Frankfurt/Main, Germany – At Achema 2015, Bosch Packaging Technology showcases three process technology novelties for the production of liquid pharmaceuticals. Visitors can see a new bioreactor for the cultivation of active pharmaceutical ingredients (APIs) on laboratory and pilot scale. Bosch further showcases an energy-efficient and compact distillation unit for the production of WFI (Water for Injection). It combines two different processes in one platform for the first time and enables the direct production of WFI from drinking water. Moreover, Bosch introduces the new generation of pure steam generators. “The units fit in perfectly with the exemplary lines for the processing of sterile liquid pharmaceuticals shown at Achema, and emphasize Bosch’s line competence,” explains Dr John Medina, sales director at the Bosch subsidiary Pharmatec, which has developed all three novelties.
Bioreactor for research and pilot batches
“Whether customers produce oncology drugs, insulin preparations or medicines for the treatment of autoimmune diseases – our bioprocessing units for the pharmaceutical industry enable the production of high-quality biopharmaceuticals with excellent process results,” says Medina. For the first time, Bosch now offers a complete machinery range covering different scales for laboratories, clinical studies, and production.
The fully automated bioreactor for batch sizes between 15 and 50 liters is delivered with the complete periphery required for bioprocesses. This way Bosch complements the existing portfolio of fermentation devices, which to date are available for production volumes of 500 to 5,000 liters. Moreover, Bosch offers complete solutions for the subsequent downstream processes, as well as for the final formulation of the injection solution. “In accordance with our line competence, we can also integrate further downstream modules from specialized manufacturers upon demand. This allows customers to accomplish their entire project with only one point of contact,” Medina emphasizes. The complete solutions can also be easily combined with further filling and packaging machines for liquid pharmaceuticals from Bosch.
High purity media of the highest quality
In all pharmaceutical and biopharmaceutical manufacturing operations, product quality and patient safety come first. This is also true for high purity media, such as WFI. At Achema, Bosch showcases a new unit, which uses a patented vacuum membrane distillation technology. This highly efficient thermal process combines both distillation and membrane filtration in one modular concept. “Hence we fulfill the current and future requirements of the European, U.S. and other international pharmacopeia for the production of WFI,” says Medina.
Due to the especially effective membrane distillation, the unit can prepare WFI immediately from potable water without intermediate steps. Compared to conventional distillation units, the relatively low temperatures of 50 to 80 degrees Celsius achieve high energy savings while ensuring effective protection against germs and contamination. In a first step, ordinary potable water is evaporated, before it is pressed through a plastic membrane for filtration and then condensed. The membrane system withholds suspended solids, dissolved organic material and bacteria. Online measurements of TOC (total organic carbon), pressure, temperature and conductivity monitor the process continuously. To ensure pharmaceutical water quality regarding microbiological purity, the unit can be additionally sanitized at 85 degrees Celsius.
Complete solutions from a single source
Bosch furthermore presents the new generation of energy-efficient pure steam generators and distillation units. The optimized thermal utilization of heating energy enables high WFI and pure steam yields, which result in reduced operating costs. “We have streamlined our number of pure steam generators and types of distillation units and have put them together in a consistent range to reduce delivery times, as well as investment costs. The series now encompasses a performance range of 100 to 7,500 kilograms per hour,” Medina explains.
Depending on requirements and application areas, these three new developments offer customers complete solutions for water preparation, as well as product development and production from a single source. From the first stage of drug development, Bosch supports pharmaceutical and biopharmaceutical manufacturers with the appropriate technologies as well as profound consulting and services.
Bosch’s technologies are on display at Achema in Frankfurt/Main, Germany, from June 15 to 19, hall 3.1, booth C71.