Characterization of adhesive related leachable deriving from medical infusion bag.

Background

Following a supplier change, the client detected a solvent-like odor deriving from the components of an infusion bag system. It was suspected that the adhesive used to attach the injection port to the IV bag may be the source of the odor and that there may potentially be an impact on product safety.

The Challenge

The client required Element Life Sciences to confirm the identity of the volatile component and provide an accurate estimate of the potential leachable levels that may enter the final drug product during storage in the IV bags.

The Solution

Using HS-GC-MS (headspace gas chromatography-mass spectrometry) Element’s Rapid Response team, based in Manchester, confirmed the identity of the volatile organic substance to be Cyclohexanone, a precursor used in the production of solvent-based adhesives.

An extraction study of the infusion bag port component provided quantitative evidence that the levels of Cyclohexanone present in the new component could potentially adversely impact patient safety.

In order to achieve the required reporting threshold (0.04µg/mL) it was necessary to optimize both the sample preparation methodology and the HS-GC-MS parameters.

The below chart shows mass spectra data for impurity and library database match.

The Result

Element confirmed that the change in manufacturer of the infusion bag did have an adverse impact on product safety. The results of our study allowed the client to source a suitable alternative before the product was released to market.