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Aug 20, 20242 min read
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...
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Jul 24, 20241 min read
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,...
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Jul 16, 20241 min read
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...
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Jun 26, 20241 min read
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)...
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Jun 5, 20242 min read
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...
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Feb 12, 20241 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 12, 20243 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...
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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...
508 views0 comments