Health risk assessment of leachables – a tubing used to transfer batch volumes of an anti-cancer pharmaceutical

Client

A pharmaceutical company.

Background

The company had commissioned extractables, leachables and headspace analyses on a silicone tubing used to transfer batch volumes of an anti-cancer pharmaceutical product.

Project Goals

Bibra toxicologists were asked to assess whether the extractables and leachables might pose any significant health risks to cancer patients.

Approach

Bibra estimated exposures that might result from use of the pharmaceutical, and assessed whether these exposures might pose any significant health risk to patients.

In the absence of any detected leachables, bibra made a “worst-case” assumption that an undetected leachable might be present at just below the limit of detection (LOD). This “hypothetical” leachable was assessed for both threshold (assuming a Cramer Class III structure) and non-threshold (assuming a mutagenic structure) health risk. TTC, ICH M7 and PQRI guidance were used. Even in this hypothetical situation, such a substance was shown not to pose significant health risk.

In addition, the extractables results were screened for any evidence of concern. Selected extractables (not identified as leachables) were assessed as if they were present at the leachables study LOD. Again, a reassuring conclusion was reached, this time on the basis of substance-specific toxicity data.

Project Outcome

The client was provided with a health risk assessment report concluding that the leachables and extractables would not pose any significant health risk. This provided good support for the conclusion that the tubing could be safely used to transfer batch volumes of the anti-cancer pharmaceutical.

Project Leader

Pete Watts

 

Extractables and Leachables

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