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