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Feb 121 min read
Sterility Validation: Bacteriostasis & Fungistasis
The Bacteriostasis and Fungistasis (B&F) test is also known as the Sterility Suitability test. The test is performed on a sterile...
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Feb 123 min read
Sterility Testing for Medical Device
What is Sterile? According to ISO11737-1 , an item or product is considered sterile when it is free from viable microorganisms. Viable...
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Nov 5, 20232 min read
Sterilization Validation for Medical Devices: Navigating ISO 11135 and ISO 11137 Standards
The safety and effectiveness of medical devices are non-negotiable in the healthcare industry. Sterilization validation stands as a...
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Jan 11, 20233 min read
What is ISO 10993 all about?
ISO 10993 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the biological...
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Jan 11, 20233 min read
What is ISO 11137 All About?
ISO 11137 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the...
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Jan 11, 20232 min read
What is ISO 11135 All About?
ISO 11135:2014 is an international standard that provides guidelines for the sterilization of medical devices using ethylene oxide (EtO)....
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Jul 7, 20222 min read
What is the Difference Between Bioburden and Endotoxin Test?
What is Bioburden Testing? Bioburden is the population of viable microorganisms in or on a product, water, or raw material. Bioburden...
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May 26, 20223 min read
Bioburden Recovery Efficiency
What is Bioburden? Bioburden is the population of viable microorganisms present on or in a product. The bioburden of a product can come...
1,918 views0 comments
Dec 2, 20211 min read
Endotoxin Test for Medical Device
What is endotoxin? Endotoxin is a type of toxin that is produced by gram-negative bacteria. It can also be introduced into the body...
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Dec 2, 20215 min read
Bioburden Testing-Medical Device Testing
What Is Bioburden Testing Bioburden is the population of viable microorganisms in or on a product, water, or raw material. Bioburden test...
2,192 views0 comments
Dec 2, 20214 min read
Ethylene Oxide Residual Analysis
Ethylene Oxide Sterilization For Medical Device Ethylene Oxide (EO or EtO) is used to sterilize medical devices. Ethylene oxide gas...
2,598 views0 comments
Dec 2, 20215 min read
What is ISO 10993-7
ISO 10993-7 is a standard developed by the International Organization for Standardization (ISO) that outlines the requirements for...
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