Health risk assessment of contaminants originating from containers

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Client

A bio-pharmaceutical company.

Background

The company had detected large, opaque flakes within a number of products intended for intravenous administration. These flakes originated from the container closures. As well as the flakes themselves, additional product contamination was possible from two substances used as catalysts in the manufacture of the stoppers.

Project Goals

Bibra was asked to evaluate the toxicological risks posed to patients by the presence of potential contaminants arising from the flakes and from the stoppers.

Approach

The absence of specific characterization of the material potentially present in the flakes contaminating the drug formulations restricted the depth of the health risk assessment that could be undertaken by bibra. Searches were therefore of a general nature and captured broad evaluations of the relevant chemical group, the bibra TRACE database beings an unrivalled data-source for identifying suitable review documents. Subsequent searches for data on a number of specific, related materials were also undertaken. The other two possible contaminants were of a defined character and searches of TRACE, TOXNET and PubMed were based on their respective CAS RNs.

There were reassuring reports of a lack of adverse health effects in a sizeable number of people exposed to material similar to the flakes over a number of years. In addition, large safety margins were calculated between the anticipated patient exposures and the results of acute injection studies in laboratory animals. Comparison of exposures to the other two contaminants at their maximum potential concentrations with health criteria values (HCVs) established by expert groups indicated no health concerns.