An appropriate cycle development will enable the customer to minimise the freeze drying cycle time and therefore maximise the productivity of a plant.
Moreover, the development of a freeze drying cycle at laboratory scale and an appropriate scale-up programme to industrial equipment size will enable the customer to meet the objectives of fast track projects. Performing cycle development activity in parallel with the installation and commissioning of the new facility will help to significantly reduce the time of start-up to production.
IMA LIFE Freeze drying solutions laboratory facilities can offer a complete set of equipment for the cycle development study, including:
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Freeze dryers |
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Filling machine (manual) |
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Karl Fischer analyser to verify the residual moisture after lyophilisation |
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Differential Scanning Calorimetry (DSC) analyser to verify the eutectic point and phase transitions |
IMA LIFE Freeze drying solutions personnel will support the customer up to the production qualification and start-up at industrial scale. The freeze drying cycle development will focus on:
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Optimising the freezing temperature and cooling time |
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Vacuum to optimise the heat transfer from shelves to product avoiding undesirable melting |
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Product temperature to optimise the primary and secondary drying time modifying the shelf temperature and vacuum with calibrated leak (nitrogen gas bleeding) |
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The secondary drying phase using calibrated leak and shelf temperature to reduce time and meet the customer request for residual moisture |
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Measurement of the residual moisture |
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Karl Fischer analyser to verify the residual moisture after lyophilisation |
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DSC analyser to verify the eutectic point and phase transitions |
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Solid Dose Processing / Manufacturing
Aseptic Processing & Freeze Drying
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