Medical Lab Testing: TGA – Thermogravimetric Analysis
TGA – Thermogravimetric Analysis measures weight changes in a material as it is heated in a controlled atmosphere. The test identifies moisture loss, volatile components, polymer decomposition, and inorganic residue through distinct weight loss steps. For medical manufacturers, TGA is essential to verify material composition, filler content, thermal stability, and purity in polymers, composites, and coatings used for implants, tubing, and device components.
Accurate compositional data from TGA helps ensure medical polymers meet strict purity and stability requirements. Variations in filler or residue can affect mechanical properties, biocompatibility, or processing behavior. Applus+ Reliable Analysis already maintains accredited TGA capabilities alongside our DSC, melt flow, and polymer characterization programs, providing a comprehensive thermal analysis toolkit.
These evaluations support material qualification under ISO 10993 and USP standards. Manufacturers use TGA data to confirm supplier specifications, monitor batch consistency, and document thermal decomposition profiles for regulatory submissions. Applus+ Reliable Analysis delivers clear, well-interpreted thermograms using equipment already operating daily under our ISO/IEC 17025 accreditation.
Common Thermogravimetric Analysis Medical Testing Standards:
ASTM E1131 Compositional Analysis by Thermogravimetry
ASTM E1131 uses thermogravimetric analysis (TGA) to determine the composition of materials by measuring weight loss as a function of temperature in a controlled atmosphere. The test identifies moisture, volatile components, polymer decomposition, and inorganic residue (ash) through distinct weight loss steps. Medical manufacturers use TGA to verify filler content, purity, and thermal decomposition profiles in polymers, composites, and coatings used for implants, tubing, and device components.
ISO 11358-1 Plastics General Principles
ISO 11358-1 outlines the general principles of thermogravimetry for polymers, defining test conditions, atmosphere control, and interpretation of weight loss curves for compositional analysis. The standard ensures consistent and comparable results across different laboratories. It is essential for medical-grade polymers to characterize thermal stability, filler content, and decomposition behavior in tubing, films, and molded medical devices.
USP <891> Thermal Analysis (TGA component)
USP <891> describes thermal analysis techniques, including thermogravimetric analysis (TGA), for evaluating materials used in pharmaceutical and medical applications. The chapter provides guidance on instrument operation and interpretation of weight loss curves for moisture, volatiles, and decomposition. It is commonly applied to medical plastics, packaging, and components to ensure thermal stability and low residue levels in drug-contact or sterile products.
ASTM E2402 Mass Loss and Residue Measurement Validation
ASTM E2402 provides a method for validating the mass loss and residue measurement accuracy of thermogravimetric analyzers using reference materials. The standard ensures the TGA instrument performs within acceptable limits for quantitative analysis. It is important for medical polymer testing to guarantee reliable compositional data and compliance with quality system requirements for material characterization.
Your Partner for Expert Thermogravimetric Analysis Testing
Applus+ Reliable Analysis stands ready to support your medical polymer and material TGA thermogravimetric analysis needs. Our ISO/IEC 17025 accredited laboratory already maintains the necessary thermogravimetric analyzers and supporting thermal capabilities, allowing us to efficiently add these medical standards with only minor validation and training.
Whether you are qualifying new tubing and films, validating composites or coatings, or ensuring material purity, our team provides accurate and reliable data backed by decades of materials testing expertise. We invite you to Contact us to discuss how our expanded medical testing capabilities can support your next project or regulatory submission.
Additional Applus+ Reliable Analysis’ Commercial Medical Testing Capabilities
Whether it be material EMC, environmental, fabrication, or durability testing, Applus+ Reliable Analysis has a full lab of test equipment, which permits us to provide short lead times on scheduling. Our team strives to give our customers more time and energy on product development rather than testing.
Below is a list of common medical testing types that Reliable Analysis offers. Don’t see what you are looking for? Contact us, and we will determine the best course of action.
