How does Ä¢¹½tv's analytical chemistry testing support breakthrough insights for product and process challenges?
Whether you're assessing the biocompatibility of wearables, evaluating new types of materials or manufacturing processes for consumer electronics or medical devices, or trying to understand if an ingredient in a formulation has changed, Ä¢¹½tv's multidisciplinary teams help you understand real-world conditions that aren't captured by standard tests.
Extractables and Leachables Testing per ISO 10993-18
Ä¢¹½tv routinely performs extractables and leachables protocols for a variety of materials in accordance with ISO 10993-18 and Good Laboratory Practice (GLP) support as required. Simulated-use, exaggerated, and exhaustive extractions can be conducted on devices or components to identify the quantities of the isolable material present. The analytical data produced can support toxicological risk assessments on components of concern by one of our in-house toxicologists or can be provided directly to clients for their own analyses.
Purity and Contamination Assessment
Our staff has extensive experience conducting purity assessments of pharmaceutical compounds in compliance with compendial methods (United States Pharmacopeia, USP) via UHPLC under GLP as required. We also have capabilities for developing and validating non-compendial and other custom methods for challenging matrices.
Since contamination can occur on surfaces and in products across many industries, we are prepared to assist clients when downstream contamination issues arise — whether at the formulation level, in products such as cosmetics, adhesives, and lubricants, or at the system level, at bonded interfaces, in assembled devices, on printed circuit boards, and elsewhere.
Method Validation
Our experts have assisted clients with quality assurance (QA/QC) test method validation to ensure that SOPs are properly developed and implemented. In addition to on-site manufacturing audits, we can assist in the verification and implementation of existing methods, either during technology transfer matters or other instances where analytical method adaptations are needed.
Chromatographic Methods
Gas chromatography-mass spectrometry (GC/MS, TD-GC/MS, both liquid and vapor injection modes)
Ultra-high-performance liquid chromatography-QTOF mass spectrometry (UHPLC/MS, with tandem LC/MS/MS and photodiode array (PDA) detection capabilities)
Gel permeation chromatography (GPC) with refractive index (RI) and light scattering detectors (GPC-MALS)
Spectroscopy
Fourier-transform infrared (FTIR — transmission and ATR)
UV/Vis spectrophotometer
Access to Raman and other spectroscopic instrumentation
Microscopy
Optical microscopy
Optical profilometry
Scanning electron microscopy (SEM)
Focused ion beam/transmission electron microscopy (FIB-TEM)
Related Capabilities
Non-destructive 3-D X-ray computed tomography (microCT)
Water content: Karl Fischer (KF) titration
Glove boxes for reactive or air-sensitive chemistry
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017
Our Menlo Park Laboratory is recognized as an ISO 17025 accredited laboratory (). As applicable, the laboratory testing services are compliant with 21 CFR Part 58 and U.S. FDA Good Laboratory Practices (GLP), and the laboratory holds a DEA registration for Schedules I-V.Â
