A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 12th Year of Publication
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Cover Story

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.

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 :

  • 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.

  • 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.

  • 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.

  • 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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