ISO 18562 evaluation of a medical device in contact with the breathing gas pathway
As part of a large programme of work in evaluating the safety of a new endotracheal tube device, bibra was asked to evaluate the health risks posed by exposure to potentially hazardous substances that may be transferred to the patient via the gas stream during device use.
N-Nitrosamines risk assessment for a pharmaceutical product
Bibra was asked to investigate two N-nitrosamines extracted from stoppers for vials used within the pharmaceutical sector.
PDE for a leachable in an intravenous pharmaceutical
ICH defines a Permitted Daily Exposure (PDE) as a pharmaceutically acceptable intake “protective of public health for all patient populations” and provides specific guidance on the derivation of PDEs for threshold toxins identified as residual solvents (Q3C guideline) and elemental impurities (Q3D guideline) in pharmaceuticals.
Derivation of a Tolerable Daily Intake (TDI) for a chemical in Food Contact Materials (FCMs)
Food-Contact Materials (FCMs) encompass all materials and articles that come into contact with food as it is produced, packaged, stored and consumed. Experts from the European Food Safety Authority (EFSA) have stated that the safety of FCMs must be evaluated to ensure that their potential transfer to foods would not have any adverse effects on consumers . Under EU regulation (EC) 1935/2004, FCMs must not transfer their components into the foods in unacceptable quantities.
Derivation of an intravenous PDE for a common leachable
Chemicals that leach into drug products from processing or manufacturing equipment, drug delivery systems and/or packaging may pose a health risk to patients.