As a specific discipline, Sterilization has been with us for approximately 120 years, since the invention of the steam autoclave by Charles Chamberland in 1879. Though the efficiency, reliability, and performance monitoring of modern equipment is continually improving, the fundamental process hasn’t changed much so far.
Sterilization processes cannot be considered in isolation; instead, they are inextricably related to the sterilized product. They are also associated with the packaging of the fixed effect.
Except for the rare instances when the sterilizer can be located where the sterile goods are to be used, there is a need for the modern sterilized products to be packaged in a manner that will preserve their sterility during storage, handling, and transport. For a product fixed in its packaging, the packaging material must be compatible with the sterilization process. This requires both that the packaging tolerates the process without adverse effects on its performance characteristics and that it permits the attainment of the specified sterilization conditions in the product to be sterilized.
Traditional techniques of Sterilization:
The sterilization processes that have traditionally been used for medical products include steam, ethylene oxide (EtO), ionizing radiation (gamma or E-beam), low-temperature steam and formaldehyde, and dry heat (hot air). You can divide them into three methods like based on the nature of the sterilant and its reaction with microorganisms: physical processes, physicochemical processes, and chemical processes.
Chemical and physicochemical processes depend on direct physical contact between molecules of the sterilant and the microorganism to be killed. In consequence, access must be available to the surfaces of the product to be sterilized and the packaging material. It is essential for both to provide the required thermal energy by condensation of the steam and the required water for the protein hydrolysis reaction to occur.
Modern techniques of Sterilization:
You might to be curious to know that what is the new sterilization process? Then you need to know that often new is a marketing description for the latest outcome in a gradual development and refinement of an existing process. Continued development or improvement in one area allows, and sometimes requires, action in another. This advance may be driven by the product, the sterilization process, the packaging, economics, or other external forces.
Over the past few years, the development of the art of Sterilization seems to have accelerated, with the introduction of several new processes. It is a result both of increased concern over the toxicity of residuals and of the need to eliminate the use of chlorofluorocarbons (CFCs), which had previously been employed to minimize the flammability and explosion risks of the EU.
It is essential to consider that one must consider two very different fields of application for sterilization processes—industrial and hospital. Although the same level of sterility assurance should be provided in each case, the operational circumstances are sufficiently different that the two fields need to be considered separately.
On the flip side, in hospitals, too, we come across such a situation. A diverse range of reusable products will be processed after being subjected to a mostly unvalidated cleaning process. The extent and nature of residual soiling and bioburden will be unknown.
Validation of Sterilizer Processes:
In the development of new modern sterilization methods, a key consideration is data that is needed to demonstrate the efficiency of a process. Although in the United States, there is a well-defined process for review of new types of hospital sterilizers, this is not the case worldwide. Furthermore, the FDA approval system does not apply to sterilizers for use in the industry.
It is to be hoped that the standard will provide a format establishing a common standard for the acceptance or rejection of new sterilizing processes.
