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Plasticizers for Medical Devices

The presentation will give an overview on the most recent developments regarding plasticizers for flexible PVC in medical devices. Regulatory agencies around the world have evaluated the use of DEHP in medical devices during the last years. Some of them are currently in the stage of updating these evaluations. The most recent status of these efforts will be reported.

Risk assessment and risk benefit analysis for the medical sector are covered by practical examples. BASF's plasticizer Hexamoll® DINCH will be taken as a practical example and it will be shown what parameters are needed to support the safe use of any additive. Plasticizer migration, which in case of medical devices is the key parameter to determine patient exposure, will be compared for several plasticizers.

Neonatal exposure against plasticizers and the risk assessment for the application enteral nutrition will be shown as case study using the toxicological data available for the different plasticizers.
 


Carsten Goebel received his Diploma in Industrial Engineering for Technical Chemistry after studying at the Technical University Berlin, Germany and the Dublin City University, Ireland in February 2000.

In March 2000 he joined BASF's Global Marketing Group for Plasticizers as Product Manager, where he was responsible for Plasticizer Business Development. Following a position in Strategic Marketing for Plasticizers was the responsibility for Communications of the Petrochemicals Division from 2003 until end of 2006.

Early 2007 he transferred to BASF South East Asia where he is until today responsible for BASF's speciality plasticizer portfolio, including Hexamoll DINCH, in the Asia Pacific region.

 

Carsten Goebel - (Manager Asia Pacific)
Speciality Plasticizers, Petrochemicals Division

BASF South East Asia Pte Ltd.
carsten.goebel@basf.com


Rainer Otter received his Diploma in Biochemistry, Physiological Chemistry and Pharmacology and his PhD from the University of Tübingen in Germany.

In 1988 he joined BASF's Central Research, moved 1993 to BASF's Department of Toxicology, completing in parallel his continuing education in Toxicology in Germany and the United Kingdom (EUROTOX registered Toxicologist).

From 1999 to 2004 he was responsible as product safety manager within BASF's Petrochemicals Division for e.g. plasticizers and solvents.

Since November 2004 he is in charge of Regulatory Toxicology at BASF's Global Product Safety Department.

Since 1999 he is member of several national and international toxicological expert groups.


Dr. Rainer Otter
Head Regulatory Toxicology Chemicals
Department Product Safety, Regulations, Toxicology and Ecology
BASF SE, Germany

rainer.otter@basf.com