From Sterilisation of Polymer Healthcare Products

3.1 General Considerations

In the classical sense, sterilisation has been defined as an absolute process that destroys or eliminates all viable organisms [1]. In a practical sense, however, sterilisation is better defined as processes capable of delivering a certain probability [2] that an exposed or treated product, polymer or material, is free from viable micro-organisms, including resistant microbial spores such as Bacillus anthracis (Anthrax), or prions in blood. The term sterilisation has previously been misunderstood, abused or confused with lesser methods of eliminating viable micro-organisms, such as commercial sterilisation, disinfection, decontamination, sanitisation or antisepsis. These methods are not capable of total elimination or destruction of all types of micro-organisms.

Sterilisation, by definition, is capable of destroying or eliminating the most resistant microbial bacterial spores that are capable of surviving most severe environmental conditions such as outer Space, Pharaoh s tombs, the Himalayas, Death Valley (USA) or the Tundra. However, more resistant forms of organism, e.g., prions, may be even more difficult to destroy or inactivate. Sterilisation methods can be categorised as physical, chemical, or physical-chemical, such as heat, chemicals or heat-chemicals, respectively. There are no biological sterilisation agents. Antibiotics would come the closest, but there is no antibiotic that will kill all micro-organisms, e.g., spores in a dormant state, etc.

The physical and chemical types of agents capable of achieving sterilisation for use with healthcare products are therefore limited. The conventional types are moist heat (autoclaving), dry heat, chemical sterilisation, (e.g., EO, formaldehyde, oxidising agents), and ionising irradiation, (e.g., electron...

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Products & Services
Water Disinfection Systems
Water disinfection systems treat water to inactivate, destroy, and/or remove pathogenic bacteria, viruses, protozoa, and other parasites. Common methods include chlorination and alternative disinfectants.
Steamers and Steam Generators
Steamers and steam generators produce steam vapor for cleaning, oxidation, and other process functions.
Bioanalytical Services
Bioanalytical services encompass pharmaceutical, agricultural, biological, microbial, and other life science testing and analysis.
Autoclaves and Sterilizers
Autoclaves are used for applications requiring constant pressure and temperature for long periods of time.  Common applications include the sterilization of instruments and polymerization of rubbers and plastics.
Biocides
Biocides and cidal agents are functional chemicals used to kill microbes, vegetation, insects and animal pests.

Topics of Interest

4.1 Background and Definition Successful sterility assurance and validation is dependent on adequate application of statistics to products and the processes. To fully appreciate the role statistics...

1.1 Purpose Sterilisation of healthcare products and polymeric materials is a specialised field requiring an interfacial area of investigation, discipline and information. There is much more to...

2.4 General Considerations of Products, Polymers, and Materials for Sterilisation The processes capable of sterilising product, polymers or material without adversely affecting their attributes,...

Overview Sterilisation of healthcare products and polymers is a special process. It is a challenged process of the highest order used to render a product free of all forms of viable microorganisms.

In this book, current sterilisation agents and processes such as steam, steam-formaldehyde, EO, radiation and dry heat [1] will mainly be presented, with applications relating to hospital products,...