Cold Chain Packaging Testing & Validation
Vérifiez si une configuration définie peut protéger votre charge utile sur l’itinéraire prévu, handling and transit time you expect.
We plan studies around temperature limits, charge utile, expéditeur, réfrigérant ou PCM, conditioning and route exposure. Results apply to the tested configuration.
Test the Packout You Will Actually Ship
Test the assembled shipper, isolation, réfrigérant, charge utile, conditioning and packing sequence—not a component in isolation.
Review the result before reuse if the payload, quantity of refrigerant or other thermal medium, emballage, itinéraire, saison, or duration changes.
- Temperature window
- Allowable payload range.
- Transit duration
- Pack closure to receipt.
- Charge utile
- Géométrie, thermal mass and load.
- Profil ambiant
- Itinéraire, saison, mode and exposure.
- Emballage
- Quantities, positions, conditioning and order.
- Critères d'acceptation
- Limits used to judge the result.
Choose the Right Qualification Stage
Utilisez l’accompagnement DQ pour constituer un dossier de preuves de conformité à la spécification des exigences utilisateur approuvée (URS), OQ to challenge a fixed packout under controlled profiles, and PQ to confirm it through representative field shipments.
Build Evidence Against the URS
Review the approved URS and risks, then plan the evidence needed to assess the design. Formal DQ depends on an approved protocol and the customer's quality system.
- Review requirements and constraints
- Screen insulation, refrigerant or other thermal medium, and the packout
- Define test risks
Challenge the Selected Packout
Test a fixed packout with defined payloads, profiles and acceptance criteria.
- Controlled chamber testing
- Minimum and maximum payloads
- Chaud, cold or seasonal profiles
Confirm Performance on the Real Lane
Confirmez le système retenu au moyen d’expéditions représentatives sur le terrain et des opérations de manutention habituelles.
- Field protocol and monitoring
- Shipment and deviation records
- Requalification planning
Important: Les essais en laboratoire peuvent étayer la DQ et l’OQ, mais ne remplacent pas les expéditions réelles nécessaires à la PQ. La stabilité du produit et la responsabilité réglementaire restent du ressort du propriétaire du produit.
Laboratory Capabilities for Your Project
The center supports material and PCM characterization, environmental exposure, packout assembly and temperature monitoring. Confirm method, equipment and criteria in the protocol.
Matériel & PCM Characterization
Phase-change and material work using differential scanning calorimetry, precision weighing and viscosity measurement.
Environmental Simulation
Fixed or changing ambient conditions against a defined profile and duration.
Vérification de l'emballage
Complete packout assembly, conditionnement, payload arrangement and monitoring positions.
Laboratory Instrumentation
Equipment shown includes DSC, precision balances, viscosimètres, haut- and low-temperature chambers and climate chambers. Confirm required equipment before testing.
What Do You Need to Learn Before Shipping?
Cette configuration peut-elle maintenir la charge utile dans les limites prévues pendant l’itinéraire et la durée envisagés?
- Which shipper, insulation and refrigerant should be tested?
- Which payload or sensor position is limiting?
- How do conditioning and ambient exposure affect performance?
- How long does the tested system remain within limits?
- Are seasonal packouts or requalification needed?
How Your Test Moves From Requirement to Result
Validez chaque étape avant les essais afin que les données répondent à la question d’expédition.
- 01
Share Requirements
Provide limits, charge utile, voie, durée et critères.
- 02
Agree the Protocol
Confirm profiles, conditionnement, sensors and repetitions.
- 03
Lock the Packout
Document components, quantités, orientation and preparation.
- 04
Run the Profile
Record payload-simulant and ambient temperatures.
- 05
Review Results
Compare data with criteria and record deviations.
- 06
Plan Field Use
Define field PQ and requalification triggers.
What You Can Receive for Technical Review
Agree deliverables before testing. They may include the protocol, packout record, time–temperature data and a report with results, deviations and limits.
Review Thermal Test Profiles & RapportsExaminer les documents techniques & Rapports
Approved Test Protocol
Scope, responsabilités, équipement, profils, payloads and acceptance criteria.
Packout Record
Component list, conditionnement, quantités, placement and packing sequence.
Time–Temperature Data
Raw records, graphs, monitoring locations and relevant equipment identification.
Rapport d'essai
Méthode, résultats, écarts, comparison with criteria and stated applicability limits.
Questions Customers Ask Before Testing
Use these answers to prepare the test request.
What should I provide to request a test?
Send temperature range, charge utile, condition de départ, itinéraire, mode, durée, saison, current packaging and acceptance criteria.
Can I use an existing result for a different box or payload?
Pas automatiquement. Review changes to the container, isolation, refrigerant or other thermal medium, conditionnement, charge utile, emballage, durée, or ambient profile before reuse.
Do I need DQ, OQ or PQ?
La DQ consigne les éléments de preuve au regard de l’URS approuvée et peut inclure des essais; OQ challenges a fixed configuration; PQ uses representative field shipments. Required stages and approvals depend on the product, protocol and quality system.
How is the ambient test profile selected?
Utiliser l'itinéraire, saison, mode, vivre et gérer les risques. Prefer logger records or dummy shipments; otherwise use an authorized profile supported by risk assessment.
What determines the qualified duration?
Compare payload temperatures with the agreed limits. Read duration with the tested payload, conditionnement, réfrigérant, ambient profile and criteria.
Testing Methods and Reference Guidance
WHO or ISTA guidance may shape the study. Agree the method, scope and criteria; a reference does not certify the system.
Tell Us What You Need to Protect
Limites d'envoi, charge utile, itinéraire, mode, durée, saison et emballage. We can discuss design screening, chamber testing or field PQ.