STERIS Announces New Extractables and Leachables Service Offering Featuring Advanced Chemical Analysis Laboratory

• Supports medical device and pharmaceutical manufacturing with additional testing and service capacity
• Provides a comprehensive suite of testing options for the validation of sterile medical devices and pharmaceuticals

As part of our long-term commitment to supporting medical device and pharmaceutical manufacturing, STERIS Applied Sterilization Technologies (AST) is pleased to announce the addition of Extractables and Leachables (E&L) testing, featuring advanced chemical analysis. The additional testing capabilities are performed in accordance with ISO 10993-18 for chemical characterization, ensuring comprehensive safety and compliance for medical devices and pharmaceuticals.

Our chemical analysis testing services includes:

• Extractables and leachables testing: Identification and quantification of potential leachable substances
• Cytotoxicity testing: Evaluation of medical device materials to ensure they do not release toxic substances that could inhibit cell growth or induce cell death upon contact with the human body
• Method development and validation: Development and validation of Customer-specific biocompatibility test methods for application
• TechTeam® technical professional guidance: Tailored guidance on biocompatibility test requirements specific to Customer product, ensuring compliance with industry standards
• Investigation of unexpected results: Support for chemical root cause analysis and countermeasure development to achieve desired results

Within these services, our chemical analysis testing includes a variety of analytical tests, including, but not limited to:

Test Type	Method/Technique
Elemental analysis	Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
Identification	Fourier Transform Infrared Spectroscopy (FTIR)
TOC analysis	Total Organic Carbon (TOC)
Microscopic evaluation / particulate analysis <USP 788>	Digital microscope
Melting point / glass transition	Differential Scanning Calorimetry (DSC)
Ion content	Ion Chromatography (IC)

In addition to these services, STERIS AST also offers wastewater analysis, supporting the safety and compliance of wastewater processing and recycling systems; testing performed in accordance with ISO 10304 and ISO 17294.

Our testing methods adhere to both USP (United States Pharmacopeia) and EP (European Pharmacopoeia) standards, ensuring that our services meet the highest international quality and regulatory requirements.

For more information about our new E&L service offering and advanced chemical analysis, please contact us.