Sterility Assurance Level (SAL) is a term used in microbiology to describe the probability of a single unit being non-sterile after it has been subjected to the sterilization process. For example, medical device manufacturers design their sterilization processes for an extremely low SAL. For instance, one in a million devices should be non sterile. SAL is also used to describe the efficacy of a sterilization process, where a very effective sterilization process has a very high SAL.

There are numerous ways to sterilize medical devices and there are harmonized standards applicable for each and every method. To maintain the highest sterility levels for three to five years, as required in these standards, the selection of the right packaging materials and the implementation of the correct cleaning and packaging procedures under a proper working environment are important.

Contact us for any assistance you may need in preparation or implementation of sterilization validation for your product. Training, step by step guidance, and onsite or online consulting is available. Also we offer complete third party lab services for medical device packaging and sterilization validation for any device and any risk classification.

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