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Bioburden Testing: The Cornerstone of Medical Device Quality Assurance
In the medical device industry, maintaining high standards of quality is a necessity. Among the various components of quality assurance,...
Apr 223 min read
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1 comment
Whitepaper: Study on The Stability of Ethylene Oxide Residues Solution During Transportation
ISO 11135-7 provides guidelines for the Ethylene Oxide (EO) sterilization process and highlights the need to monitor residual Ethylene...
Aug 20, 20242 min read
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Biological Indicator Sterility Testing: A Step-by-Step Guide for Medical Device Manufacturers
Sterility of biological indicator testing is essential in the validation and monitoring of the sterilization process for medical devices,...
Jul 24, 20241 min read
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Whitepaper: Bacterial Endotoxin Kinetic Turbidimetric Interference Control Validation (Endotoxin Inhibition)
Assessing endotoxin levels in pharmaceutical drugs and medical devices is essential to prevent pyrogenic responses and septic shock in...
Jul 16, 20241 min read
47 views
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Whitepaper: Stability Study of Ethylene Oxide Solution Stored in 2°- 8°C
According to ISO 11135-7: Sterilization of healthcare products-Ethylene Oxide, when determining the suitability of Ethylene Oxide (EO)...
Jun 26, 20241 min read
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Step-by-Step Guide to Bioburden Testing in Medical Device Manufacturing
Bioburden is the population of viable microorganisms present on or in a product and/or a sterile barrier system. It is important to note...
Jun 5, 20242 min read
252 views
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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...
Feb 12, 20241 min read
1,928 views
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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...
Feb 12, 20243 min read
999 views
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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...
Nov 5, 20232 min read
142 views
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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...
Jan 11, 20233 min read
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What is ISO 11137 All About?
ISO 11137 is a standard developed by the International Organization for Standardization (ISO) that provides guidelines for the...
Jan 11, 20233 min read
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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)....
Jan 11, 20232 min read
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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...
Jul 7, 20222 min read
5,179 views
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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...
May 26, 20223 min read
2,152 views
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