Sterility Assurance Level (SAL) Analysis

In microbiology, the sterility assurance level (SAL) is the probability that a sterilized unit will still not be sterile. Since the probability of survival of a single microorganism is never zero, it is never possible to prove that all organisms were destroyed.

A sterility assurance level (SAL) is normally expressed as 10-n, and the most commonly used values ​​for sterilization are 10-3 or 10-6. The sterility assurance level expression 10-n is a quantitative value to ensure sterility. When this quantitative value is applied, a higher sterility assurance is obtained with a lower sterility assurance level.

There are many factors in choosing an appropriate level of sterility assurance for medical devices, but as this choice is directly related to the sterilization dose, this decision is critical to making a sterile claim on any product and the impact on product design, e.g. material selection, customer needs and wishes and functionality are taken into account. A sterile medical device is one that is free from living microorganisms. For a sterile medical device, this is the case.can be obtained in the following ways:

• A terminal sterilization process
• Sterilization of components followed by sterile filtration and aseptic filling into a sterile container
• A combination of chemical and physical sterilization and aseptic processing

The sterility of any product is defined by the probability of having a live microorganism on the product after it has been sterilized. This possibility is called the sterility assurance level (SAL). For example, a value of 10-6 is lower than a value of 10-3SAL and therefore provides greater assurance of sterility. The probability can never be reduced to zero, but is expected to drop to very low numbers.

For sterilization of all medical devices, the most exacting SAL value should be selected and used based on the product's ability to work after sterilization.

The standard on which this is based is ANSI/AAMI ST67 Sterilization of healthcare products - Requirements and guidance for selecting a sterility assurance level (SAL) for sterile labeled products.

Our organization also provides sterility assurance level (SAL) analysis services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.