Testing

What does Post-Impressionist art have to do with
Sterilization?

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

Labcon Products come with 10-6 Sterility Assurance Level

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.

FDA Approved

The sterilization process meets the U.S. FDA regulation for a valid process and the products can be labeled sterile.

Audited

Labcon sterile products are independently audited as required for compliance with ANSI/AAMI/ISO 11137 standards.

Confirmed Sterility

An independent laboratory confirms the sterility of Labcon products through continous biological testing.

Human Diagnostics

Our products meet U.S. FDA and international standards for sterile products that can be used for human diagnostic procedures.

Clinical Procedures

Labcon sterile products comply with U.S. FDA listing standards and can be used in appropriate medical and clinical protocols.

Research

All our sterile products meet purity standards for reseach applications like vaccine research, pharmaceuticals, and tissue culture.


Highest Level of Purity

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.

SAL
Presterile

1000
Per Million
10-3 Sterile
100
Per Million
10-4 Sterile
10
Per Million
10-5 Sterile
1
Per Million
10-6 Sterile

How much contamination are you paying for?

Want more information about our quality?

Click the link to see more about the focus we put on our product testing and consistency.