Sterility assurance level, or SAL, is the chance that although something has been through the process of sterilization, there is still the potential the item is nonsterile as it is impossible to prove that every harmful organism has been destroyed. Sterility assurance level is a way of expressing the probability of a microorganism’s survival. The more effective the sterilization process, the lower the SAL.
Sterility of a product is determined by the probability of a microorganism on the product after it has been sterilized and is expressed as 10-n. A value between 10-3 and 10-6 is considered normal and most frequent. A lower SAL provides a greater assurance of sterility.
A sterilization process resulting in a SAL of 10-6 is used for any medical devices or products that are intended to come in contact with open skin or otherwise compromised tissues, for invasive products that will encounter tissues that are normally sterile, devices that are to be surgically implanted, and for any product with claims of sterile fluid pathways.
Contract Laboratory has received the following test requests regarding sterility assurance level:
- Analytical Chemistry laboratory needed for medical devices – 501k Submission testing: Cytotoxicity Sensitization Irritation Ames Mutagencity Product Sterility for final package (3 year expiry) Gamma Irradiation Testing – radiation dose, sterility validation method, sterility assurance level
- Canada microbiology laboratory needed for pharmaceutical sterilization validation and Sterility assurance testing
- FDA GLP GMP Contract Pharmaceutical laboratory needed for GMP Testing: analytical chemistry testing, microbiology testing, sterility assurance testing, and biocompatibility testing stability testing microbiology testing
- FDA GMP, GLP Laboratory needed for ASTM and ISO Biocompatibilty Testing, Sterility Assurance Testing and Packaging Integrity Testing for disposable medical device
- or view all sterility test requests
If your organization is in need of a laboratory to perform sterility testing, call us at 1-855-377-6821 or submit a sterility test request online.
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