chemical characterization medical device


The Service Leader in Life Science Testing. Terms and Conditions | Eurofins Global, In Vitro Alternatives for Biocompatibility, In Vitro Testing as an Alternative to In Vivo Biocompatibility Testing, Metallurgical Engineering & Characterization, Chemical Characterization of Materials (ISO 10993-12, 18, 19), Identification and Quantification of Degradation Products (ISO 10993-13, 14, 15), Determination of Tolerable Intake for Extractable Substances (ISO 10993-17), Ethylene Oxide Sterilization Residuals (ISO 10993-7), Characterize the degradation and dissolution of resorbable polymer devices or bone ingrowth coatings, Ensure the safety profiles of processing aids or additives used in plastic devices, Assess the impacts of changes to raw material suppliers, processing techniques or sterilization methods, Ensure products are free of processing contaminants and residuals, such as machining oils and cutting fluids. To that end, NAMSA will release its opinion on specific topics of concern discussed by the FDA in the future. With todays devices that include polymers and plastics, LC-MS is an analytical method that tends to yield more chemicals what means the laboratories must tap into their experts to make the identification; a significant resource commitment. These Others might see it as an important way to reduce risk or liability. We can then examine these potential toxicities, as well as the in vivo testing data, and better assess overall biocompatibility. TurbidityThis method is designed to measure the turbidity by comparing the intensity of light scattered by an aqueous sample with the intensity of light scattered by a standard reference suspension under the same conditions. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers' operations and supply chains. The impact on the biocompatibility from these changes must be evaluated as described in ISO 10993 part 1. Abstract During the formulation and manufacturing of polymeric materials for medical devices, the materials go through multiple stages and undergo many transformations. Multiple analytical techniques aid in uncovering the full range of extracted chemicals associated with your product. Purified Water, USPUSP requirements for purified water include water conductivity and total organic carbon. Physiochemical Tests PlasticsThese tests, designed to determine the physical and chemical properties of plastics and their extracts, are based on the aqueous extraction of the polymer. Contact Us| Medical devices are often composed of a variety of chemistries, materials and components including as examples metals, polymers, electronic components, critical surface chemistries, etc. Because of the difficulties of retrospective analysis, this information is best obtained from the supplier or manufacturer of the material [emphasis mine]. Once the device composition is established, an assessment should be made to determine if residual risk remains. You can obtain detailed information about the use of cookies on our website by clicking on "More information. Exposure to low level chemistries in medical devices can pose a safety risk to patients. For instance, ISO 10993-13, section 5.2 (regarding polymeric materials) states: The initial material characterization shall address the bulk polymer and the residuals and additives present in the final device. pHThe pH value represents the acidity or alkalinity of an aqueous solution or suspension. Identification of compounds is extremely important for a toxicologist to accurately assess risk. Evaluation of biological safety of devices is experiencing some of the most significant changes in history. As ISO 10993 allows for existing safety data to be used instead for further testing when appropriate, it may be more efficient to use established materials if possible. Calcium ResidualThis method is used to determine the residual calcium of demineralized bone and other tissue-based products. By analyzing the device components, and by looking at the types and amounts of chemicals that may migrate from a device to a patient during use, potential toxicities can be predicted. | +1 (833) 888-0224 | Headquarters at 200 Gilbert Street, Mansfield, MA 02048. This method of testing produces data that has been shown to correlate strongly with human biocompatibility. Fourier Transform Infrared (FTIR) ScanThis test is a type of infrared spectroscopy in which the sample is subjected to all the wavelengths in the region of interest at all times, instead of only a small portion at a time. Once the chemistries are identified, a toxicologist can perform a toxicological risk assessment to evaluate safety. ChlorideOne of the major inorganic anions found in the environment, the chloride ion, in the form of a salt, is an integral component of many isotonic and physiological solutions. Biocompatibility is often used in relation to the biological safety