The aim of bioburden testing is to measure the total number of viable micro-organisms (total microbial count) on a medical device prior to its final sterilization before implantation or use.

Oct 10, 2025 · Bioburden is the population of viable microorganisms on a product, surface, or substance before sterilization or decontamination. These can include bacteria, fungi, and spores.

Bioburden is a term used to describe the microbial numbers on a surface (or complete item) or inside a device or from a portion of liquid.

Nov 16, 2022 · Bioburden describes the number of viable microorganisms present in a product or on a sterile barrier system. The bioburden may be introduced by various sources like raw materials, …

Aug 15, 2025 · Bioburden testing involves the quantitative assessment of microbial load on a product, raw material, or in-process sample. It determines the number of viable microorganisms present, such …

What is bioburden? Bioburden is the quantity and types of native bacterial and fungal flora present on or in a device, substrate, or chemical (test unit). Bioburden plays a large role in determining what is …

Feb 21, 2025 · Bioburden is a term used to describe the total number of viable microorganisms on or within a product. Bioburden determinations in drugs, medical devices, and biologics are a …

Aug 19, 2025 · Bioburden refers to the population of viable microorganisms, including bacteria, fungi, and spores, present on or within a product before sterilization. Managing bioburden is a key aspect …

Therefore, bioburden refers to the amount of living organisms – like bacteria or fungi- naturally present on a device. Bioburden testing is the process of determining the total number of viable …

Bioburden testing or Microbial testing is a quality control process that detects and quantifies microbial contamination of a product at different stages of production i.e., from initial manufacturing to final …