Transport and storage qualification
Storage and transport qualification ensures uniform temperature and climate conditions. These are a prerequisite for maintaining the quality of your products during storage and the logistics process.
With expertise, measurement technology and documentation, we support you in your quality assurance measures in the area of storage and transport. From individual temperature distribution measurements and metrological tests to project coordination and conceptual design of the qualification project - we provide you with needs-based and cost-efficient service packages.
Qualification of storage areas
The core of the qualification of storage areas is formed by temperature and humidity distribution measurements, in which the performance limits of the air conditioning are determined with the help of additional stress tests. At the same time, critical points are revealed, which can then be permanently monitored and controlled in routine monitoring.
We qualify your cooling and storage areas for you:
- Freezers, refrigerators and room temperature ranges
- Incubators, temperature cabinets and cold rooms
- Warehouses, high-bay warehouses, block storage and the like
Qualification of packaging systems
The qualification of passive temperature control packaging systems is based on the determination of the temperature distribution as well as the testing and determination of load limits.
Metrological testing and documentation of your packaging systems:
- Temperature distribution studies for the packaging system
- Determination of route profiles
- Carrying out winter and summer mapping
- Testing and determination of load limits
- Determination of the suitable packaging system
- Carrying out risk analyses and conceptualising risk management in accordance with ICH Q9
Qualification of transport systems
Testo Industrial Services supports you as a qualification service provider in all quality assurance measures in the area of qualification. We qualify your actively air conditioned transport systems for you. Vehicles, containers and trailers for road transport, integral containers or porthole containers for air and sea transport, and single-chamber and multi-chamber systems.
Metrological testing & documentationof your transport systems:
- Climate mapping and temperature distribution studies
- Winter and summer mappings
- Challenge tests / stress tests to test load limits
- Inclusion and testing of route profiles
- Carrying out risk analyses and conceptualising risk management
- Evaluation of routine monitoring positions and critical points
- Design and implementation of standard qualifications ("type qualification")
Our service for you:
- Metrological testing and documentation
- Climate mapping and temperature distribution studies
- Winter and summer mappings
- Challenge tests and stress tests to test load limits (e.g. door opening)
- Carrying out risk analysis and conceptualisation of risk management in accordance with ICH Q 9
- Evaluation of routine monitoring positions and critical points
Your advantage: Our competence
- Expertise: Consulting, measurements, project management - our industry-experienced team supports you precisely & in line with your needs
- Technology: The use of our measuring equipment with more than 4,500 references ensures reliable measurement and test results
- Documentation: We hand over the documentation in the audit-proven layout or individually according to customer requirements to you personally on completion of the order
GxP-Services Team
Professional competence, experience and high-precision equipment. The engineers and technicians of our GxP-Services Team are on duty for you throughout Europe.
Success stories
Grieshaber Logistics Group AG, headquartered in Bad Säckingen (Germany), is an internationally oriented contract logistics service provider. The aim of the project was to draw up a holistic concept for GSP compliance together with the customer, to establish this and to implement the qualification and validation measures derived from it. Learn more about the planning and implementation of the GxP compliant qualification and validation of the logistics centre in our reference.
Referenz Grieshaber Logistics Group AG
Know-how
With Good Storage Practice (GSP) and Good Distribution Practice (GDP), the high quality requirements for the manufacture of medicinal products during storage and transport are consistently continued. Our two-part technical article illustrates the implementation of risk-based qualification measures for storage and transport.
