The 1884 painting "Un dimanche après-midi à l'Île de la Grande Jatte" by Georges Seurat is made up of about 4 million paint dots. Sterilization to 10-6 from Labcon means 4 dots in this painting might have a positive result. In the "Presterilized" product others provide there might be 4000 positive dots.OUR TESTING
There are two kinds of products offered for laboratory disposables that are presented as sterile. The validated sterile products provided by Labcon and those labeled presterilized from others that follow a "presumed sterile" regime.
Validated sterile products can be used for human diagnostics, research, clinical, and all general laboratory uses including clinical and preclinical trials. Validated sterile products are just that. They have undergone a sterilization process that has been validated to achieve a sterility assurance level that meets U.S. FDA regulations and ISO standards. This is known as their (SAL) level. These products are confirmed to be sterile by biological testing and required ongoing surveillance testing.
Presterilized, or presumed sterile products can be legally used only for research or general laboratory applications that do not involve any diagnostic, clinical, or preclinical processes. These products receive processing that assumes the product is sterile based on past experience. No ongoing surveillance testing or lab testing is completed. These items can be identified separately from validated sterile items by their labeling of "Presterilized" or in some cases "For Research Use Only" or "Irradiated".
All Labcon sterile products are validated using an ISO/ANSI/AAMI 11137 procedure approved by the U.S. FDA and monitored by an independent laboratory. Our sterility assurance level (SAL) is 10-6 and guarantees the less than 1 million possibility of a positive viable organism in our sterilized products.
Labcon only offers Sterile products that truly are. We don't make the presumed sterile "presterilized" products others make. We make only products sterilized to a validated sterility assurance level of 10-6.
Below is a chart that shows the relationship of the different types of sterilization available to laboratories and the potential for contamination of each level.