The microbial barrier function of packaging for medical devices to be sterilized is an important aspect when selecting the right packaging material to ensure the safety of patients and medical staff. In accordance with ASTM F 1608, the effectiveness of this barrier is tested using the filter test to quantify the retention of airborne microorganisms.
Microbial barrier function according to ASTM F 1608 (filter test)
The filter test according to ASTM F 1608 is a standardized procedure that evaluates the performance of materials in the retention of microorganisms. This involves contaminating the material with a defined quantity of bacteria and then testing how many of these microorganisms can penetrate the material. The result is given once as a logarithmic reduction factor (LRF) and as a percentage value of the retention.
The results of the filter test are important for the selection of suitable packaging materials for medical devices and serve as proof of the effectiveness of the microbial barrier function. By complying with ASTM F 1608 standards, manufacturers can ensure that their products meet the highest quality and safety requirements.
Overall, the microbial barrier function plays an important role in healthcare to prevent infections and protect the health of patients. The filter test according to ASTM F 1608 is an indispensable tool for checking the effectiveness of this barrier and thus contributing to safety in the medical device industry.
Guidelines
- according to ASTM F 1608
For further information, please contact us at
verpackungspruefung@gfps.de