Brominated Flame Retardants (BFRs) Brominated Flame Retardants (BFRs), such as polybrominated diphenyl ethers (PBDEs) have become global environmental contaminants because of their widespread use in numerous household and commercial products.
Extractables and Leachables Testing
Extractables and leachables testing (E&Ls)
Extractables and leachables (E&Ls) are materials that migrate or leach unintentionally from various sources into a substance or material.
Such as, the migration of the chemical components from a pharmaceutical drug storage container into the drug overtime, or the medical tubing used to deliver medicine intravenously leaching into the drug itself, or plastic packaging into foodstuffs.
Materials that commonly leach include pharmaceutical containers, drug delivery systems such as tubing, manufacturing componentry, medical devices or implants and various forms of food packaging.
From these materials, there are several common leachables to consider, and which we test for, including:
- Bisphenol A (BPA)
- Dyes and colourants
- Lubricants, slip agents and emulsifiers
- Residual monomer, polymer, and oligomer species
- Phthalates, nitrosamines and polyaromatic hydrocarbons (PAHs)
- Antioxidants and stabilisers
- Anti-static coatings
- Toxic elements such as arsenic, cadmium, chromium, lead, thallium, and mercury
Extractables and leachables (E&L) testing can be done for pharmaceutical companies, medical device companies and also for food packaging. The testing ensures that no unwanted chemicals migrate from the packaging or device into the product they contain.
Leeder Analytical is a specialist laboratory based in Melbourne, Australia servicing both government and private enterprise clients with over 20 years of experience in extractables and leachables testing, analysis, and reporting.
Leeder Analytical’s founder and principal scientist, Dr John Leeder’s PhD was in the this specific area, for the examination of E&Ls from intravenous (IV) bags and medical devices.
Our qualified team of laboratory technicians employ a wide range of testing methodologies within our world class, purpose-built laboratory.
Our extractables and leachables testing will assist with:
- The discovery and profiling of extractable materials (inorganic and organic)
- Sequential extractions as well as using techniques to isolate extractable in a wide array of conditions
- The characterisation of leachable materials by chromatographic and spectroscopic investigations
- Determination of the Analytical Estimation Threshold (AET)
- Rigorous testing including accelerated degradation testing
- Calculations of the qualification threshold based on Safety Concern Thresholds (SCTs) for identified extractables
- Method development and validation of potential leachables across pharmaceutical products, as well as food and beverages.
The importance of testing for extractables and leachables
For organisations to comply and be in alignment with Federal and State Departments of Agriculture, Water and Environment, as well the Australian Therapeutic Goods Administration it is often required they have a detailed leachables and extractables report for their products and packaging.
It’s critically important that testing for extractable and leachables are done not only to ensure safe consumption of pharmaceutical products or food and beverages but to also validate materials purity in a wide range of manufacturing processes.
Extractables and Leachables tests are done to determine the possibility and the rate of leachability in controlled storage conditions and advanced degradation circumstances such as in the presence of moisture and/or heat.
The team at Leeder Analytical conducts extractables and leachables tests in our NATA accredited laboratory utilising world-class instruments capable of detecting ultra-trace levels of leachables and extractables.
Who we work with?
Our NATA accredited laboratory conducts extractables and leachables testing for environmental engineers, scientists, consultants, pharmaceutical manufacturers, and regulators (EPA) as well as developers and government bodies.
These professional and government organisations choose to work with Leeder Analytical because we offer reliable and accurate testing, as well as extract key insights from the scientific findings.
They choose Leeder Analytical because they’re able to trust in the speed, effectiveness and efficiency of our processes, and importantly the accuracy of our results and interpretations.
Methods of Extractables and Leachables Testing
Leeder Analytical is able to develop/modify and validate methods to demonstrate the analytical procedure is suitable for its intended use.
We are able to demonstrate the methods accuracy, precision, specificity, limits of detection and quantitation, linearity and range, robustness and the uncertainty of the method.
Some of the analytical techniques and instruments we use to test and analyse extractables and leachables include:
- GC with a wide range of detectors including FID, ECD, TCD, FPD, NPD
- LC with a wide range of detectors including UV, DA, RI, Electrochemical, Conductivity
- Ion Chromatography
- Sample extraction and Preparation
- Gallery Analyser