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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, particularly on medical devices with the sterile claim. This testing verifies the sterilization process lethality by confirming the absence of microbial growth from biological indicators after being exposed to the sterilization process. The unsuccessful inactivation of biological indicators indicates a process failure, thus necessitates
Jul 24, 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...
Jul 16, 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)...
Jun 26, 20241 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...
Jun 5, 20242 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 product for the purpose of finding if any inhibiting factors exist in the product which would invalidate a sterility test. The test method will therefore confirm the presence or absence of inhibitory substances in the medical devices that could affect the result of sterility test. The test is usually required during the course of validation
Feb 12, 20241 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...
Feb 12, 20243 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...
Nov 5, 20232 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...
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...
Jan 11, 20233 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)....
Jan 11, 20232 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 test determines the number of these microorganisms present, reported as colony forming units (CFU). The test usually involves an extraction step to remove the microorganisms followed by an enumeration or culturing technique to quantify the extracted organisms. Click here to learn more on Bioburden Testing. What is Bacterial Endotoxin Test? B
Jul 7, 20222 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...
May 26, 20223 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...
Dec 2, 20211 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...
Dec 2, 20215 min read