Health risk assessment of extractables – a vial used to store an ocular pharmaceutical

Client

A pharmaceutical company.

Background

The company had commissioned extractables and headspace analyses on a polyethylene vial intended for use as a container for a pharmaceutical product used to treat dry eyes.

Project Goals

Bibra toxicologists were asked to assess whether the extractables might pose any significant health risks to patients (in a short-term clinical trial) and subsequently to consumers (who might use the product on a daily basis for many years).

Approach

Bibra estimated exposures that might result from use of the product, and assessed whether these hypothetical exposures might pose any significant health risk to patients and consumers – assuming that the extractables might represent genuine leachables.

Project Outcome

The client was provided with a health risk assessment report, concluding that most of the extractables would not pose any significant health risks. Bibra identified two extractables for which a leachables study would be a better basis for a definitive health risk assessment.

Project Leader

Pete Watts

 

Medical devices

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