Freeze drying process development.
Freeze drying is a key technology for the regulated GMP sector.
Freeze Dry Solutions was born to give an answer to the specific needs of customers.
The design space is a concept of Quality by Design (QbD), which consists in the delimitation of the range of each parameter of the process within which it is ensured that the product obtained has the required quality attributes.
The determination of the design space provides some flexibility in the development of the recipes and facilities the scaling between the lyophilization process in laboratory equipment to production equipment on an industrial scale.
Freeze drying is a technology that entails high energy consumption. A poorly optimized recipe can cause the economic cost of making the lyophilized product to increase, in addition to negatively affecting productivity.
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 COMSER 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.
The conception of the formulation and the selection of suitable excipients is a transcendental phase in the development of any lyophilized product for its large-scale manufacture. A good formulation allows a greater stability of the API and provides protection against the stress suffered during the same lyophilization process.
This is the study of the 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).
The transfer of the recipe from laboratory scale to production scale is one of the biggest obstacles for manufacturers. COMSER Lyo offers its experience and knowledge to minimize the problems arising during this transition, as well as tools that facilitate scaling.
COMSER Freeze dry Solutions
The exclusive distributor in Spain of the TEMPRIS wireless sensors for real-time temperature measurement as well as the best lyophilization equipment of the prestigious brand SP Scientific.