AEON’s latest test campaign was to identify and quantify the degradation of PFA tubes on behalf of a Pharmaceutical Client. The impact of those findings resulted in increasing output and reducing downtime.
A world leader in the research, development, and manufacture of influenza vaccines approached AEON seeking assistance in developing a data model for the usable life of PFA (Perfluoro alkoxy Alkane fluoropolymer) tubes, which are used in their fill/finish production lines to transfer vaccine product into single use syringes.
The PFA tubes are currently replaced during periodic maintenance which requires production lines to be subject to downtime. Our client identified this downtime as a major contributor to their production capability, consequently AEON was asked to generate a test campaign that would identify key product performance indicators. With this information it would be possible to develop a mathematical model for the tube’s useable life span, and therefore allow our clients onsite engineers to validate the replacement interval and establish a baseline for condition monitoring.
Using AEON’s in house materials testing facility (CERES), we prescribed and performed a test campaign, comprising hundreds of discrete samples, to identify key indicators of changes in the parent material.
The following tests were performed:
- Inspection Testing at Varying Magnifications (x0, x7, x10, x200)
- Density Testing to ISO 1183
- Hardness Testing to ISO 868
- Tear Testing to ISO 34
- Tensile Testing to ISO 37
Example of PFA Tube under Test
With hundreds of samples and millions of discrete data points, we were able to define benchmark characteristics for brand-new tubes. Using this data, and working with on site engineers, we were able to validate their replacement intervals. The data model also permits for future optimisations of replacement intervals, directly benefitting production line availability and product throughput.
Using the data model, the on site engineers are now able to consider the implementation of condition monitoring (the process of monitoring the tube’s condition, in order to identify a significant change which may be indicative of a developing fault). Only by having the mathematical model of a tube’s life span is it possible to monitor those which are in-service.
The major value of this project is that the results allow our client to become more sustainable and reduce unnecessary waste, and with less time spent on maintenance they are able to increase manufacturing throughput whilst maintaining vaccine integrity.
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