Biocompatibility evaluation of a series of autoinjector medical devices
Case study
The company manufactures a range of parts for use as components in a variety of medical devices.
Determining a suitable read-across surrogate for a pharmaceutical impurity
Case study
Following analytical studies on an intravenous drug product, an organic leachable from the container closure system (CCS) was detected, identified and quantified.
Evaluating the health risks posed by extractables and leachables from an ENDS device
Case study
In order to market their latest product in the United States, the client was intending to submit a Premarket Tobacco Product Application (PMTA) for a pod-based ENDS device.
Toxicological risk assessment of leachables from a syringe medical device
Case study
The company had commissioned leachables studies on a syringe medical device intended for flushing of intravenous catheters/tubing with saline. The leachables profile was examined at two time points (day 0 and about 2 months) and numerous substances were detected at low concentrations.
Evaluation of the endocrine-disrupting potential of a plant protection product
Case study
The Plant Protection Products Regulation (EC) No 1107/2009 is amended by Regulation (EU) 2018/605, requiring that information on the potential endocrine-disrupting properties of such products must be collated and evaluated. The European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) have published “Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009”, detailing the performance of such hazard identification, together with an Excel spreadsheet to be used as a template for gathering the necessary information on “human and animal health” and “non-target organisms”.
Hazard characterisation of several e-liquid ingredients
Case study
The client is required to provide regulatory authorities with up-to-date toxicological information related to the ingredients used in their products. Bibra were provided with a list of several substances and asked to produce a hazard review (considering the requirements of the European Tobacco Products Directive, TPD2) for each.
Literature Review Report in support of a plant protection product active substance regulatory submission
Case study
The approval or re-registration of pesticide active substances (Plant Protection Products) under Regulation (EC) No 1107/2009 Article 8(5) requires applicants to submit dossiers containing scientific peer-reviewed open literature on the active substance and its relevant metabolites and impurities, dealing with side-effects on human health, the environment and non-target species, published within ten years of the date of dossier submission.