Our work
When patients receive treatment involving any pharmaceutical product or medical device, they can be exposed to small amounts of chemical substances known as "extractables and leachables" (E&L). These compounds can migrate from contact with pharmaceutical container closure systems (CCS), 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. Our approach to extractables and leachables risk assessment plays 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
Making sense of skin sensitisation
Blog articles
From cosmetics to cleaning products, skin allergy (sensitisation) is a prominent feature of our modern chemical-centric world. Put simply, this hazard is an abnormal reaction of the immune system which makes certain individuals overly sensitive to particular chemicals. Read more in our blog, to help you make sense of sensitisation.
Knowledge is key. Part 2: The bibra TRACE database (and supporting databank)
Blog articles
In Part 1, Peter Watts gave a potted history of his personal early experience in literature searching and toxicity data identification. Along with our colleagues of the same 'fine vintage', he weathered the storms of change, progressing from a time of back-strain (from carrying huge texts around) and index finger wear (turning pages) to dial-up and then to web-based searching. With your indulgence, Pete would now like to expand a little regarding TRACE and its value to clients and the bibra toxicologists.
Knowledge is key. Part 1: Toxicity literature searching, a personal history
Blog articles
Our Toxicology Director, Peter Watts, has written a very interesting article focussing on toxicity literature searching, from his own perspective (having been at bibra for 40+ years)
