Importance of Biocompatibility Testing in Medical Device Packaging

For packaging that contacts either the drug product or the human body (e.g., syringe plungers, IV bag ports), ISO 10993 standards mandate cytotoxicity, sensitization, and irritation tests. Advanced analytical tools such as GC‑MS and ICP‑MS detect trace leachables that could migrate into sensitive biologics. As regulatory scrutiny intensifies, packaging suppliers are establishing dedicated laboratories to perform these assays in‑house. Early‑stage biocompatibility screening reduces development timelines and prevents late‑stage failures during regulatory submissions.