Bioburden

Testing 101 Learn how important bioburden

testing is to the medical device

manufacturing industry.

What is

Bioburden?

The amount of living cells on a surface.

Measured by colony-forming units per gram, or CFUs.

Why Test for

Bioburden?

Validating Sterilizations

Ensuring safety when using medical devices

Validating

Sterilizations

Bioburden testing measures the living cells on sterilized

products to ensure that they are fully sterilized.

Types of Sterilization Validations:

Radiation Sterilization

EO Sterilization

Radiation Sterilization

Process of using radiation to sterilize medical products

and pharmaceuticals.

EO Sterilization

Process of sterilizing medical devices with ethylene

oxide.

Bioburden

Tests Look at…

Anaerobic Bacteria

Aerobic Bacteria

Fungi and Spores

Bioburden

Standards

ISO 11737: lists the procedures for performing

bioburden testing

ISO 11135: Sterilization testing standards

EN 1174