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Production plant for highly active substances at
Roche Basel

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VTU Engineering was commissioned by Roche Basel with the general planning of a plant for the production of highly active substances. The goal was to integrate the plant in an existing building while at the same time meeting high demands for employee protection, GMP and flexibility in a tight space.
Roche is a global company, headquartered in Basel, with a
pioneering role in the research and development of drugs
and diagnostics. A new plant for the commercial production
of new products and their intermediates and their market
launch was installed in an existing building on the Basel site.

Roche commissioned VTU Engineering with the general planning of the entire project in the basic and detail engineering. The planning scope covered the production plant including ancillary equipment, infrastructure facilities, washing and dispensing area, and adaptation of the building and building infrastructure for the integration and operation of the new plant. The plant was designed and developed so that substances up to category 3B (IOEL between 50 ng/m3 and 1 µg/m3) can be processed or produced safely. The plant was integrated in the existing production building as a closed unit (house-in-house concept) to ensure its compliance with the occupational health requirements for these highly active substances and the applicable GMP requirements for ensuring the required product quality.

Due to short production campaigns and changing launch
scenarios, the demands on the plant's productivity, efficiency, cleanability and flexibility were very high. It has to be possible for product change-overs and retooling operations to take place within an optimum short time frame. The design therefore had to take into account ergonomic and easy operation coupled with effective configuration options and dedicated plant sections. To satisfy these requirements and to comply with the applicable hygiene concept, certain plant sections were fitted with isolators or were shielded from the environment using containment systems.

The use of corrosion-resistant materials such as enamelled steel, Hastelloy and tantalum allows the plant to be used flexibly (multi-purpose unit).

VTU Engineering acted as the general planner for this project and coordinated all the other planning specialists from the subsections dealing with automation, electrical, plumbing, building, technical building equipment and 3D design. A project office accommodating the entire planning and design team, including Roche's project managers and the future operators’ representatives, was set up close to the plant location to facilitate effective communication within the project team. As a result of this very close cooperation, it was possible to incorporate the customer's wishes and ideas in the design and planning at the best.

The installation work was completed at the end of December 2015. The OQ activities and supporting activities, such as plant maintenance planning, spare parts procurement and employee training, are currently underway. VTU continues to support Roche with these activities until handover of the plant to the operator.

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