0845 0034247
 

Select service which you require

Select service which you require

Cleanrooms

We can perform the Validation of Cleanrooms to meet requirements of ISO14644, ISO14698 and cGMP guidelines (Annex 1:Mar 09).

 

clening-room

 

Selection of services offered :

  • 1.
    Particle Counts
  • 2.
    Air Change Rates
  • 3.
    Differential Pressure Checks
  • 4.
    Particulate Cleanup Rate Checks
  • 5.
    Air Flow Pattern Testing (Smoke Visualisation)
  • 6.
    Microbiology Sampling – Air Samples/Contact Plates/Settle Plates
  • 7.
    HEPA/ULPA Filter Integrity Testing
  • 8.
    Room Temperature and Relative Humidity Mapping
  • 9.
    Lighting Level Verifications
  • 10.
    Sound Level Verifications
  • 11.
    Containment Leak Testing
  • 12.
    VMP/DQ/IQ/OQ/PQ/Re-OQ

Experienced with the following:

  • 1.
    Classification of rooms to meet industry regulations
  • 2.
    Complete Validation Process from URS through to PQ
  • 3.
    Specialise in cGMP documentation packages

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Biocity Scotland
Bo'Ness Road, Newhouse
ML1 5U

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