Extractables and Leachables Risk Assessments for a large generics pharmaceutical company

Client

A large generics Pharmaceutical company

Background

The manufacture and use of pharmaceutical products can involve contact with various containers (including reaction vessels, tubes, filters and chromatography columns, and packaging such as glass bottles, needles, syringes etc) at various phases in their life cycle. During such contact, small amounts of the components of the processing and storage equipment may leach into the pharmaceutical product and subsequently be delivered to the patient along with the dose. The Pharmaceutical company needed to be confident that the patient will not be exposed to any such leaching chemicals in amounts that pose unacceptable health risks.

Project goals

Reassurance over the tolerability of the predicted doses can be provided by risk assessments from independent, expert toxicologists. Bibra employs a number of experienced, professionally-registered (RSB/BTS/ERT) toxicologists and was commissioned to provide hazard and risk assessment reports on a range of pharmaceutical products.

Approach

The client provided the relevant analytical reports. These recorded the laboratory efforts to detect and measure extractables (chemicals extracted from processing and storage equipment into classic simulating solvents) and leachables (chemicals extracted from equipment into the actual products).

The client described the exposure, which includes information on the dose per treatment, the dosing route (oral, iv etc), the frequency of treatment (e.g. daily, weekly), and its likely duration (single, a few weeks, lifetime etc).

Bibra then assessed the hazards (Inherent characteristics) of the individual chemicals to which patients might be exposed, and carried out risk assessments based on combining hazard data with information on likely dosage. Worst-case assumptions were made to address uncertainties. Where adequate toxicity data are lacking, it was often possible to make use of the Threshold of Toxicological Concern approach.

Project outcome

Bibra was able to provide independent, expert reports explaining why the anticipated exposures would not pose any significant health risks to patients. This allowed the client to pursue their proposed manufacturing and registration proposals with confidence that the health benefits of their products were not being undermined by inevitable low-level migration from packaging and processing contact materials.

Bibra project leader

Pete Watts

Pharmaceutical Product Toxicological Support

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