Understanding the thermal behaviour of your product and identifying key parameters is vital for process design and optimisation. Our consultancy services enable the identification of the optimal parameters for freeze drying your product. It will enable you to evaluate existing risks and design a roadmap for process optimisation.
Having this data to hand early on in process development can save valuable time and money by reducing the amount of trial-and-error required. Where an existing cycle is already in use, this information provides evidence of the suitability of the process and reveals where there is scope to increase safety or improve efficiency. The information provided is also invaluable for those who are preparing a regulatory submission as it will justify your freeze drying process with quantifiable evidence of its suitability.
Our scientists will undertake a range of detailed analyses to characterise your freeze dried product, including Freeze Drying Microscopy, DTA & Impedance Analysis, DSC, and Moisture Analysis. This information is then investigated in relation to your lyophilisation cycle and equipment specifications. A full report is provided which includes complete appendices, key data highlights and an explanation of our findings in the context of your specific product. Our specialists will also provide advice on the application of this information to your process, drawing on our extensive experience of freeze drying a vast range of products to guide you toward process optimisation.
You will benefit from our troubleshooting and expert consultancy services if you are:-
· Currently preparing a regulatory submission: BTL will provide the supporting data to justify your chosen process
· Seeking to optimise an existing process: BTL will reveal where there is scope to shorten your cycle time and increase the efficiency of your process
· Encountering difficulties in development: BTL will give you the insights to produce freeze dried product that meets your ideal performance specification
This service early in the process development phase can save valuable time and ensure that your project plan remains on track.