Freeze Dryer Offers Flexible Output Rates

Description

A newly developed freeze dryer features a modular design that makes the GMP-compliant freeze dryer suitable to produce small batches for clinical trials, as well as for medium and large production batches. The lyophilization system can be used to stabilize thermolabile and delicate active ingredients, like oncological medications, vaccines or antibodies.

 

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.

 

The shelves were produced using laser welding technology, which ensures a 100% 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.

 

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. 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 freeze dryer is designed so that customers can use different container sizes and formats. 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.

 

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.

Specs

Features:

  • Optimal shelf design ensures uniform temperatures and rapid cleaning due to a patented tilting shelf mechanism
  • Variable container size thanks to double shelf interdistance
  • Harmonized interfaces for upstream and downstream line components provide efficient processes
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