Bioburden testing is crucial in the medical device manufacturing industry as it measures the number of living cells on surfaces, ensuring sterilization and safety of medical devices. The testing measures anaerobic and aerobic bacteria, fungi, and spores, validating processes such as radiation and ethylene oxide sterilization. Key standards include ISO 11737 for bioburden testing procedures and ISO 11135 for sterilization testing.

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