Our work
Patients undergoing treatment with any drug product or medical device can be exposed to small amounts of “leachable” chemicals. These can migrate from contact with processing equipment, packaging or delivery systems, and subsequently become part of the administered dose.
It is critical for all parties that such leaching does not occur at a level that presents a significant safety or quality issue. Extractables and leachables (chemical characterisation) studies play a critical role in this quality control and monitoring.
The E+L process
Extractables and Leachables Screening
Often, a comprehensive extractables and leachables study can return hundreds of compounds, all of which could be of potential health risk to a patient. We have developed a “screening” process where we can prioritise those substances that are more likely to result in a health risk. Compounds present at very low levels, or without inherent toxic hazards, can, with appropriate justification, be excluded from further more detailed and expensive toxicological risk assessment.
Toxicological Risk Assessment
Typically, our health risk assessments are based on E&L study results. The exposure, including details on treatment, would be described to us prior to starting our evaluation. We combine the hazard evaluation of the individual chemicals with exposure information to assess whether any significant health risks exist. Worst-case assumptions are made to address uncertainties. In cases of inadequate data, we use additional strategies such as read-across or a threshold of toxicological concern (TTC) approach. Where substance-specific hazard data are inadequate, read-across or a TTC approach may be introduced. Our risk assessors apply the applicable guidance from ICH or ISO, as well as guidelines developed and published by the Product Quality Research Institute (PQRI) and other expert groups.
Media/Expertise
Our team has been at the forefront of the E&L sector for many years. Pete Watts, one of our Toxicology Directors, along with Principal Toxicologist Chris Waine, is a regular presenter at E&L conferences. Chris is also an expert member of the BSI and ISO committees developing the 10993 series of standards for the biological evaluation of medical devices, including extractables and leachables testing and toxicological risk assessment.
Learn more about how our evaluation of extractables and leachables data can support your product development and meet regulatory guidelines - see case studies below, and please get in touch with us if you'd like further information.
Some of our case studies in this area
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.
