Freeze Driers
We can perform the Validation of Freeze Driers to meet requirements of HTM2010 (sterilisation) and cGMP guidelines – we are sub-contracted by a major 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.Leak Rate Testing
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2.Steam Quality Testing
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3.System Calibration
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4.HTM 2010/EN285 Thermometric Testing
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5.Biological Indicator Studies for Sterilisation Cycles
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6.IQ/OQ/PQ/Re-PQ
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7.Shelf Mapping/Profiling
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8.Liquid Mapping
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9.FAT Testing
Experienced with the following:
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1.Celester
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2.Telstar
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3.FTS
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4.Christ
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5.Handling, distributing and incubation of Biological Indicators (Bacillus Stearothermophilis)