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 Extractable
& Leachables testing of Polymer Device Components
The
examination of extractables and leachables from medical products
and devices is growing in importance. This has arisen from
ISO 10993 Standard Biological Evaluation of Medical Devices
– Part 18 Chemical Characterisation of Materials and
also from various guidelines produced by the FDA1,2. These
guidelines are concerned with various drug delivery devices,
such as meter dose inhalers (MDI) and dry powder inhalers
(DPI), and cover a wide range of aspects including extractables
and leachables from rubber and plastic components in these
devices.
About
the Author
Keith
Scott Joined Rapra Technology in 1982. After some
years involvement in the development of liquid polymer curing
systems and environmental aspects of polymer chemistry (e.g.
nitrosamine formation) he joined the Polymer Analysis Team
at Rapra in 1995. From 2000 until 2006, he had responsibility
for day-today operations, as Business Manager of the Polymer
Analysis Team. Keith has become increasing involved in managing
various projects for the medical and pharmaceutical sector
and at the start of 2007 become the Technical Manager of the
Pharmaceutical Solutions Team at Rapra Technology which specialises
in providing analytical solutions to this sector with particular
emphasis on Extractables and Leachables testing of polymers.
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