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.
Selection of services offered :
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1.GMP Type Mapping (vials/glassware etc) including full Biological Indicator Testing and Endotoxin Testing
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2.HEPA Filter Testing
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3.Air Flow Testing
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4.HTM 2010/EN285 Thermometric Testing
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5.Chamber Mapping to Ascertain Hot/Cold Spots
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6.Cycle Development to ensure load is ready for full PQ testing
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7.IQ/OQ/PQ/Re-PQ
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8.FAT Testing
Experienced with the following:
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1.MMM
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2.Telstar/Celester
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3.Binder
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4.Handling and Recovering BI’s and Spiked Endotoxin Vials
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5.Lytzen
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6.Hereaus