The Applied Technical Services Family of Companies (FoC) conducts extractable and leachable tests to identify and quantify the presence of harmful impurities in drug products.
What are Extractables and Leachables?
Extractables are chemical compounds or species that can be extracted from a container or packaging, contaminating the product. The contamination is likely to occur after the product and package interact under harsh conditions for extended periods of time. Leachables are organic and inorganic chemical compounds that can leach into drug products from their containers. Leachables are a subset of extractables, but unlike extractables, leachables can exist in normal conditions. They’re typically caused by inorganic materials such as additives and coatings.
About Our Extractables and Leachables Testing
Our ISO/IEC 17025:2017 accredited chemical testing lab contains the equipment needed to conduct highly accurate evaluations of various chemical compounds, including extractables and leachables. We can help our clients identify various sources of leachables, such as dyes, metals, and antioxidants. Our experts have decades of collective experience in chemical analysis, allowing us to provide thorough and accurate chemical testing services.
The Importance of Extractables and Leachables Testing
Drug manufacturers must abide by very strict regulations to ensure that their products are safe and effective for consumers. While many may assume that companies only test the chemical components of the drug, it is also important to evaluate the functionality of container systems. Our extractable and leachable testing services help our clients do the following:
- Identify potential impurities
- Comply with guidelines and regulations
- Maintain a product’s efficacy and overall effectiveness
- Increase consumer confidence in products
About the ATS FoC
The Applied Technical Services Family of Companies consists of an expansive network of companies that help industrial businesses evaluate and improve their products while remaining competitive in the marketplace. As an ISO 9001:2015 registered entity, we remain committed to fostering positive experiences for our clients by emphasizing quality and training as we continue to expand and improve our services. Please call +1 (888) 287-5227 or submit an online request for additional information regarding our extractables and leachables testing services.
