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
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.
