Developing a Test Method to Determine the Maximum Allowable Leakage Limit of Microbial Ingress for Dialysis Films

Authors

Lexi Phillips, Utah State UniversityFollow

Files

Description

The purpose of this project is to design and develop a testing-apparatus and test-method to measure the maximum allowable leakage limit (MALL) for films used by Fresenius Medical Care (FMC). The MALL is the greatest leak size that does not pose a risk to the product. This is the first step in developing container closure integrity testing for sterile containers. This test is designed using guidance from USP 1207, a document detailing integrity assurance of packages holding sterile medical products, and 21 CFR 211. This test is focusing on microbial ingress rather than physical or chemical leakage. The test-method design is based on an aerosol microbial ingress test published in the PDA Journal of Pharmaceutical Science and Technology [1]. A few of the key variables considered are film, microbes, channel diameters, and pressure.

Publication Date

12-6-2022

City

Logan, UT

Keywords

dialysis films, integrity assurance, leakage limit, microbial ingress

Disciplines

Engineering

Recommended Citation

Phillips, Lexi, "Developing a Test Method to Determine the Maximum Allowable Leakage Limit of Microbial Ingress for Dialysis Films" (2022). Fall Student Research Symposium 2022. 61.
https://digitalcommons.usu.edu/fsrs2022/61