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Even when using the largest machines, the unique shelf design ensures high drying rates and uniform results. The freeze dryers can be arranged on one or multiple floors, where the condenser is typically situated under the drying chamber, which enables complete access to all the machine parts without interfering with the cleanroom. In a single-floor setup, the orientation of the condenser can be on the side or the rear of the drying chamber. Irrespective of the arrangement, the LYOVAC™ design ensures the same drying performance and uniform results.
Based on standard components, GEA supplies plant for cGMP production that is configured to meet the customer’s specific requirements. In addition, all LYOVAC™ freeze dryers can be integrated with the company’s automatic loading and unloading system (ALUS™).
What’s more, LYOVAC™ is available using GEA’s unique Fast Track manufacturing process that could have the system up and running in your pharmaceutical processing line in less than nine months.
A single LYOVAC™ Freeze Dryer or multiple units can be supplied with or integrated with GEA’s Automatic Loading and Unloading System (ALUS™). Further, containment options include isolators, conventional clean rooms or both active and passive Restricted Access Barrier Systems (RABS). For many customers, it is vital to minimize contamination risks, eliminate operator exposure and protect the product. In these situations, a production system incorporating a freeze dryer, ALUS™ and isolators is recommended.
ControLyo™ on-demand nucleation technology, licensed from Praxair, delivers improved product uniformity, quality and yield, while reducing freeze drying cycle times by up to 40%.
This proprietary technology can control the nucleation temperature of a solution to within 1 ºC of its freezing point, providing exceptional control and vial-to-vial uniformity. Historically, owing to the random nature of nucleation in the freeze dryer, lyophilization has been difficult to control. Vial contents for a typical pharmaceutical formulation would nucleate across a broad range of temperatures (5–20 °C below the freezing point) and, as nucleation temperature directly affects ice structure formation and crystal size, as well as cake structure and appearance, it can adversely influence final product CQAs (Critical Quality Attributes) such as product humidity or dissolution behaviour. Now, a patent pending process technology, implemented on GEA freeze dryers, offers a novel and scalable method to control nucleation without having to reformulate the drug.
This state-of-the-art nucleation control technology allows users to select the temperature at which the product is nucleated. ControLyo™ then ensures that every vial in the freeze dryer chamber, regardless of location, experiences the same process conditions at exactly the same time, resulting in simultaneous nucleation. Implementing the ControLyo™ process step in a conventional freeze drying cycle is very straightforward. The vials are loaded into the freeze dryer and cooled to a target nucleation temperature. During the cooling step, the chamber is pressurized with an inert gas and, once the desired nucleation temperature is reached, the chamber is rapidly depressurized, which triggers the sub-cooled solutions in the vials to nucleate and begin freezing instantaneously and homogeneously. ControLyo™ offers a higher initial pressure and a faster pressure drop than conventional systems, resulting in optimized performance and productivity.
Eradicating issues such as API damage from ice crystals and unpredictable scale-up, ControLyo™ offers a number of technical benefits, including improved product quality, better vial-to-vial uniformity, a more homogenous — and aesthetically pleasing — cake and reduced protein aggregation. In addition, the process complies with the US FDA’s QbD initiative. Also, as nucleating at warmer temperatures produces larger ice pores in the freeze-dried material, drying times can be shortened significantly. Further benefits include improved process control (more uniform product temperature paths), better reconstitution, reduced risk of vial cracking and less freezing stress on biologicals.
The cost-effective technology, in terms of both operating and capital expenditure, is offered as an option with all new GEA freeze dryers and can also be retrofitted to existing pressure-rated machines.