Characterization of adhesive related leachable deriving from medical infusion bag.

Background

供应商变更后, 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.

所面临的挑战

客户要求 im体育APP生命科学 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.

解决方案

Using HS-GC-MS (headspace 气体 chromatography-mass spectrometry) im体育APP’s 快速反应 团队，总部设在 曼彻斯特, confirmed the identity of the volatile organic substance to be Cyclohexanone, a precursor used in the production of solvent-based adhesives.

An 提取研究 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.

结果

im体育APP 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.