Biomaterial testing expertise supporting development and market approval of tissue scaffold, cosmetic products, wound care, implantable medical devices or drug delivery systems.

Biomaterials testing is crucial for evaluating materials used in cosmetics, medical devices, and therapies to ensure safety, efficacy, and regulatory compliance. They can be materials of natural origin or made synthetically which can be implanted to replace or repair missing tissue. These have applications in drug delivery or combination products, such as regenerative medicine, regenerative dentistry, joint replacements, bone graft, tissue scaffolds, wound careimplantable devices and also in cosmetic surgery. For medical devices, especially those implanted in the body, extensive testing is required to assess mechanical properties, degradation behavior, and biocompatibility. Materials must withstand sterilization processes without degrading and must not cause adverse reactions in the body. In drug delivery, biomaterials are tested for their ability to encapsulate and release therapeutic agents effectively. Testing focuses on release and stability in various physiological conditions, and the interaction between the material and the drug.

To support development, biomaterials testing data from chemical analysis provide insight into the material’s characteristics and how these are impacted by production processes, microstructure, and chemistry. Understanding structural, surface, physical, and mechanical properties is important as they affect device performance, stability, and safety. To ensure safe and effective biomaterial products and meet regulatory requirements for marketing authorization, robust laboratory testing is required to assess aspects related to product safety, such as their tendency to release leachable substances, or performance criteria, such as mechanical properties.

Biomaterials Analysis Expertise
Our biomaterials scientists draw upon a wide range of analytical capabilities to understand the identity, purity, and biosafety of a growing number of biomaterials used in healthcare products through physical, chemical, mechanical, and microbiological testing methodologies. We have experience with many types of materials used such as liquids, gels, polymers, metals, ceramics, hydroxyapatite, composites, or biomaterials such as collagenhyaluronic acidchitosan, peptide matrices, and alginates.

We also help manufacturers assess the safety of finished devices with supporting toxicological consulting. We provide analytical programs to support product development and routine quality control (QC) of raw materials or finished products. Pore size, pore geometry and size distribution, interconnectivity, and porosity are all important to the function of the biomaterial and affect surface properties, which in turn impact interactions with cells. Recently, novel processing methods have also given rise to materials with controlled physical properties, such as porosity. Our scientists utilize light microscopy, scanning electron microscopy (SEM), and surface area determination by BET to characterize these properties. We also apply X-ray diffraction (XRD) techniques to study the degree of crystallinity and phase types in materials, such as hydroxyapatite (HA) types.

Bringing quality and safety to life, we offer Total Quality Assurance expertise for biomaterials testing to help you to make sure that materials meet safety and performance standards, minimizing risks to patients and consumers while maximizing the therapeutic and functional benefits of the final products. 

Biomaterials Analysis Services Include

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.

Related Links

Biopolymer Characterisation

Biopolymers are finding application in regenerative medicine, drug delivery, wound care, cosmetics and as food additives.

Download our conference presentation to find out more.

Intertek Pharmaceutical Services Manchester
P.O. Box 42
Hexagon Tower
Blackley
Manchester, M9 8ZS
United Kingdom

For location use: M9 8GQ

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