bioburden testing 101
Post on 26-May-2015
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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
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