The pharmaceutical lyophilization system can be used to stabilize thermolabile and delicate active ingredients, like oncological medications, vaccines or antibodies. The system, which was 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. Our new freeze dryer is not only energy efficient, but also offers short cycle times together with reliable product quality in large batches,” explains Annabel Madero, product manager at SBM. Its modular design makes the GMP-compliant freeze dryer suitable for the production of small batches for clinical trials, as well as for medium production batches.
Reliable stabilization of pharmaceuticals
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. “Compared to powder filling, liquid filling is significantly more precise, and achieves more exact dosing,” Madero says.
Optimum shelf design
“During the development of the system, we 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,” Madero explains. As a result, the shelves were produced using laser welding technology, which ensures a 100 percent controlled, automated and reproducible manufacturing process. This in turn is essential for consistent and reliable product quality. Moreover, by using thinner sheets, the weight of the shelves has been significantly 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. “With such large temperature differences, every gram counts,” Madero says.
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,” says Madero. The tilting shelves ensure rapid cleaning: 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. Thanks to our patented Double Shelf Interdistance technology, customers are able to switch 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,” Madero adds.
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 robust system meets Bosch’s high quality and safety standards and fits seamlessly into the company’s comprehensive pharma portfolio. 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,” Madero says. “What’s more, 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.