Elemental Testing in Medical Devices
By Exeter Analytical (UK) Ltd in Coventry
In the highly regulated and critical field of medical device manufacturing, the elemental composition of every component is paramount. From raw materials to finished implants and instruments, elemental testing is a non-negotiable step to ensure biocompatibility, prevent adverse patient reactions, and meet stringent global regulatory standards. Trust Exeter Analytical for elemental testing and analysis for medical devices, and contact us today.
CALL OUR TEAM ON 024 7632 3223 FOR A QUOTE
1994
EST.
Precision Purity for Patient Safety: The Imperative of Elemental Testing in Medical Devices
At Exeter Analytical, we specialise in comprehensive elemental analysis, employing robust analytical techniques to accurately detect and quantify trace elements, contaminants, and leachable substances. Our services are vital for:
Medical Device Manufacturers:
Ensuring raw material purity, monitoring manufacturing processes, and validating finished product safety and biocompatibility.
Regulatory Affairs & Quality Assurance Teams:
Demonstrating compliance with international standards and preparing for regulatory submissions (e.g., FDA, MDR).
Suppliers of Medical Grade Materials:
Verifying the elemental purity and consistency of polymers, metals, ceramics, and coatings.
Research & Development:
Investigating novel materials, understanding degradation pathways, and assessing potential interactions.
Failure Analysis & Troubleshooting:
Identifying the root cause of device malfunction or adverse patient events linked to elemental composition.
Why is Elemental Testing Crucial for Medical Devices?
Patient Safety & Biocompatibility (ISO 10993-18):
Identifying and quantifying potentially toxic or sensitising elements that could leach from the device into the body, causing inflammation, allergic reactions, or long-term systemic toxicity.
Regulatory Compliance:
Adhering to strict global regulations and pharmacopoeia guidelines (e.g USP <232>/<233> for elemental impurities) that set limits on certain elements.
Material Purity & Integrity:
Verifying the absence of impurities or contaminants introduced during sourcing, manufacturing, or sterilisation that could compromise device performance or safety.
Risk Management:
Quantifying heavy metals and other potential contaminants in soil, water, and mine tailings to assess environmental risks and develop mitigation strategies.
Quality Control & Consistency:
Ensuring that every batch of raw material and every finished device meets exact elemental specifications.
Forensic & Failure Analysis:
Investigating unexpected device degradation, corrosion, or patient complications by determining the elemental composition of affected areas.
CALL US TODAY ON 024 7632 3223 FOR A QUOTE
Our Elemental Testing Techniques for Medical Devices
At Exeter Analytical, we employ analytical techniques to deliver accurate and reliable elemental data tailored to your needs. Our laboratory is equipped to precisely identify and quantify a wide range of metallic and non-metallic elements present in various medical device materials, including polymers, metals, ceramics, and composites, as well as extracts from leachable studies. After appropriate sample preparation, we utilise a range of highly sensitive methods to achieve precise results.
.jpg)
Applications:
Trace Elemental Impurities: Detecting and quantifying critical elemental impurities, including heavy metals (e.g., Arsenic, Cadmium, Lead, Mercury, Chromium, Nickel) that are strictly regulated for medical devices.
Material Characterisation: Determining the full elemental profile of raw materials, coatings, and finished devices to confirm specifications and ensure consistency.
Leachables & Extractables Studies: Analysing extracts from devices to quantify elements that may leach out over time or under simulated physiological conditions.
Organic & Elemental Composition: As specialists in elemental analysis, we are uniquely positioned to determine the precise percentages of Carbon (C), Hydrogen (H), Nitrogen (N), and Sulphur (S). This fundamental analysis is vital for understanding the basic structure, purity, and thermal stability of polymers, bioabsorbable materials, and other organic components in medical devices.
Common Elements & Materials Analysed in Medical Devices
Our testing capabilities cover a broad spectrum of elements and material types critical to medical device safety and performance, including but not limited to:
Restricted Elemental Impurities (USP <232>/<233>, ISO 10993-18):
Arsenic (As), Cadmium (Cd), Lead (Pb), Mercury (Hg), Chromium (Cr), Nickel (Ni), Vanadium (V), Platinum (Pt), Palladium (Pd), Rhodium (Rh), Ruthenium (Ru), Iridium (Ir), Osmium (Os), Copper (Cu), Molybdenum (Mo), Silver (Ag), Gold (Au), Thallium (Tl), etc.
Alloying Elements (Metals):
Titanium (Ti), Cobalt (Co), Chromium (Cr), Molybdenum (Mo), Nickel (Ni), Iron (Fe), Aluminium (Al), Niobium (Nb), Tantalum (Ta), Zirconium (Zr) in surgical steels, titanium alloys, and cobalt-chromium alloys.
Polymer Components:
Carbon (C), Hydrogen (H), Nitrogen (N), Sulphur (S), Chlorine (Cl) – for basic composition and presence of halogenated additives.
Ceramic Components:
Silicon (Si), Aluminium (Al), Zirconium (Zr), Calcium (Ca), Phosphorus (P).
Trace Contaminants:
Elements from manufacturing processes, cleaning agents, or environmental exposure.
Materials:
Metals (stainless steel, titanium alloys, cobalt-chromium alloys), polymers (PEEK, PTFE, PVC, silicones), ceramics (zirconia, alumina), composites, coatings, and drug-device combination products.
Partner with Exeter Analytical for Trusted Medical Device Elemental Testing
When it comes to elemental testing for the medical device industry, precision, and reliability are paramount. Our laboratory, highly skilled chemists, and commitment to quality ensure that you receive accurate, actionable data every time.
​
Contact Exeter Analytical today to discuss your elemental testing needs.
024 7632 3223