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Vials on shelf (1)Process Scale-Up and Optimisation

Freeze drying cycles are optimised with respect to specific product, formulation, batch and equipment parameters. A change in any of these may affect the behaviour of the product during the cycle.

Scaling Up

Changing batch size, container size, fill depth or even simply equipment can affect processing. It is especially important to note that large-scale production dryers may have different capacities to smaller R&D systems in terms of temperature, condenser load and process energy. A cycle that is optimised for the lab may not be suitable – or even possible – on larger systems.

Why Optimise?

• Overlong or overcautious cycle parameters add unnecessary costs to energy bills and significantly reduce batch turnaround.
• Cycles that are too short or too aggressive risk compromised product stability and even outright product failure.
• Cycles that are unsuitable for the equipment may cause production delays as the equipment halts or alarms, requiring operator intervention.
• Processing defects can be invisible to the naked eye with the subsequent issues only arising during quality control or testing.

How it Works

Closeup_Olympus_lens_BioGroupAnalyses of your product with our freeze drying instruments Lyostat and Lyotherm provide key data about the essential characteristics of the product. This is analysed against the existing cycle to ensure it is suitable and optimised. A small amount of product is processed using our pilot-scale freeze dryers, which are equipped with sophisticated monitoring and data trending capabilities to return information about the progression of the product throughout the process. The dried product is then tested to ensure the required moisture content (dryness) has been achieved. Finally, the demands of the cycle are compared with the specific capabilities of the equipment to be used.

A full report is supplied detailing the tests carried out, the results, and any suggested alterations.

 

The Benefits of Biopharma’s Approach:

• In-depth product and process data invaluable for quality control or regulatory requirements
• A cycle that is optimised for your specific requirements – efficient and robust
Dedicated standalone facility for cytotoxic products

 

For more information, please contact us here, +44 (0)1962 841092 or:

 

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