Preventing Gas Ingress In Single-Layer Fluoropolymer Bags

By Joe Cintavey, Gore PharmBIO Products

The permeability of the films used in single-layer assemblies can result in oxygen and carbon dioxide ingress, which may impact the pH of a drug substance and affect its overall stability and efficacy.  While barrier films in bags can be useful for cold chain applications, they do not fully protect against gas ingress and ignore other sources of permeability, such as tubing. This is particularly true of smaller bags with larger surface-to-volume ratios (SA/V), which are frequently used for bespoke cell and gene therapies.

Barrier wraps that encompass the entirety of a bag system, including any tubing, connectors, can consistently mitigate concerning pH shifts. By combining the robustness of fluoropolymer bags in cold chain operations with the additional protection of a comprehensive barrier wrap, companies can minimize gas ingress to an extremely low level and better protect these sensitive, valuable therapeutics. Minimizing the potential for error when freezing and transporting these drugs is crucial to safeguarding patients, meeting stringent timelines, and avoiding the exorbitant costs associated with rework.