Cleanrooms
We can perform the Validation of Cleanrooms to meet requirements of ISO14644, ISO14698 and cGMP guidelines (Annex 1:Mar 09).
Selection of services offered :
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1.Particle Counts
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2.Air Change Rates
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3.Differential Pressure Checks
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4.Particulate Cleanup Rate Checks
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5.Air Flow Pattern Testing (Smoke Visualisation)
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6.Microbiology Sampling – Air Samples/Contact Plates/Settle Plates
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7.HEPA/ULPA Filter Integrity Testing
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8.Room Temperature and Relative Humidity Mapping
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9.Lighting Level Verifications
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10.Sound Level Verifications
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11.Containment Leak Testing
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12.VMP/DQ/IQ/OQ/PQ/Re-OQ
Experienced with the following:
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1.Classification of rooms to meet industry regulations
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2.Complete Validation Process from URS through to PQ
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3.Specialise in cGMP documentation packages