Production conversion and newbuild

The former EBEWE Pharma Ges.m.b.H. Nfg. KG today belongs to the Sandoz Group (Novartis) and specialises in developing and manufacturing sterile injectable oncology and immunology products.

io-consultants was commissioned to modernise and extend the company’s production site in Unterach, Austria. The company focussed on reorganising production so that large quantities, small batches and limited runs of different products can be realised with minimum product changeover times. To ensure efficient and flexible operations, all the production lines were converted into multi-purpose units with a number of preparation tanks and isolators. Different solutions of highly active substances can now be mixed without any risk of cross-contamination. Each vial line can process up to three products per day, and fully automated CIP/SIP systems ensure short changeover times.

As product features make final sterilisation impossible, aseptic filling lines had to be installed for vials and pre-filled syringes. io-consultants opted for a classic clean room concept (class A with class B background) which makes easy changeovers and flexible use of the production lines possible.

The two biggest challenges of the project were increasing the production capacities while at the same time keeping within the available space and optimising the material and personnel flows.

io-consultants’ concept provided for uninterrupted production all through the renovation measures and the seamless adaptation of the supply and disposal processes.

The newbuild for pre-filled syringe production, which began initial operations in mid-2011, is considered one of the world’s state-of-the-art facilities. Material flows for preparation, filling and packaging are arranged vertically on three levels.

Production conversion and newbuild

Pharma/Biotech planning

Unterach, Austria

At the EBEWE site in Unterach, Austria, constant growth and new GMP requirements necessitated converting the six production lines and adding another production building for pre-filled syringes. io consultants developed a flexible multi-stage concept for these projects. With its comprehensive know-how of sterile technology and containment, io-consultants ensured that all project stages were completed according to GMP standards, on schedule, and with state-of-the-art technology.

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Tim Walter Business Unit Manager Phone: +49 (0) 62 21 / 379-111