Bioburden Testing fulfills international standards for medical devices and pharmaceuticals by measuring the amount of living cells on a device.

1. Bioburden
Testing 101
Learn how important bioburden
testing is to the medical device
manufacturing industry.

2. What is
Bioburden?

3.  The
amount of living cells on a surface.
 Measured by colony-forming units per gram, or CFUs.

4. Why Test for
Bioburden?

5.  Validating
Sterilizations
 Ensuring safety when using medical devices

6. Validating
Sterilizations

7.  Bioburden
testing measures the living cells on sterilized
products to ensure that they are fully sterilized.
 Types of Sterilization Validations:


Radiation Sterilization
EO Sterilization

8. Radiation Sterilization
 Process
of using radiation to sterilize medical products
and pharmaceuticals.

9. EO Sterilization
 Process
oxide.
of sterilizing medical devices with ethylene

10. Bioburden
Tests Look at…

11.  Anaerobic
Bacteria
 Aerobic Bacteria
 Fungi and Spores

12. Bioburden
Standards

13.  ISO
11737: lists the procedures for performing
bioburden testing
 ISO 11135: Sterilization testing standards
 EN 1174