Protocol rigour and sensor placement
The protocol pack documented participant review and signature, SOP references, monitor operation, monitor placement and assignment, recovery, and shipment milestone capture. Sensor placement was defined across pallet/skid positions and external ULD locations to evaluate both protected cargo temperatures and environmental exposure points across the two load configurations.
Temperature performance evidence
The qualification report included individual temperature graphs with process milestones for each test. The examples below show monitored temperatures remaining within the defined 2–8°C range through the key airside milestones – aircraft loading, departure, arrival, cargo-hold opening, and transfer back to cold-room control.
Additional test examples
The following examples show repeated performance across further cycles, load configurations and the return direction (LUX–HSV).
Controlled end-to-end operating model
A critical differentiator of Air ThermoDirect is the controlled operating model. The solution is executed through DSV-managed temperature-controlled infrastructure, defined tarmac handling procedures, controlled ULD build and recovery, and DSV-controlled aircraft operations. This reduces exposure to the uncontrolled handoffs common in traditional airfreight models that rely on third-party tarmac facilities and fragmented operational control.
Control point | Air ThermoDirect operating advantage |
|---|---|
Origin handling | Controlled cooler environment and defined SOP execution |
ULD build | Individual skid thermal plus six-sided ULD thermal protection |
Tarmac movement | Reduced ambient exposure through a direct tarmac/cooler interface |
Aircraft operation | DSV-controlled air network with defined cargo-hold handling |
Destination recovery | Controlled transfer from aircraft back to cold-room environment |
Governance | Documented protocol, milestones, sensor assignment and recovery records |
Result summary
Across the six qualification movements, the test report recorded all minimum-load and maximum-load configurations as passing. The outcome demonstrated that the combined DSV process, thermal covers, controlled tarmac handling and aircraft operating model maintained 2–8°C even with low-mass skids that provided far less thermal inertia than typical pharmaceutical freight.
The low-mass test design created a rigorous worst-case challenge. Passing both the 4-pallet minimum-load and 6-pallet maximum-load configurations supports Air ThermoDirect as a controlled, repeatable and scalable 2–8°C model for pharmaceutical airfreight.
Commercial and operational significance
The case study supports Air ThermoDirect as an alternative to conventional active-container or passive-packaging models for applicable 2–8°C pharmaceutical airfreight lanes. Because the solution is already executed daily and weekly across the DSV network, the qualification reinforces both technical performance and operational scalability.
The key value is control. DSV is not purchasing capacity from disconnected providers and relying on the handoffs to perform. The model combines tarmac-based cooler infrastructure, aircraft control, thermal application, SOP governance and temperature monitoring within one managed operating environment.
5. Conclusion
Air ThermoDirect quality comes from:
- Validated thermal performance
- Dedicated temperature-controlled tarmac infrastructure
- Defined process
- Qualified partners
- Milestone-based visibility
- Repeatable lane execution
The quality performance demonstrated across internal qualification and top-pharma validation supports Air ThermoDirect as a higher-control operating model, designed to deliver repeatable thermal integrity under real airport handling conditions.
Sources
- Deloitte, Spring 2025 European CFO Survey: https://www.deloitte.com/us/en/insights/topics/business-strategy-growth/geopolitical-risk-cfos-europe.html
- J.P. Morgan Research, Red Sea shipping analysis: https://www.jpmorgan.com/insights/global-research/supply-chain/red-sea-shipping
- McKinsey & Company, life sciences capital-projects outlook: https://www.mckinsey.com/industries/life-sciences/our-insights/the-speed-to-market-imperative-for-life-sciences-capital-delivery
- DSV internal qualification and top-pharma customer validation programmes (2026).
