Date of Award
Master of Science (MS)
Cooksey , Kay
Bix , Laura
Porous packaging materials, such as medical-grade paper and Tyvek¨, are used often by the medical device industry for packaging sterile devices when the products are sterilized post packaging. Their use can be attributed to the fact that multiple sterilization methods require the ability for vapors to enter and/or exit the package efficiently, while simultaneously reducing the amount of microbes entering the package. Much research as been done to study the effects of multiple material and environmental factors, such as material structure and dispersion concentration, on the microbial barrier properties of these materials, however no research had been conducted to examine the impact of relative humidity. This research was aimed at identifying the effect relative humidity levels can have on the microbial barriers of four porous packaging materials: coated and uncoated Tyvek¨ 1073B, dot coated Ovantex¨, and coated medical-grade paper. Research was conducted with slight adjustments to the ASTM F2638-07 test standard method for using aerosol filtration for measuring the performance of porous packaging materials as a surrogate
microbial barrier. The adjustments included preconditioning samples at 15%, 50%, and 90% relative humidity levels and switching samples after each tested flow rate. Results from testing show that the microbial barrier properties of medical-grade paper were significantly impacted by fluctuations in relative humidity. Microbial barrier properties of the medical-grade paper and Ovantex¨ were also significantly impacted by the dispersion flow rate through the material sample, while uncoated Tyvek¨ 1073B was found to only be slightly impacted. Interestingly, when analyzing the coated and uncoated Tyvek¨, a data analysis
suggests that the addition of the heat seal coating may significantly decrease the impact flow rate has on microbial penetration.
Blocher, Jennifer, "THE EFFECT OF RELATIVE HUMIDITY ON THE MICROBIAL BARRIER PROPERTIES OF POROUS PACKAGING MATERIALS USED IN THE MEDICAL DEVICE INDUSTRY" (2009). All Theses. 641.