A human health risk assessment of API-related impurities
Case study
Whilst developing an inhalation spray drug product, the client identified two impurities with chemical structures related to the Active Pharmaceutical Ingredient (API). Click through to read more about how we dealt with this interesting project.
Human health risk assessment of unknown contamination
Case study
The client reported that small “brown spots” had been observed on the inside surface of a batch of aluminium tubes that contain a topical drug product. The source and chemical composition of the brown spots was unknown. Click through to read more about how we dealt with this interesting project.
Toxicological risk assessment of a disinfecting agent in a syringe medical device
Case study
The client manufactures a product which is used as part of a syringe line medical device. The connection set-up has the potential to introduce a disinfectant chemical into the line and be injected into patients. Click through to read more about how we dealt with this interesting project.
Literature monitoring and hazard characterisation for food supplements
Case study
The client was interested in the potential adverse and beneficial effects of a number of ingredients found in food supplements and other ingested consumer products. In addition to the assessment of some defined chemical substances, the ingredients under investigation included several plant and mushroom extracts along with their key constituents.
Non-clinical overview
Case study
Following the reformulation of an emollient, an increased level of an impurity was detected compared with the previous formulation. Based on this, the client proposed a new shelf-life specification limit for the impurity. Click through to read more about how we dealt with this interesting project.
A human health risk assessment of detected extractables
Case study
The client produces a foam-based drug product that patients can self-administer from an aerosol cannister. According to the manufacturer of the container-closure-system (CCS), several compounds (including some unknown constituents) were identified as extractables from two components of the cannister that directly contact the drug product.
Determining a Specific Migration Limit (SML) for a data-deficient compound identified in food labels
Case study
The client was informed by a supplier that a chemical compound with a worrying structure was present within a food label ink. Click to find out how we dealt with it.
Pod-based ENDS device PMTA assessments
Case study
As part of a Premarket Tobacco Product Application (PMTA) for a pod-based ENDS device, bibra was asked to provide support preparing non-clinical and human health impact assessments.
ISO 18562 evaluation of a medical device in contact with the breathing gas pathway
Case study
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.
Health risk assessments relating to the excipient components of the Voke® formulation
Case study
A novel nicotine replacement device was designed to deliver a pressurised nicotine formulation via a breath operated valve in a cigarette sized medical device. Kind Consumer received a Marketing Authorisation for its lead product, Voke®, in September 2014.