IRASM  Industrial Sterilization

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Brief history of industrial sterilization

An item, a solution or a volume is defined as "sterile" if it is free of viable microorganisms. Sterilization is a procedure resulting in sterile status. These unambiguous definitions had to be changed when industrial sterilization appears. Sterile status of a multitude of items (e.g. "a lot") had to be defined then. It was discovered that, it is inevitable a probability a microorganism to survive on a treated item, quite indifferent the sterilization conditions is.

Sterility of medical devices became important in the middle of XIX century after the discovery of microorganisms and their implication in wound infection. In time, flame, boiling water, alcohol, other liquid or gaseous chemicals, UV light or ionizing radiation was used for sterilization. At the beginning medical device sterility was obtained at the place of medical intervention. It was the case of surgery instrumentation, syringes etc.

The need for more efficient and safer medical intervention imposed the appearance of apparatus where sterilization process could be controlled. Autoclaves were invented and spread.

more about industrial sterilization

 
As a follow up of explosive development of plastics industry, new type of medical devices were invented that can be manufactured only from macromolecules. They brought a revolution in the medical act improving abruptly healthcare efficiency. In the same time plastics based packaging industry developed. A sterilized medical device, properly sealed, could be preserved sterile for long time.
Plastics are cheep being possible to manufacture single-use items in large quantities.
Cold types of sterilization were necessary because heating plastics physical dimensions are changed and some chemical properties are modified.

At the early '60 ethylene oxide (ETO) sterilization appeared giving birth to industrial sterilization. Sterilization process could be performed in dedicated plants away of medical act place.
It was mandatory medical devices to be stamped "sterile" to identify both the quality obtained somewhere else and the responsible company.
At quite the same moment irradiation sterilization emerged. Being more expensive it had to wait a decade before a positive trend stabilized.

In the years '70 the limits and disadvantages of ETO revealed.
It is flammable, toxic, carcinogenic and has a strong tendency to be absorbed in plastics. Desorbtion takes even a few weeks.
The tests for identify the remained ETO in medical devices, the costs for neutralization of spared gas before releasing into the air, the technological costs for safety and for workers healthcare, the costs for items quarantine before releasing to the market, became important.

In such conditions, irradiation sterilization - also a cold process, totally safe for the end-user imposed and can be considered the sterilization procedure of the future.
The sterilized medical devices need no quarantine period. In industrial irradiation facilities the only sterilization parameter is the time, the procedure being ease controlled and reliable.

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