Gas chromatographic–mass spectrometric analysis and subsequent quality improvement of plastic infusion packaging materials

• Opalescence of pharmaceutical primary packaging material was investigated.
• Cause of opalescence was studied using GC–MS.
• GC–MS results have shown the presence of 13-docosenamide which caused opalescence.

Although the opalescence of sterile transparent plastic materials utilized for the packaging of parenteral infusion drugs is a serious quality problem, most suppliers do not report the exact compositions of such polymers, and no literature data are available. Similarly, no information is available as concerns the potential incompatibility of the inner bag and the overpouch. Our gas chromatographic–mass spectrometric study revealed that the cause of the opalescence is the presence of a low-molecular-weight slip additive, 13-docosenamide (erucamide), which is transferred into the primary infusion bag from the overpouch during the heat-sterilization process. Autoclaving trials confirmed the analytical results. In view of these findings, a new slip additive-free overpouch has been produced as secondary packaging material, which does not give rise to opalescence.

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