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Transportation and storage qualification by Testo Industrial Services

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Transportation and storage qualification.

Qualification

Transportation and storage qualification

GxP services for storage areas, packaging and transport systems

Both the storage and transport qualifications ensure uniform, constant temperature and ambient conditions. These are a necessary condition for maintaining the quality of your products during storage and the logistic process.

Unstable products and those requiring refrigeration are particularly subject to very strict storage and monitoring requirements in controlled areas in accordance with Good Storage Practice (GSP).

 

At the heart of the qualification of storage areas are temperature and humidity distribution measurements, in which the performance limits of air conditioning are determined with the aid of additional stress tests. At the same time, critical points are identified, which can then be permanently monitored and checked in routine monitoring. We will qualify your refrigeration and storage areas:

  • Freezer cabinets, refrigerators and room temperature areas
  • Incubators, temperature-controlled cabinets and cold storage cells
  • Warehouses, high bay warehouses, block warehouses and similar areas


Our services for your GSP compliance:
 

  • Metrological testing and documentation
  • Climatic mapping and temperature distribution studies
  • Winter and summer mappings
  • Challenge tests and stress tests to check load limits (e.g. door opening)
  • Implementation of risk analysis and conception of risk management in accordance with ICH Q 9
  • Evaluation of the routine monitoring positions and “critical points”
Qualification of storage areas by Testo Industrial Services

The qualification of passively temperature-controlled packaging systems is based on the determination of temperature distribution and the testing and measurement of load limits.

Metrological testing and documentation:

  • Temperature distribution studies for the packaging system
  • Determination of section profiles
  • Implementation of winter and summer mappings
  • Testing and determination of load limits
  • Determination of suitable packaging system
  • Carrying out of risk analyses and conception of risk management in accordance with ICQ Q 9

 

Qualification of packaging systems by Testo Industrial Services

As a qualification service provider, Testo Industrial Services will support you in all of your quality assurance measures in the field of qualification. We will qualify your actively air-conditioned transport systems:

  • Vehicles, containers and trailers for road transport
  • Integral container or porthole container for air and sea transport
  • Single-chamber and multi-chamber systems
     

Metrological testing and documentation:
 

  • Climatic mapping and temperature distribution studies
  • Winter and summer mappings
  • Challenge tests/stress tests to check load limits
  • Inclusion and testing of section profiles
  • Carrying out of risk analyses and conception of risk management
  • Evaluation of the routine monitoring positions and “critical points”
  • Conception and performance of standard qualifications (“design qualification”)
Qualification of transport systems by Testo Industrial Services

More service, more security for your GMP compliance

What sets us apart

Expertise

Consulting, measurements, project management – our team with experience of the industry will support you precisely according to your needs

Technology

The use of our extensive test and measuring equipment with more than 4,500 references ensures reliable measurement and test results

Documentation

We will hand over the documentation to you in person upon completion of the order in audit-proven layout or customised to requirements

Transportation and storage qualification

Our references

Transportation and storage qualification

Further information

Your contact

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