Sterility Assurance Level (SAL)

 What is sterility assurance Level?

  • Sterility Assurance Level is a abbreviation of SAL.
  • The SAL concerns with the potential for bacteria, viruses, spores, or other microbes to survive the sterilization procedure of objects including medical equipment, pharmaceuticals, medications, protective apparel for cleanrooms, and more.
  • The likelihood of a single viable bacterium remaining after sterilization is complete is shown here as a log reduction.
  • A Log 6 decrease, recorded as SAL of 10-6, is regarded as the appropriate SAL for sterilization. It represents a one in a million likelihood of one being present.
  •  The maker must demonstrate that the sterilizer can deliver the SAL.
  • The phrases “sterile” and “sterilized” should also be taken into account. When a process is successful and an item is sterile, it signifies that there are no living organisms present.
  • Nevertheless, there are a number of reasons why it might not end up being sterile. It was first put through a sterile barrier system for sterilization.
  • A barrier that is the bare minimum necessary to prevent the entry of germs and permits aseptic presentation of the product at the point of use is referred to as a sterile barrier system.
  • If a sterile barrier system is utilized, such as a plastic-paper pouch or sterilizations wrap, the contents (assuming they were sterilized) are still sterile as long as the pack was dry when it emerged from the autoclave and remains intact until the subsequent point of use.
  • Contrarily, a sterility maintenance cover, also called a dust cover, is designed to fit over a sterile barrier system.
  • It may be acceptable to sterilize equipment or devices unwrapped and then wrap them when they come out of the autoclave, depending on the laws or recommendations in your location.
  • In that circumstance, they cannot be regarded as sterile after coming out of the steam sterilizing.
SAL ValueIdeal Forlevel of sterilization
10-3It is a designation that applies to low-level sterilization. Heat-sensitive re-usable medical devices, under the precondition of validated cleaning efficacy of >4 lg increments,Low-level sterilization
10-4It is considered high-level sterilization suitable for heat-resistant medical instruments.High-level sterilization
10-6The standard for injectables, or anything that enters the body anywhere other than through the digestive tractPharmaceutical sterilization

How is sterility assurance level (SAL) measured?

  • SAL is addressing is the chance of survival of a viable microorganism, such as bacteria.
  • A value of 10-5 proposes that only 1 in 100,000 will survive sterilization.
  • Where,10-6, recommend that the survival rate will only be 1 in 1,000,000.
  • By processing repetitively, one can be assured that your odds are very, very high against an item being compromised by any living bacteria, viruses, spores, or other microorganisms.
  • Depending on the application, you might need 10-6 rather than 10-5 to ensure testing integrity in the vials, such as vials for collection of blood samples compared to squirt bottles of dish detergent. Because most home microbes are killed by detergent, might only need 10-3 for the spray bottles.
Sterility Assurance Level (SAL)


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