NEW BUILD VACCINE FACILITY QUALIFICATION

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As part of a new build facility for Medimmune for the production of FluMist, an Influenza vaccine, Valcomm was appointed by the principal contractors to provide qualification support, thermal mapping and calibration for the facility.

The qualification effort spanned extremes of temperature from -196°C cryogenic storage chambers to environmental chambers and egg incubators.

Areas Valcomm assisted with included:

  • Consultants in the preparation of qualification documents and advising the client on their content.
  • The supply of rental thermal mapping equipment (Kaye 2000 validator with associated elements and Rotronic HydroLog data loggers) for pre-qualification exploratory analysis.
  • Optimisation of control characteristics for the storage areas and equipment based on the captured data from the pre-qualification exercises.
  • Performance of thermal mapping studies to the client prepared protocols for storage areas and processing equipment.
  • Formal qualification of the wholesale pharmacies and refrigerated storage areas storage areas.

Due to the significant number of thermal mapping projects required, Valcomm set up a temporary calibration workshop environment with precision calibration baths, hot blocks and standard references.

This enabled greater accuracy for pre and post calibration of sensors for each mapping campaign and provided assurance of results. All mapping campaigns were analysed and documented within the client pre-approved protocols.


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