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Container Requirements Profile
Modular design is based on the premise that each container operates autonomously. Consequently, implementation poses a new set of problems for the project partners. For example, the container has its own control system which must run in an explosion protection zone. “This is a new application. Explosion protected versions of many items such as frequency converters are simply not available,” explained Lars Frye, the Project Manager in charge of the team which is building the demonstration system. To get around the problem, BTS has developed encapsulated pressure containment boxes. Space limitations inside the containers also present additional challenges. “We have to find a way of fitting everything into the space available,” said Frye. With the exception of the storage receptacles, most of the items in the containers are standard versions.
The project partners all benefit from this expertise, but the actual process remains proprietary to each company. This avoids conflicts between the partners, and each company is able to protect its own intellectual property. When active ingredients are produced in an F3 environment, great care must be taken to avoid process contamination from one stage to the next. “That is anything but trivial,” reported Gerhard Braun who is in charge of the Process Research & Development Dept. at Bayer Pharma. Braun hopes that state-of-the-art online instrumentation and leading-edge analysis methodologies will be introduced along with the containers in pharmaceutical production, eliminating the need for offline verification.
If the active ingredient and the production process meet expectations, market introduction could take place in 2016. A 75% yield in container-based production should be achievable, which is comparable with batch production yields. Process-intensified reactors designed for smaller volumes along with high-energy mixers which have their origin in microprocess technology will be used in the production process.
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