Bosch Packaging Technology presents its newly developed freeze dryer. The lyophilization system can be used to stabilize thermolabile [subject to alteration or destruction by heat] and delicate active ingredients such as oncological medications, vaccines or antibodies.
The system, developed at the company’s Austrian subsidiary Schoeller-Bleckmann Medizintechnik (SBM), rounds out Bosch’s portfolio for pharmaceutical liquids. Short time-to-market, high quality and cost efficiency are key for pharmaceutical manufacturers. The freeze dryer is energy efficient an offers short cycle times together with reliable product quality in large batches.
Its modular design makes the GMP-compliant freeze dryer suitable for the production of small batches for clinical trials, as well as for medium and large production batches.
During the freeze-drying process, water is extracted from the drugs by means of sublimation without affecting its properties. Depending on the individual product, the shelf life can be extended many times over. The dry, porous lyo cake can be quickly and easily reconstituted shortly before use by adding sterile water.
During the development of the system, the company attached particular importance to optimum space design to make processing and cleaning times as effective as possible. At the same time, energy efficiency was also a high priority. As a result, the shelves were produced using laser welding technology, which ensures a 100% controlled, automated and reproducible manufacturing process. This is essential for consistent and reliable product quality. Moreover, by using thinner sheets, the weight of the shelves has been reduced compared to alternative production processes. Thanks to this weight reduction, less mass has to be cooled and heated, which has a positive effect on energy consumption.
Another advantage of the system is the homogenous temperature distribution in the shelves. The internal channeling and flow velocity were optimized on the especially developed test bed to ensure consistent heat exchange. This means that all containers in the freeze dryer are exposed to the same temperature. This offers customers optimal cycles with consistent product quality. The tilting shelves ensure rapid cleaning as the slight tilt enables water droplets to quickly drain from the surface, shortening the cleaning and drying time. The tilt angle also improves the performance of the CIP nozzles, reducing water consumption.
The new freeze dryer is designed so that customers can use different container sizes and formats. The distance between the shelves can be varied due to patented Double Shelf Interdistance technology. That permits switching between single or double shelf spacing to avoid wasting space. This means that the space in the freeze dryer is always optimally used, whether tall or small vessels are employed.
To respond quickly to customers’ individual layout requirements, the various components, such as the vacuum unit and the cooling system, have been divided into modules. Due to the modular system, the freeze dryer can be adapted to fit the available space and customer requirements.
The freeze dryer was developed based on the user-experience approach, taking know-how gained from customer projects and discussions with equipment producers and pharmaceutical manufacturers into account.
The matching interfaces ensure rapid and seamless connection to the upstream filling machine with isolator technology, the downstream capping machine, inspection system and secondary packaging station. Customers benefit from smooth processes with significantly reduced risk of downtimes. Standardized control and documentation, as well as rapid validation, shortens time-to-market.
Bosch’s offer is rounded off by the global service network, which offers customers quick support with maintenance and process optimization all over the world.