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Bosch Packaging Technology will introduce its newest R&D device for continuous oral solid dosage production at Achema 2018.
Bosch Packaging Technology will introduce its latest R&D device for the continuous production of oral solid dosage (OSD) forms at Achema 2018. The platform ensures a short time to market and optimum dosing of active pharmaceutical ingredients (APIs), according to the company.
“The new laboratory device is based on our Xelum production platform that we presented last year,” said Fritz-Martin Scholz, product manager at the Bosch subsidiary Hüttlin, in a company press release. “The separated process steps of batch production take place one after the other and without interruption. This leads to shorter cycle times, lower production costs, and high flexibility.”
The Xelum R&D technology offers a platform to initiate continuous manufacturing.
In the Xelum R&D device, excipients and active ingredients are dosed as a discrete mass, compared to the common complex mass flow rate. This makes it possible to dose even the smallest amounts of APIs of less than 1%. The system doses, mixes, and granulates individual packages, called X-keys, which continuously run through the process chain and are removed successively from the machine as packages into bins. Depending on requirements, up to four loss-in-weight feeders can be used.
“This way we reduce not only process complexity, but also the system’s failure susceptibility, while increasing both accuracy and quality of the end product. Moreover, the product is traceable at all times,” said Scholz in the press release.
The Xelum R&D device uses the same components for dosing, mixing, and granulating as the Xelum production platform from Bosch. As a result, process parameters are identical and can be directly transferred 1:1. “Scale-up becomes obsolete, which reduces development time and API usage, since elaborate tests are no longer necessary,” Scholz explained.
In addition, material flow from dosing to emptying takes place in a closed process (bin-to-bin) to optimize safety.
Current continuous production systems for wet granulation mostly use twin screw granulators. In comparison, the Xelum R&D system relies on fluid bed processors, which is based on technology developed by the Bosch subsidiary Hüttlin. In the fluid bed, granulation and drying take place in the same process chamber. “This eliminates the need to transfer wet granules, which in turn has a positive effect on the system’s reliability,” Scholz explained in the release.
Pharmaceutical manufacturers obtain granulates with the desired characteristics, including unimodal particle size distribution as well as flow and tableting properties combined with high production yields.
The controls of the Xelum R&D correspond to a modern production system. All relevant process parameters are continuously recorded. Both production and product transfer, as well as the cleaning process, are recipe-controlled and ensure reproducible results. The user-friendly handling of the system is complemented by design-of-experiment software support.
Achema 2018 runs from June 11–15 in Frankfurt, Germany.
Source: Bosch Packaging Technology, Hall 3.1, Booth C71