Most medical devices manufactured and used around the world are required to be sterile, that is they have to be free of viable microorganisms. To ensure that the medical devices are free of microorganisms international quality systems have laid down the requirements for proper validation and control of sterilization processes and bio burden testing of medical devices.
The standards also call for minimizing the microbiological contamination of the medical devices prior to the sterilization, this is achieved by controlling the raw materials, process and environment during the manufacturing. Even after meticulously controlling the process small numbers of microorganisms can be found on the medical devices before sterilization making them non-sterile.
The term bio burden is used to describe this population of viable microorganisms which are present on or in a product or a sterile barrier system. It is very important to understand the bio burden as it can be used in number of situations like –
- Sterilization process Validation
- Monitoring of compliments raw materials and packaging
- Measuring the effectiveness of cleaning procedures
- Environmental monitoring
- Control and monitoring of manufacturing processes
It is very important to quantify and understand 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.
Our laboratory has been supporting the medical device industry with testing the bio burden of devices, components, raw materials as well as monitoring the manufacturing environment and measuring the efficiency of cleaning procedures to control bio burden of medical devices.
Our laboratory is experienced in applying the ISO standard 11737 part one (ISO 11737-1) Title Sterilization of Medical Devices – Microbiological Methods for determination of population of microorganisms on products.
We have carried out numerous projects for developing the bio burden testing methods for complex medical devices with multiple components. We also have expertise in validating the bio burden testing methods to ensure that the method is accurately estimating the bio burden of medical devices.
Please feel free to contact us using the contact form on the right or you can call us now on +91-8588851888 and our team will be happy to provide you a detailed proposal for burden testing of medical devices.