Send Enquiry

 

There are so many medical devices manufactured and used around the world and they are required medical devices to be sterile, that is they have to be free of viable microorganisms. To make sure that the medical devices are free from microorganisms nation and international quality assurance systems have laid down the requirements of correct validation and control of sterilization processes and bio burden testing of medical devices.
 
 
To adopting the standards for minimizing the microbiological contamination of the medical devices prior to the sterilization, we can achieved by controlling the process, raw materials, and environment during the manufacturing. Even though taking care of the controlling the process it might be small numbers of microorganisms can be found on the medical devices before sterilization making them non-sterile.
 
Bioburden is the population of viable microorganisms on a product. D10 is the radiation dose required to kill 90% (1 Log) of a homogeneous microbial population. Dose is the calculated level of radiation absorbed by the product which are present on or in a product or a sterile barrier system. It is important isssue to understand the bio burden as it can be used in number of situations like –
 
Validation of Sterilization process
Compliments raw materials and packaging monitoring
Effectiveness of cleaning procedures measurement.
Monitoring of environmental issues.
Monitoring and control of manufacturing processes
 
Understanding of quanitfy and the nature of bio burden prior to sterilization as the kinetics of sterilization greatly differs between pure cultures and microorganism present on or inside devices. Sudden changes in the initial bio burden can cause failure off air otherwise validated and well controlled sterilization procedure.
 
IIRT-India are supporting the medical device industry with testing the bio burden of devices, components, raw materials.
 
IIRT-India is experienced  for the tesing of medical devices accordingly ISO standard 11737 part one (ISO 11737-1)
 
IIRT-India carried out numerous projects for developing the bio burden testing methods, validation for complex medical devices with multiple components. 
 
IIRT-India have expertise in validating the bio burden testing methods to ensure that the method is accurately estimating the bio burden of medical devices.
 
Please contact us  +91-9891649000/9711623080-90 or send us email at info@toxicityindia.org we promise you that our team will be happy to provide you a detailed proposal for burden testing of medical devices.