Product characterization is the foundation for all formulation and process development. LyophilizationWorld uses a range of specific analyses to understand the behaviour of your product throughout the freeze drying process, and the impact of the different components in it.
The determination of the design space provides some flexibility in the development of the recipes and facilitates the scaling between the lyophilization process in laboratory equipment to production equipment on an industrial scale.
The first step for the development of a recipe is the characterization of the product to determine its properties. The analysis of the information obtained, combined with an in-depth knowledge of the process and the equipment, gives our Lab the ability to design an optimal lyophilization recipe from scratch or optimize an existing recipe, saving time and money in the production of each batch.
We study your product using techniques such as differential scanning calorimetry, known as DSC (Differential Scanning Calorimetry), to determine the type of product (crystalline or amorphous) and its critical temperature, eutectic in the case of a product crystalline and collapse if the product is amorphous as well as the lyophilization microscopy (FDM) used to determine the collapse temperature of the product (Tc)
At our Lab we perform Moisture Analysis by Karl Fisher and establish the amount of moisture remaining in your product after processing (generally working on 3-5% residual moisture). Moisture analysis is carried out across a batch or several batches to verify that the process is robust enough to tolerate the inevitable variation both within and between batches. This analysis also demonstrates the success and efficiency of the freeze drying process overall.
Modulated Differential Scanning Calorimetry (mDSC) analysis enables glass transitions and other significant events such as crystaliziations to be identified within the freeze dried product. This is necessary to verify that the dried product will retain its structure in storage, resulting in good long-term stability.