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Sterility Assurance Level (SAL) - A quick intro
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But you are not finished. Remember that FDA and other requirements require specific SALs. For invasive products you would be expected to have an SAL of at least 10-6. To ensure that your products have an SAL of at least 10-6 you need to take into consideration the number of microorganisms that will be expected to be introduced to your product, hence the importance of conducting regular Bioburden testing.
If your product – let’s say usually as 102 or 100 microorganisms living on the product – the best you can prove the half cycle sterilization has given you is 10-4. To ensure an SAL of at least 10-6 a method is used in Ethylene Oxide sterilization (which is referred to the overkill method) by doubling the length of the Half cycle. By doubling the time for sterilization exposure for routine processing you in effect impart a sterilization effectiveness of 10-12. Hence if you begin with 100 or 1000 microorganisms per device you will always be assured to have product that meets an SAL of at least 10-6.
CONCLUSION
Establishing a good bioburden program and controlled manufacturing process is the first step in being able to demonstrate that your products are meeting a required SAL. In all cases you should consult with your sterilization provider and/or laboratory used for evaluating your devices and biological indicators on ways to improve assurance.End of article