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.
The lyophilization process comprises three main stages: freezing (solidification), primary drying (ice sublimation) and secondary drying (moisture desorption). The nucleation of ice crystals (the initial stage of ice formation during freezing) is a naturally spontaneous and protracted process. 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.
Historically, because of the random nature of the nucleation process, lyophilization has been difficult to control. For a typical pharmaceutical formulation filled in vials, for example, crystals might at temperatures ranging from –5 to –20 °C).
As 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.
A new patent-pending 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.
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 its specific location on the shelf.
Combining LYOSPARK® technology with conventional freeze-drying processes is very simple. The vials are loaded into the freeze dryer as usual and cooled to the optimal (product dependent) nucleation temperature. As soon as the nucleation temperature is reached, the chamber is vented with gas from a condenser.
A filter-equipped cooling trap is mounted on the chamber. Ice crystals form on the cooled surface of the trap and are entrained in the gas stream during venting. Inside the supercooled product solution, the ice crystals undergo immediate and homogenous nucleation in each vial.
As the formation of ice crystals at higher temperatures results in larger pores, drying times can be shortened. Furthermore, LYOSPARK® offers better scalability, sterility and higher throughput speeds than conventional systems, resulting in optimized performance and productivity.
LYOSPARK®, which eliminates issues such as the denaturation of active ingredients or unpredictable scale-up, also provides a number of technical advantages, including improved product quality, better vial uniformity per batch and a more homogenous, aesthetically pleasing cake.
In summary, LYOSPARK® controlled nucleation technology facilitates uniform ice crystal formation in laboratory and production-scale freeze dryers with a minimum degree of supercooling. This is reflected in more consistent and larger ice crystal sizes with a more open product structure. As a result, faster drying and reconstitution times can be achieved.
QbD-compliant, GEA’s LYOSPARK® delivers a more uniform, higher quality product, reduces process times and provides a cost-effective solution to controlled nucleation.
At a glance advantages
This cost-efficient technology will be offered as an option for all GEA freeze dryers and will also be available as a retrofit option for existing plant.