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Film Characterization Of Single-Use BioProcess Containers To Determine Suitability For Specific Applications

Source: Thermo Fisher Scientific

The trend towards single-use containers and systems in the biopharmaceutical industry has led to a shift of concerns regarding cleaning and sterilization of conventional multi-use containers and systems to those regarding material characteristics and container/content interactions. The purpose of this document is to cover these concerns and explain our approach to them.

Flexible container systems consist of plastic films, ports, tubing, fittings and end treatments. Performance of a specific container system in a particular application depends on the material and manufacturing quality, as well as the conditions and constraints imposed by the application. The integrity of stored contents depends primarily on the characteristics of the film–the largest component (product contact surface area) of any flexible container system. 

A fleixible container system’s performance can help determine the suitability of that system for a specific application. The Aegis5-14 Film used in the Thermo Scientific's bioprocess containers have been tested for these 10 important characteristics for bioprocess applications:

1. Biological Compatibility
2. Tensile Properties
3. Puncture Resistance and Puncture Strength
4. Glass Transition Temperature
5. Transportability
6. Clarity
7. Permeability
8. pH Stability
9. Extractable Compounds
10. Cell Culture Growth Performance