Biocontamination Testing

Biological contamination is a serious problem for Class IIa, IIb and III Medical devices. It is the manufacturer's responsibility to ensure that medical devices are safe for patient health. In order to minimize the risk of contamination, everything used such as water, gas and lubricants, especially the control of air and surfaces, must be subject to strict control.

Microbiological changes can be detected with the data obtained within the scope of biocontamination tests, and the sterilization applied Validation and control of processes can be achieved, and the initial bioload can be compared with the end of the process.

While testing is done with a method using bioimpactants to determine air biocontamination, for surface biocontamination it can be performed with a swab or on an agar medium under standard conditions. Likewise, microorganism counts can be performed in process waters.

It is important to work with an expert team and competent laboratories in order to test and improve the quality and system performance of medical devices. As Nanolab Laboratories Group, we provide Biocontamination Testing services in Medical Devices.