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February 11, 2008

Three mobile reactors for hazardous chemistry

Gerald Ondrey

On the international chemicals markets, hazardous chemistry and custom synthesis for the production of active pharmaceutical ingredients and their precursors represent an attractive combination. Besides the additional capacities, however, customers are also calling for an increasing flexibility regarding the dimensioning of the production facilities. Demand has been identified in particular in the segment between laboratory scale and industrial scale volumes, like that usually needed for projects in the clinical trial phases 1 and 2. In line with this trend, a pilot plant with three reactors of different sizes has been realized at Novasep Synthesis in Leverkusen, Germany (www.novasep.com).

Dynamit Nobel GmbH Explosivstoff und Systemtechnik, a company of the French Novasep Group, invested around 1.5-million euros into the mid-size plant. “Such a pilot-plant capacity was needed at short notice and realized to create a sufficient project pipeline for future growth in the midsize production segment,” says managing director Dr. Klaus Delpy, who is also a member of the management board of the Novasep Group and in charge of production. “Already today we clearly differ from our competitors on the custom synthesis market. The acceptance of hazardous chemistry in the field of pharmaceuticals/GMP is growing because these technologies offer advantages in the synthesis of increasingly sophisticated molecules,” he says.

Demand for commercial-scale quantities of the top products offered by Novasep Synthesis has increased continuously over the past decade. As a consequence, the company massively extended its GMP production capacities through the construction of new plants and the extension and upgrading of several existing production facilities.

During the same period, however, the pilot-plant capacities were only extended under-proportionally. Novasep Synthesis currently operates three pilot-scale lines in the field of GMP. In these lines, it produces APIs (active pharmaceutical ingredients) and intermediates for pharmaceutical projects that are currently undergoing the clinical trial phases. Typical volumes range between 10 and 250 kg. Moreover, this is where the processes developed in the laboratory are verified at a semi-commercial scale. In the case of a future commercialization, the customer’s demand will multiply; the products are then transferred to the commercial volume production facilities.

Novasep Synthesis thus needed these additional pilot-scale capacities in order not to have to reject new projects.
The technical requirements of the facility include:

•Sufficient space for the operation of three to five reactors and the corresponding separation technology: filtration/drying/distillation, and so on
• Capacity: around ten to 100 kg of product per batch, which means vessel sizes of 100, 250 and 500 L
• High flexibility regarding the combination of components to form systems matching the respective process requirements
• Separate building sections for reaction room and other rooms for monitoring and technical facilities (control room)
• Good tie-in into the existing plant infrastructure: transport, analytical laboratory, monitoring and control
• Use of all core technologies of the Leverkusen facilities (focus on hazardous reactions)
• Sustainable concept regarding capacity and variability

Following a construction time of nine months, the pilot plant started test operation in late 2006. Already during the test phase, minor projects were executed. The plant has been operating at its design capacity since spring 2007.
The plant is operated according to a three-shift scheme: five days/week, 24 h/d.

The pilot-scale plant is placed in an annex to the R&D building and consists of two floors where the process units are housed. This infrastructure allows for an optimum collaboration between the chemists in the R&D department and the staff operating the plant. After developing the synthesis process in the laboratory and thanks to the units close to production, the chemical processes can then be reliably mapped to ensure an optimum scale-up for a future commercial-size production on the premises.

As always at Novasep Synthesis, the process plants are designed as multi-purpose plants and suited for test series and the small volume production of intermediate and end products (five to 50 kg per batch) for the chemical and pharmaceutical industry, also under GMP. Just like for the rest of the Leverkusen site, the focus of the pilot scale plant is on hazardous chemistry. In principle, all safety-relevant details for industrial-scale production were also implemented in the laboratory-scale plant. The view into the laboratory room through the safety glass windows of the control room allows monitoring critical process steps. This way it is possible to reliably and safely operate hazardous processes such as reactions involving hydrazoic acid, the production of tetrazoles as well as highly explosive Grignard reactions in this plant. Moreover, the plant is also suited for handling highly toxic substances, such as isocyanates and azides, on a pilot-plant scale.

Another aspect to be highlighted is the flexibility of the plant units: all reactors and also other plant components are mounted on mobile skids. Owing to this modular system the individual components can be combined in any sequence. The system offers nearly the same flexibility as an organic preparative laboratory.

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