The cleaning validation for the twin screw extruder in the Development & Transfer Center of Rottendorf Pharma GmbH in Ennigerloh has successfully been completed. With this, the complete equipment of the Center which was newly built in 2009 can be used under GMP conditions as well as under FDA conditions.
The already wide range of equipment for the production of clinical trial samples and small-scale batches is therewith extended by another interesting technology. Hot-melt extrusion by means of the twin screw extruder is particularly suited for improving the solubility and the bioavailability of poorly soluble APIs. Bruno Buss, Director of Development & Transfer is convinced that Rottendorf will be able to build on this in the future: ?It is planned to buy further auxiliary equipment for the twin screw extruder in order to better be able to respond to our customers? requirements.?
Rottendorf?s offer in the field of development and transfer covers in addition to special technologies such as hot-melt extrusion, hot-melt granulation and pelletizing also all standard technologies for the production of solid forms. Laboratory-scale lots below 1 kg as well as stability batches and clinical trial batches from 15 kg up to 150 kg can be produced.
Rottendorf Pharma is one of the leading pharmaceutical contract manufacturers for development, production and packaging of solid dosage forms in Europe. Besides the two sites in Germany the company is also represented by a subsidiary, Rottendorf Pharma S.A.S., in Valenciennes/France.
Rottendorf Pharma belongs to a nonprofit foundation and focuses not only on market success but also on social engagement.
For its 150 customers, among them a lot of the biggest Big Pharma companies, Rottendorf is an exclusive service provider who offers a maximum of production reliability and investment security in addition to modern production facilities and high potency technologies. Audited and approved by the internationally recognized FDA, the company is not only qualified for the European but also for the US market. Moreover, Rottendorf is optimally positioned for future challenges due to annual investments of several million Euros in the modernization and expansion of the facilities and technologies. In addition to contract manufacturing and contract packaging, the development of processes and formulations plays a decisive role in the future company strategy.
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