Health risk assessment of aromatic hydrocarbon extractables

Background

The company had commissioned extractables studies on a stopper, used as part of the closure for the storage of a drug product for injection. Bibra was supplied with a laboratory analytical report describing the results of such studies on the test item.

Client

A pharmaceutical company in the far East.

Project goals

Bibra was asked for an independent health risk assessment, focusing on four “polycyclic aromatic hydrocarbons” (PAHs). The client advised on the duration and frequency of treatment.

Approach

The critical aspect of PAH toxicity is the potential to cause (genotoxic) carcinogenicity. As such, the assessment focused on this endpoint. One of the identified compounds was evaluated separately to the remainder since it was well-known to possess a distinct toxicological profile in comparison to the majority of PAHs.

Project outcome

Bibra’s health risk assessment report clearly illustrated that the various “PAH” substances would not pose any significant risks to patient health, even if they were to be genuine leachables.

Bibra project team

Daniel Threlfall

James Hopkins

 

Hazard and risk assessment More recent work Info about us Meet our team