Autoclaves
We can perform the Validation of Autoclaves to meet requirements of EN285, CFPP01, HTM01-05 and cGMP guidelines – we are sub-contracted by 2 major Autoclave manufacturers to carry out these studies on their behalf!
Our engineers are City & Guild Certified and GMP trained.
Selection of services offered :
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1.Steam Quality Testing
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2.Air Detector Testing (including setting them up)
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3.Leak Rate Testing
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4.Bowie Dick
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5.CFPP01/EN285 Thermometric Testing
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6.GMP Type Mapping (tubing/filters/stoppers etc) including full Biological Indicator Testing
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7.Chamber Wall Mapping
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8.Liquid Mapping (f0)
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9.IQ/OQ/PQ/Re-PQ
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10.FAT Testing
Experienced with the following:
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1.Priorclave
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2.Boxer
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3.Astell
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4.Little Sister
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5.Steris
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6.SAL
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7.BMM
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8.Getinge
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9.Telstar/Celester