TARYAG Laboratories offers the following services:
EO residuals testing on medical devices
When using EO as a sterilant, it is important to ensure that the levels of residual EO, ethylene chlorohydrin (ECH) and ethylene glycol (EG) pose a minimal risk to the patient in normal product use.
Biological indicator population enumeration
Biological indicator (BI) used for monitoring the EO process is inoculated Bacillus Atrophaeus carrier.
EO sterilization cycles are challenged with BI to demonstrate microorganism lethality produced during the sterilization. BI population enumeration test determines the number of spores on a BI and is typically used to verify the BI manufacturer’s labeled population. This test can also be used to enumerate survivors from a sterilization process to determine lethality rates and D-values.
Biological indicator sterility testing
During the sterilization process BIs will placed inside the worst case location of the insertion module, to represent a greater challenge to the sterilization process. Since such spores are usually challenging to sterilize, their absence in the final sample determines sterility assurance levels.
Product sterility testing
Is used to demonstrate that a sterilized product is free from contaminating microorganisms.It is necessary to qualify the procedure by demonstrating that the test articles to do not impart any anti-microbial growth properties to the test medium (sterility validation- bacteriostasis / fungistasis).
Sterility validation test (bacteriostasis / fungistasis)
The test is a validation of the product sterility test, to ensure that there is no inhibition of microbial growth due to the test sample materials after sterilization.
Bioburden method recovery / validation
The test is necessary to determine accurate product bioburden levels. It will demonstrate the efficiency of recovering microorganisms that are present on the particular product. The data collected is used to determine a recovery factor needs to be applied to the microbial content of the device.
Bioberden is used to evaluate the population of viable microorganisms on a product prior to sterilization. Bioburden enumeration should be validated to ensure that the method is effective, accurate, and reproducible in determining the material’s microbial load in a test article (bioburden recovery / validation).
LAL test / bacterial endotoxin
Bacterial endotoxins, also known as pyrogens or fever-causing toxins, are a concern for pharmaceutical and medical devices that are intended to come in contact with human blood. Traditional sterilization methods, such as irradiation and EO treatment are not reliable for removing endotoxin contamination. It is best to control the process and keep finished products relatively free of gram-negative organisms to reduce the risk of endotoxin contamination.