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Bioburden Testing 101

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DocKetchum

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

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Bioburden Testing 101 Learn how important bioburden testing is to the medical device manufacturing industry.
What is Bioburden?
ο‚› The amount of living cells on a surface. ο‚› Measured by colony-forming units per gram, or CFUs.
Why Test for Bioburden?
ο‚› Validating Sterilizations ο‚› Ensuring safety when using medical devices
Validating Sterilizations
ο‚› Bioburden testing measures the living cells on sterilized products to ensure that they are fully sterilized. ο‚› Types of Sterilization Validations: ο‚› ο‚› Radiation Sterilization EO Sterilization
Radiation Sterilization ο‚› Process of using radiation to sterilize medical products and pharmaceuticals.
EO Sterilization ο‚› Process oxide. of sterilizing medical devices with ethylene
Bioburden Tests Look at…
ο‚› Anaerobic Bacteria ο‚› Aerobic Bacteria ο‚› Fungi and Spores
Bioburden Standards
ο‚› ISO 11737: lists the procedures for performing bioburden testing ο‚› ISO 11135: Sterilization testing standards ο‚› EN 1174

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