evaluation The changes could be due to a manufacturing site change, sterilization process change, process aid change, etc. NAMSA invites you to access the full publication by clicking here: Chemical Characterization and Non-targeted Analysis of Medical Device Extracts: A Review of Current Approaches, Gaps, and Emerging Practices. Protein AssayThe modified version of the classic Lowry protein assay is used to determine the amount of saline-extractable protein associated with products made from natural rubber (e.g., latex gloves). While identification using some analytical methods is relatively straight-forward, identification of compounds from LC-MS can be challenging, as no commercial databases exist. USP Chemistry TestsTesting is based on each individual USP monograph. Our services include: Extractables and Leachables for Medical Devices. Physicochemical Tests, USP Test Panel Elastomeric Closures for Injections <381>This series of tests is designed to provide information about the physical and chemical characteristics of elastomeric (rubber) closures. EAG has expertise in extractables and leachables studies for pharmaceuticals, medical devices and consumer products. Standards for evaluating the biocompatibility of medical devices have been in effect for over ten years, yet recent FDA guidance emphasizes the importance of chemical characterization of materials. The developers of medical devices evaluate the biocompatibility of their device prior to the FDAs review and subsequent introduction to the market. We have years of experience evaluating polymers, metals, alloys and ceramics for device applications. UV/VIS SpectrophotometryThis refers to absorption spectroscopy or reflectance spectroscopy in the ultraviolet-visible spectral region or light in the visible and adjacent ranges. Our scientists can help you move efficiently through the FDA approval process, providing robust data for toxicological evaluations. Additionally, chemical characterization can be used to determine whether modifications to the materials and manufacturing processes alter the chemistry of a patient-contacting device to an extent that could impact device safety. Chemical characterization, described in ISO 10993-18:2020, can generate information for toxicological risk assessment and is an alternative approach for addressing some biocompatibility end points (e.g., systemic toxicity, genotoxicity, carcinogenicity, reproductive/ developmental toxicity) that can reduce the time and cost of testing and the need for animal testing. An important step in the process is that of characterizing the material and identification of chemicals that can migrate or extract from the polymer components. This chemical characterization testing evaluates how much and how quickly compounds can be transferred from the device into the environment. The absorption or reflectance in the visible range directly affects the perceived color of the chemicals involved. Sometimes these tests require significant sample preparation to ensure the chemical characterization testing environment is suitable to represent the use condition. In recent years, medical device manufacturers have faced rapidly evolving expectations about conducting biocompatibility testing to support preclinical product safety testing. On February 17, 2022, the American Chemical Society released a publication on behalf of the U.S. Food and Drug Administration (FDA) describing the current state and opinion of the FDA regarding chemical characterization processes and ways in which to improve them.

biomaterials are evaluated to determine if the produce an unwanted FlashpointFlashpoint is used to determine the temperature at which a liquid or volatile solid gives off vapor sufficient to form an ignitable mixture with the air just above the surface of the sample within the test vessel. We strive to offer the most effective business practices while employing a staff of technical experts. devices or other devices that may come into contact with the body. The first step to evaluating potential risk is to identify the chemistries extracted under aggressive conditions. This can include colorants, plasticizers, specific metals, and ceramics, for example. ISO 10993-18 offers a five-step process for evaluating the biological safety of medical devices: Materials characterization is needed in steps 1-3 and EAG offers complete suite of services. This can be evaluated through a comprehensive chemical comparative study to investigate the extractable profiles and/or surface chemistries. Whether your business is local or global, we can help to ensure that your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world. Residue on IgnitionThis test determines the total mineral content of a sample or extract when ignited to 800C in a muffle furnace. Water for Injection, USPUSP requirements for water for injection include water conductivity and total organic carbon.

