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The Complexity and Beauty of Lyophilization

The lyophilization process primarily consists of three stages. The first stage is freezing, which involves freezing the product and creating a solid matrix suitable for drying. This step impacts the drying characteristics of the next two stages. The second stage is primary drying, sometimes preceded by an additional step called annealing or thermal cycling. Primary drying involves the removal of ice through sublimation by reducing the pressure of the product environment while maintaining the product temperature at a low target level. The third stage in the process is called secondary drying, in which bound water is removed until the residual moisture content reaches its targeted level.

Common problems with lyophilized drugs in the lyophilization process

COLLAPSE Cause: It is a phenomenon which occurs in amorphous solids when the product reaches a higher temperature than the collapse temperature, Tc (closer to the glass transition temperature Tg’). The amorphous phase of the solid experiences internal movement without reaching the melting point, with the crumbling or collapse of the dried cake as a result. Solution: Maintain the product temperature below the collapse temperature during all the primary drying time (while there is still presence of ice in the product). Avoid the formation of a “dried skin” at the top of the surface. MELTBACK: Cause: It happens when the primary drying phase has ended but some of the vials still have some ice at

Freeze-Drying Food

Freeze-drying is a very gentle dehydration process used for preservation of high quality foods. During the 1950s, industrial freeze-drying of foods began. Coffee was one of the first freeze dried food products to be produced, but now vegetables, fruits, meats, fish, dairy products, herbs and food flavourings can be successfully freeze dried. The Incas even used a crude form of freeze-drying by leaving potatoes to freeze overnight and then stomping out the ice crystals in the morning. The final freeze-dried food typically contains between 1% and 4% moisture. Final food products are nitrogen sealed and packed. They can be stored between 6 months and 3 years in polybags and 25 years or longer i

Upscaling with Teclen Lyoprotect® containers

The transfer of the recipe from laboratory scale to production scale is one of the biggest obstacles for manufacturers. Freeze drying is a technology that entails a high energy consumption. A poorly optimized recipe can cause the economic cost of making the lyophilized product to explode, in addition to negatively affecting productivity. A new interesting way to reduce the risk of product loss is by adapting to Teclen Lyoprotect® containers. Benefits of Teclen Lyoprotect® containers: Volumes can be seamlessly scaled up. The same parameters determined in process development can be used with the different containers, if same filling height is maintained. Consistent concept: container with memb

Using new chemicals in your freeze dryer?

Freeze driers are designed to be chemical resistant to most compounds that are commonly used in freezedrying processes. However, a freeze dryer is comprised of a number of different materials, some of which may be attacked and degraded by certain chemicals. The degree of degradation is dependent on the concentration and exposure duration. Check this table whenever you have doubts about using new chemicals in your freeze dryer.

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