GEA plants, processes, components, and services enhance the efficiency and sustainability of production processes across the globe.

With more than 18,000 employees working across five divisions and 62 countries, the group generated revenues of more than EUR 5.1 billion in fiscal year 2022. The international technology group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components, and comprehensive services. GEA is one of the world's largest suppliers of systems and components to the food, beverage, and pharmaceutical industries. Furthermore, LYOSPARK® offers better scalability and higher throughput speeds than conventional systems, resulting in optimized performance and productivity. Inside the supercooled product solution, the ice crystals undergo immediate and homogenous nucleation in each vial.Īs the formation of ice crystals at higher temperatures results in larger pores, drying times can be shortened. Ice crystals form on the cooled surface of the trap and are entrained in the gas stream during venting. As soon as the nucleation temperature is reached, the chamber is vented with gas from the freeze dryer’s condenser.Ī filter-equipped cooling trap is mounted on the chamber. The vials are loaded into the freeze dryer as usual and cooled to the optimal (product dependent) nucleation/cooling temperature. LYOSPARK® enables the user to control the temperature at which nucleation crystals form inside the product, thereby ensuring that, at any time, every vial in the chamber is subjected to the same process conditions, irrespective of its specific location on the shelf.Ĭombining LYOSPARK® technology with conventional freeze-drying processes is very simple. For a typical pharmaceutical formulation filled in vials, for example, crystals might form at temperatures ranging from –5 to –20 ☌).Īs the nucleation temperature has a direct impact on the developing ice structure and crystal size - as well as the appearance of the dried product cake - it can negatively influence the product’s Critical Quality Attributes (CQAs), such as residual moisture or dissolution behavior.Ī patented and proven technology from GEA, which is fully compatible with all our currently available freeze dryers, provides a novel and scalable method to control the nucleation process without having to develop new pharmaceutical formulations. Historically, because of the random nature of the nucleation process, lyophilization has been difficult to control. As such, forcing ice crystals to nucleate at a specific temperature, rate and time can improve the homogeneity of the batch and reduce the cycle duration. The nucleation of ice crystals (the initial stage of ice formation during freezing) is a naturally spontaneous and protracted process. The lyophilization process comprises three main stages: freezing (solidification), primary drying (ice sublimation) and secondary drying (moisture desorption). Given the absolute requirements to minimize contamination, eliminate operator exposure and protect the product, further containment options include isolators, conventional cleanrooms or both active and passive Restricted Access Barrier Systems (RABS).Ī novel approach to simple, reliable and easily controlled nucleation during industrial freeze drying We were also the first company to provide an isolated ALUS in the 1990s. Invented by GEA in 1980s, ALUS ® minimize the risk of operator/product contamination while loading and unloading a freeze dryer, offering shorter processing times, improved productivity and reduced operational costs.

Depending on the complexity of the installation and based on previously completed projects, it is possible to have a system up and running in less than a year. LYOVAC ® is also available using GEA’s unique Fast Track manufacturing process. In addition, all LYOVAC ® freeze dryers can be integrated with our Automatic Loading and Unloading System (ALUS ®). No matter what the size or the arrangement, the unique shelf design ensures high drying rates and uniform results. In a single-floor setup, the orientation of the condenser can be on the side or behind the drying chamber.

LYOVAC ® freeze dryers can be arranged on one or multiple floors, such that the condenser is typically situated under the drying chamber and ensures both easy access to the machine parts and complete separation between the cleanroom and the technical area.

Lyophilizer freeze dryer