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Sterilisation of Polymer Healthcare Products
The use of
polymers in medical technology continues to grow and
provides major business opportunities for companies who
service the medical industry. Sterilisation has always
been challenging but sterilisation of polymer healthcare
products is an even greater challenge – how do you
sterilise without adversely affecting the end use or the
end user? This comprehensive reference supplies insights
into this developing field.
The recent publication,
“Sterilisation of Polymer Healthcare Products” authored by
Wayne Rogers and published by Rapra Technology
offers a thorough description of the conventional methods
of ethylene oxide, gamma and electron-beam radiation,
steam and dry heat sterilisation as well as covering newer
methods such as hydrogen peroxide/plasma, gluteraldehyde,
steam – formaldehyde, peracetic acid, chlorine dioxide and
ozone.
With the
many possible ways to sterilise healthcare products, and
new techniques being developed all the time, the author
identifies the variety of factors and functions that must
be taken into account, such as the requirement for an
understanding of physical, chemical and biological
properties, design and manufacturing processes, quality
control and regulatory issues.
This book
discusses the evaluation of candidate materials and
components for compatibility with the different
sterilisation methods. From this point methods may be
chosen and materials screened for biocompatibility,
devices manufactured and samples tested, and a validation
process chosen.
Sterilisation of Healthcare Products is a necessary and
worthwhile reference for medical device manufacturers and
polymer suppliers, as well as purchasing and quality
assurance managers in the healthcare industry. It is
designed to be of use to anyone already working in the
field of sterilisation of healthcare products but it will
be equally useful to someone about to start working in the
field.
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About
the author...
Wayne
Rogers’ interest in sterilisation and polymers began
34 years ago when he worked at the Castle Steriliser
Research Laboratory on the feasibility of using
sterilisers in military field hospital units. He has
since continued to work in the healthcare sector for
UCLA, Pharmaseal Laboratories, Baxter Travenol,
McGaw Laboratories, in Central Services at a large
hospital, Syntex and for an Eli Lilly subsidiary
where he developed, installed and validated a unique
ethylene sterilisation process.
Wayne
has served on the Editorial Advisory Board of
Medical Device and Diagnostic Industry Magazine (MDDI)
for over 15 years, and is also the co-author of a
Rapra Review Report entitled Polymers in Medical
Applications. |
Following are Some of the important highlights of the
report :
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Sterilisation of healthcare products and polymers is a
special process which renders a product free of all forms
of viable micro-organisms. It is expressed as the
probability of a certain number of micro-organisms capable
of surviving.
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Validation
of sterilisation is a documented procedure demonstrating
that a prescribed specification has been met, by obtaining
data, recording, and interpreting results that show the
process will consistently product free of micro-organism
with a high degree of assurance and confidence.
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Differences
between countries and sterilisation methods do exist.
There are several standards setting organizations involved
in sterilisation: Parenteral Drug Association (PDA),
Health Industry Manufacturing Association (HIMA), United
States Pharmacopoeia (USP), American Association of
Medical Instrumentation (AAMI), Community for European
Normalisation (CEN), and ISO.
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There are
detailed requirements for various methods that include
physical/chemical qualifications. The microbiological
qualification step possibly constitutes one of the most
important aspects of process qualification for many
companies because many companies today deal with contract
facilities and sterilizers.
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