Health risk assessment of extractables from a bulk vaccine container


A pharmaceutical product manufacturer


Extractables and headspace studies had been carried out on a container-closure system (polycarbonate bottles/HDPE caps) used to store a bulk vaccine product. The vaccine is administered by intranasal spray. Theoretically, in actual use, the detected extractables could become leachables and subsequently be inhaled by the patients. Bibra was asked for an independent, initial health risk assessment of the extractables. Any subsequent Leachables study could be used as the basis of a more definitive patient health risk assessment.

Project goals

To provide the client with a high-quality health risk assessment relating to possible inhalation of the extractables by patients.


Exposures to the extractables were estimated on a “worst-case” basis, making precautionary assumptions. On this occasion, the extractables were well-studied chemicals so the assessment relied heavily on the toxicity information and conclusions of recent expert group reports and REACH dossiers. Bibra also evaluated the possible impact on health if a mutagen were to be present as an extractable at close to, but below, the reporting limit. It was concluded with a high degree of confidence that the extractables would pose no significant risks to patients’ health, even if they became actual leachables at the same exposure levels.

Bibra project leader

Pete Watts

Pharmaceutical product toxicological support

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