Press Release

STEMart, a U.S.-based provider of comprehensive services for all stages of medical device development, has recently introduced Bioburden Tissue Testing services for medical applications, including Aerobic Count, Anaerobic Count, Fungi/Mold Count, and Spore Count, all of which follow the guidance of Radiation Sterilization standards (ANSI/AAMI/ISO 11137-1 & 2) and the EO Sterilization standard (ANSI/AAMI/ISO 11135).

Tissues should be routinely tested to demonstrate that tissue processing is under control. The appropriate sampling frequency and quantity depend on many factors, including sterility assurance levels, product types, sterilization types, environmental controls, and manufacturing process controls.

Bioburden tissue testing determines the total number of viable aerobic bacteria, molds and yeasts within tissues or solutions. It is suitable for use with any tissue product requiring controlled bioburden counts, typically as part of a sterilization program. The bioburden testing serves as an early warning for potential production hindrances that could lead to inadequate sterilization or disinfection treatments, as well as calculating the required dosage for effective radiation sterilization.

STEMart now offers four types of bioburden testing, including Aerobic Count, Anaerobic Count, Fungi/Mold Count, and Spore Count. In addition, the Recovery Efficiency Test and the Most Probable Number Test are also available. All of these bioburden tissue testing services strictly follow the guidance of the EO Sterilization standard (ISO 11135) and the Radiation Sterilization standards (ISO 11137-1, ISO 11137-2).

In terms of the aerobic count test, which enumerates the overall levels of microorganisms present in an aerobic environment, typically including bacteria, fungi/mold, and yeast, is used for all bioburden determinations, and additional optional tests can be applied to complement the supplemental data. Meanwhile, the anaerobic count test selects anaerobic organisms by culturing them in an anaerobic environment and is usually performed with biological samples and components.

As for the spore count test, it selects bacterial spores by heating them to eliminate the undesired bacteria. It often runs in conjunction with an aerobic count test to determine the percentage of spores within the microbial population, which can be an important factor in sterilization validation. Additionally, recovery efficiency tests need to be performed to validate bioburden tests. Exhaustive recovery and product inoculation are two general methods for performing recovery efficiency testing. In the meantime, the recovery efficiency test is commonly recommended to be completed prior to the bioburden testing.

If you have additional questions regarding these Bioburden Tissue Testing services for medical devices or would like to know more about STEMart's medical device development service, please visit https://www.ste-mart.com.

About STEMart

STEMart is an industry-leading eCommerce platform incorporated with an extensive global footprint and a broad portfolio of more than 10,000 products. It aims to provide better lab materials, medical instruments and consumables, excellent technologies, and high-quality services to global customers in the fields of science, technology, and engineering, from the discovery stage upward to the manufacturing process. STEMart is dedicated to enhancing research and biotech production with simpler and safer protocols in order to access better health worldwide.

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