Health risk assessments of extractables profiles allowed a client to make a safety-based choice between syringe types

Client

A multi-national medical devices manufacturer.

Background

The company had commissioned extractables analyses on three different types of syringe intended for flushing of intravenous catheters/tubing with saline. A number of organic and inorganic extractables were detected.

Project goals

Bibra was asked to assess the possible health impact if the syringe extractables were leachables in practice. The bibra evaluation also allowed the client to select a preferred syringe type, based on potential leachable-associated health risk.

Approach

Bibra estimated “worst-case” exposures that might result from use of the three syringes, and assessed whether these hypothetical exposures might pose any significant health risk to patients – assuming that the extractables might represent genuine leachables. Expert Group reviews and opinions, REACH dossiers and the primary literature all made contributions to the health risk assessment, and these were supported by “read-across” and (Q)SAR analyses. For chemically unidentified extractables, worst-case assumptions on structure were made (i.e. they were assumed to be Cramer III compounds and to contain a structural alert for mutagenicity), and the assessor applied the Threshold of Toxicological Concern (TTC) concept. ICH M7 guidance was also used because the anticipated syringe use was intermittent and less-than lifetime.

Project outcome

Bibra provided the client with health risk assessment reports on the three syringe extractable profiles, each clearly showing that that the organic and inorganic extractables would not pose any significant health risks to patients.

In addition, the syringes showed very different extractables profiles, allowing the client to identify the “cleanest” syringe profile.

Bibra project team

Daniel Threlfall

Pete Watts

 

Extractables and Leachables

More recent work Info about us Meet our team