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Select service which you require

Depyrogenation Ovens

We can perform the Validation of Depyrogenation Ovens to meet requirements of EN285, HTM2010 and cGMP guidelines – we are sub-contracted by 2 major Oven manufacturers to carry out these studies on their behalf!

Our engineers are City & Guild Certified and GMP trained.

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Selection of services offered :

  • 1.
    GMP Type Mapping (vials/glassware etc) including full Biological Indicator Testing and Endotoxin Testing
  • 2.
    HEPA Filter Testing
  • 3.
    Air Flow Testing
  • 4.
    HTM 2010/EN285 Thermometric Testing
  • 5.
    Chamber Mapping to Ascertain Hot/Cold Spots
  • 6.
    Cycle Development to ensure load is ready for full PQ testing
  • 7.
    IQ/OQ/PQ/Re-PQ
  • 8.
    FAT Testing

Experienced with the following:

  • 1.
    MMM
  • 2.
    Telstar/Celester
  • 3.
    Binder
  • 4.
    Handling and Recovering BI’s and Spiked Endotoxin Vials
  • 5.
    Lytzen
  • 6.
    Hereaus

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Biocity Scotland
Bo'Ness Road, Newhouse
ML1 5U

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