Qualification and Validation

Qualification and Validation process are essential parts of the healthcare’s quality assurance system. It must demonstrate that the site, equipment and packaging are suitable for the intended use, and also should guarantee that the quality and integrity of the product is maintained.

Qualification and Validation processes are used to ensure:

    • The site – Warehouse and Temperature-Controlled areas
    • The equipment – Refrigerated Systems, Trucks and Vehicles
      We use state of the art technology and a comprehensive range of unique tools – including WHO-UNICEF qualified temperature recorders, to collect data without breaking seals on packaging containers, trucks or trailers
    • The systems – Temperature Monitoring Equipment
    • The packaging – Temperature-Controlled Shippers

Operational Qualification and testing in qualified environmental chambers is an economical method of determining the suitability and performance of a shipper.
Cold Chain Consultants specialise in environmental testing and mapping of temperature controlled shippers, pallets and components to assist customers to determine the packaging’s suitability to maintain product’s temperature during transport

  • The processes as installed or modified are operating according to the specifications and comply with regulation

 

CCC Qualification and Validation Services:

  • Supply Chain Temperature Mapping

     

     

  • Warehouse, Cool Rooms, Fridges and Freezers DQ, IQ, OQ, Thermal Mapping and PQ.

  • Refrigerated vehicles, trucks and containers DQ, IQ, OQ, Thermal Mapping and PQ.

  • End-to-end temperature sensitive supply route mapping services to collect temperature data and prepare reports and recommendations.

  • Independently cold chain packaging assessment, Design, Operational and Performance qualification and testing.

    Under controlled conditions the packaging can be tested to conditions normally experienced during the coldest winter and hottest summer days.

    Testing profiles where packaging is transported between hemispheres can be replicated to determine whether product temperature is maintained.

    Chamber Testing is available from -20°C to +60°C