ISO 10993 regulations include the requirements for chemical testing of medical devices to demonstrate the possible migration and identification of the migrating species. body. To find out more, please see our privacy policy. Our team of chemists and toxicologists will meet with customers to develop an appropriate test plan that aligns with current regulatory expectations. Our animal science operations are accredited by AAALAC. Learn More, Validating the specifications, value and safety of your raw materials, products and assets. All rights reserved. At PBL we hear a lot of questions from medical device clients regarding FDA material and chemical characterization requirements. Moisture ResidualThis is a gravimetric method for determination of water. In fact, the ISO 10993 standards, a series of standards on methods to be used to determine the biocompatibility of devices, recommend that as much data as possible be gathered from material manufacturers. Copyright 2022 Rodman Media. During the design of chemical characterization studies, NAMSA strives to recommend the most scientifically-supported approaches. | Sitemap, Quadrupole Time of Flight Gas Chromatography Mass Spectrometry, Quadrupole Time of Flight Liquid Chromatography Mass Spectrometry, Inductively Coupled Plasma Mass Spectrometry, Laser Light Scattering Particle Size Analysis, High Temperature Gel Permeation Chromatography, Gel Permeation Chromatography Standardized, Gel Permeation Chromatography Tetra Detection, Inductively Coupled Plasma Optical Emission Spectrometry, Chemical Characterization Testing of Medical Devices, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and, Biological Endpoint Testing in Biocompatibility Evaluations, An Overview of Toxicological Risk Assessments, The Role of Chemical Characterization Testing within a Biological Evaluation Process, How to Develop a Biological Evaluation Plan. Total SolidsTotal solids is the term applied to the material residue left in a vessel after evaporation of the sample and its subsequent drying in an oven at a specified temperature, usually between 103C and 105C. jarret polymer nanocharacterization analytical We hope to see working groups, on hiatus for the last two years, meet with renewed vigor and express perspectives not yet considered. In recent years there has been a great deal of discussion of the merits of chemical and material characterization. This Perspective is outlined according to the steps of an extractables study: information gathering, extraction, extract sample processing, system selection, qualification, quantification, and identification. Learn More, Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards. Design of Robust and Sensitive Extractables and Leachables StudiesExtractables and Leachables Applications: Studies on Process Materials and Container Closure SystemsBiocompatibility - The Importance of Extractables & Leachables Testing, Whitepapers:White Paper Download Extractables and Leachables Strategies for Pharmaceutical Production TubingWhite Paper DownloadExtractables and Leachables Strategies for Transdermal Patch ProductsWhite Paper DownloadGlass Delamination Studies for Pharmaceutical VialsWhite Paper Download Trace Analytical Methods and Techniques for Testing Extractables and Leachables, Ensuring the Safety and Performance of Electrical Products, Medical Materials and Regenerative Medicine, Hyaluronic Acid Quality Control Testing Services, Orthobiologic and Bone Graft Product Services, Scientific Support Services for Medical Devices, Regenerative Medicine Analysis and Development Support, Design of Robust and Sensitive Extractables and Leachables Studies, Extractables and Leachables Applications: Studies on Process Materials and Container Closure Systems, Biocompatibility - The Importance of Extractables & Leachables Testing. Press| From polymers to alloys to ceramics, we understand how these materials impact safety and effectiveness. NAMSA, heavily involved within these FDA conversations, continues to push for more transparency and consistency from regulators and have requested they provide relevant, contemporary justification for recommendations. Visit NAMSA Client Portal for sample submissions, testing reports, project tracking, and more. In this Perspective, we describe the elements of extractables studies and provide an overview of the current practices, identified gaps, and emerging practices that may be adopted on a wider scale in the future. EAG Laboratories: Material Characterization Experts. Typically, an extractables or exhaustive extractables study will include a range of analytical methods to uncover compounds that are organic, semi-volatile, non-volatile and volatile in nature. Homepage|

Copyright 2012 Woodhead Publishing Limited. Due to the difficulty in obtaining a priori information on all the constituents in finished devices, information generation strategies in the form of analytical chemistry testing are often used. Also known as Chemical Characterization of Materials, