Pete Watts's case studies
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.
Registration of a novel biocidal active substance
Case study
EU manufacturers of biocidal products are required, under the Biocidal Products Regulation (BPR), to submit a dossier of information to the European Chemicals Agency (ECHA). Before a biocidal product can be registered, however, the active substance must also be approved by the Agency.
In silico prediction of genotoxicity and carcinogenicity
Case study
As part of their overall regulatory requirements, the client was asked to provide an assessment of the known or predicted genotoxicity and carcinogenicity of a number of ingredients in their products. Bibra were provided with a list of several substances and asked to carry out this work following the genetic toxicology in silico (GIST) protocol.
REACH registration of nearly 100 related metal compounds
Case study
Manufacturers of chemicals in, or importers into, the European Union are required under the REACH regulation to submit a dossier of information on their substances to ECHA.
Cosmetic Product Safety Report (CPSR) on a skin cream
Case study
Under Regulation (EC) 1223/2009, cosmetics within the European Union should not be placed on the market if they are harmful to health under normal or reasonably foreseeable conditions of use. Bibra was asked to produce a CPSR on a skin cream with multiple ingredients.
Biocompatibility review under ISO 18562 guidelines
Case study
The client commissioned bibra to review a biocompatibility report following feedback from US FDA.
Toxicological risk assessment of leachables from a combination product
Case study
The client was developing a ready-to-use (RTU) process for the administration of a viral-based product in a clinical setting. Bibra was requested to assist with the assessment of extractables during the development phase and leachables in the final RTU process - viral vector product.
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.
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.