Intertek is the industry leader with over 42,000 people in 1,000 locations in over 100 countries. Whether your business is local or global, we can ensure your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world.
Biomaterial analysis and testing services supporting development and market approval for medical devices or drug device combinations
Biomaterials are materials of natural origin or made synthetically which can be implanted to replace or repair missing tissue. There is an emphasis on testing services for biomaterials and biopolymers which has increased in demand as they have found increasing application within healthcare technology, such as regenerative dentistry, bone graft, tissue scaffolds, wound care, implantable devices and cosmetic surgery.
To ensure safe and effective biomaterial products, and to meet the regulatory requirements of marketing authorisation, robust laboratory testing is required in order to understand aspects related to product safety, such as their tendency for releasing leachable substances, or performance criteria, such as mechanical properties.
Our biomaterials scientists draw upon a wide range of analytical capabilities in order to understand the identity, purity, and biosafety of a growing number of biomaterials utilised in healthcare products through physical, chemical, mechanical, and microbiological testing methodologies. We also help manufacturers assess the safety of finished devices with supporting toxicological consulting. We provide analytical programs to support product development and also routine QC of raw materials or finished products.
We have experience with many types of materials used such as liquids, gels, polymers, metals, ceramics, hydroxyapatite, composites, or biologically sourced material such as collagen, chitosan, peptide matrices, and alginates.
Pore size, pore geometry and pore size distribution, interconnectivity, and porosity are all important to the function of the biomaterial and impact the surface properties which in turn impacts interactions with cells. Recently, novel methods of processing have also given rise to materials with controlled physical properties, for example, porosity. We utilise light microscopy, scanning electron microscopy (SEM), surface areas determination by BET to characterise these properties. We can also apply X-Ray diffraction (XRD) techniques to study the degree of crystallinity and phase types in materials for example HA-type materials.
Biomaterials will be subject to various stress-strain conditions when in use. Our teams can help you to explore the performance of your biomaterials through stress-strain and failure flex fatigue testing over time. We can also provide viscoelastic (dynamic mechanical) properties and studies to monitor the decay of properties during degradation.
Our teams provide identification and quantification of the biomaterial chemical constituents for use in the screening of potential new materials, to achieve a comprehensive understanding of the product for regulatory submission documents or for the identification or quantification of contaminants or degradation products.
Our laboratories are equipped with a wide range of techniques to determine chemical composition. We use infrared spectroscopy (FTIR, ATR-FTIR) analysis, nuclear magnetic resonance (NMR), size exclusion chromatography (SEC) and inductively-coupled plasma spectroscopy (ICP) to achieve an estimate of the identity and gross composition (and trace elements).
Elemental information about the biomaterial surface via SEM coupled with EDX, and for bulk materials by ICP, can also highlight the presence of potentially toxic metals such as lead, mercury, cadmium and arsenic.
There is a rapidly growing interest in the processing of biomaterials to incorporate actives such as antibiotics, antimicrobials, synthetic polymers and inorganic species (perhaps as an X-ray imaging agent) as developers discover new applications. Our scientists design robust analytical studies to define the controlled release of these active molecules from the biomaterials.
For biomaterial polymers, our experts can not only characterise the bulk polymer material but can also determine the additive species such as plasticizers, colorants, anti-oxidants and fillers and impurities such as unreacted monomers and oligomers.
Our teams can conduct controlled studies to identify and quantify extractable and leachable substances that arise from biomaterials of various types. Our toxicology team utilizes data from such studies to perform assessments to evaluate the level of risk that is associated with exposure to potential leachables from biomaterials under their intended conditions of use. This allows our customers to determine whether their products may be exposing patients to unwanted or harmful substances and to take appropriate actions to resolve these issues before they become a safety hazard.