Question

If the final result of the sterilization process requires the absolute absence of living forms from the surface and bulk of the item:

• Which destructions implies this sterilization process?
• From Where comes the achievement of the sterility status?
• Provide one example of medical devices sterilization.

Answer 1

1.Which destructions implies this sterilization process?

Sterilization refers to any process that removes, kills, or deactivates every kind of life (in particular regarding microorganisms like fungi, bacteria, viruses, spores, unicellular eukaryotic organisms like Plasmodium, etc.) and other biological agents like prions present during a very very specific surface, object or fluid, as an example food or biological culture media. Sterilization are achieved through various means, including heat, chemicals, irradiation, high, and filtration. Sterilization is distinct from disinfection, sanitization, and pasteurization, therein those methods reduce instead of eliminate all sorts of life and biological agents present. After sterilization, an object is alleged as being sterile or aseptic.

2. From Where comes the achievement of the sterility status?

Sterility assurance level (SAL) is the probability that a single unit that has been subjected to sterilization nevertheless remains nonsterile.It is never possible to prove that all organisms have been destroyed, as the likelihood of survival of an individual microorganism is never zero. So SAL is used to express the probability of the survival.

3. Provide one example of medical devices sterilization?

Medical device manufacturers design their sterilization processes for an extremely low SAL, such as 10⁻⁶, which is a 1 in 1,000,000 chance of a non-sterile unit. SAL also describes the killing efficacy of a sterilization process. A very effective sterilization process has a very low SAL.