An accelerated aging study on a syringe – health risk assessment of leachables
A multi-national medical devices manufacturer.
The company had commissioned an accelerated stability (aging) study on syringes intended for flushing of intravenous catheters/tubing with saline. The leachables profile was examined after about 70 days at 60°C, conditions used to mimic normal storage for around 3 years. A small number of organic leachables were detected.
Bibra was asked to assess the possible health risks to patients. The client advised on syringe use rate (number/day) and length of treatment.
Bibra estimated “worst-case” exposures and assessed whether these leachables might pose any significant health risk to patients. Expert Group reviews and opinions, REACH dossiers and the primary literature all made contributions to the health risk assessment. 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.
Bibra’s health risk assessment report clearly illustrated that the leachables would not pose any significant risks to patient health.
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