Dryce - Qualification Report

Qualification Report: The Science of Thermal Certainty.

Go beyond packaging — choose a validated system. Our reports provide granular data and replicable methods that describe the entire qualification process, enabling the creation of virtual models (Digital Twin) perfectly aligned with real-world results.

Methodological rigour and scientific validation

Through tests conducted according to AFNOR thermal profiles, we map the real behaviour of systems to guarantee absolute stability between +2°C and +8°C. This data ecosystem provides the scientific foundation for the Virtual Cool Chain, eliminating uncertainty and ensuring full replicability of performance on a global scale.

Data uncertainty and regulatory risk

In pharmaceutical transport, the lack of precise data on packaging performance represents an extremely high risk. Many solutions on the market offer partial or non-replicable validations, making it impossible to predict how the container will react to thermal stresses different from those of the test. Without a complete description of the process (refrigerant masses, thermal inertia, insulation), it is impossible to build reliable virtual models, forcing companies to conduct continuous and costly physical tests for every new route or climate variation.

Integrated Validation and Virtual Models

Dryce solves the problem through a Qualification Report that acts as a true thermodynamic "instruction manual". For CB25 and CB52 systems, we document the stability of behaviour under extreme stress, demonstrating the effectiveness of the insulation and the optimal exploitation of refrigerant masses (Green and Blue Ice). The granular analysis of real data allows virtual packaging models to be validated: by comparing physical results with simulations, we create a digital model (Digital Twin) that enables thermal performance to be predicted on any route. This approach ensures maximum insensitivity to external peaks and guarantees that the drug always remains within the safe range, making qualification a dynamic, replicable and scientifically unassailable process.

Questions about the Dryce solution

Why do you test packaging without product simulants?

We choose not to introduce substances that simulate the product in order to eliminate any benefit derived from the thermal inertia of the payload. This allows us to measure the pure performance of the packaging system under "worst-case" conditions.

What is meant by experiment replicability?

It means that our methods and data are detailed enough to allow Quality managers to obtain the same results by repeating the test, providing a solid basis for every inspection audit.

How is this data used for the Virtual Cool Chain?

The real results of the Qualification Report serve as the "anchor of truth" for our software simulations. If the virtual model faithfully replicates the documented physical test, it can then be used with confidence to simulate shipments on routes that have never been physically tested.

We innovate the present,
we preserve the future

By choosing Dryce, you will choose tailor-made solutions that reflect your brand and company in an ecological and innovative way.

Contact us now to discover all customisation options!