Particulate Contamination Levels In Single-Use Systems

With the growing adoption of single-use systems (SUS) products more scrutiny has been given to the purity concerns of single-use components and their potential impact on biomanufacturing, storage, and transportation of high value final products.

Entegris collaborated with Precision Nanosystems, Inc. (PNI)⁵ to perform a study using model mRNA-encapsulated lipid nanoparticles (LNPs) to investigate material adsorption of mRNA-encapsulated LNP over seven-day storage time comparing the Aramus fluoropolymer bag to commonly used glass vials and polypropylene (PP) cryotubes.

Aramus™ single-use bag assemblies are made of a single-layer, high-grade, gamma-stable fluoropolymer and provide high purity, extremely low extractable and leachable (E&I) profile, exceptional chemical compatibility, and increased safety for critical process fluids and final products. Specific attention is paid to minimize particulate contamination through ISO Class 5 cleanroom manufacturing and quality control (QC) testing for contamination with the AccuSizer® liquid particle counter.

This study suggests that Aramus fluoropolymer bag assemblies are much cleaner than bags from competitors and consistently meet the USP<788> standard, while competitors’ cryobags sometimes do not meet the standard.