Rapra launches training for healthcare manufacturing professionals

Rapra Technology, Europe's leading independent polymer specialist, is launching a number of bespoke training courses to help healthcare industry professionals to address the technical and materials consequences of new and forthcoming product legislation.

The first such course will be on Getting Ready for ISO 10993 Pt 18. The ISO 10993 standard, Biological Evaluation of Medical Devices, Part 18: Chemical Characterisation of materials, is set to change radically the approach adopted by many manufacturers to demonstrate the biological safety of their devices for the purposes of device registration. Part 18, for example, will instigate a move away from animal testing and towards more chemical-based assessments of the make-up and quantity of all the chemical components in contact with the body. ISO 10993 Pt 18 provides an outline of the information that will be necessary to enable a full biological risk assessment to be conducted.

The chemical characterisation information generated will be used:

• To assess the biological safety of the device

• To demonstrate equivalence with a clinically established device

• To screen potential new materials for specific applications

• To establish scale-up and development uniformity

The course will be held at Rapra's site in Shawbury, Shropshire on 5 June and on 23 October and will provide:

• a guide to the methodology for the chemical characterisation of the commonly used materials

• an overview of the analytical techniques used and their strengths and limitations

• an introduction to the practicalities of sample preparation and solvent extraction

• an introduction to the toxicological interpretation of the data generated.

• case studies detailing the characterisation of different materials

• an opportunity for Q&A with some of Rapra's senior analytical staff.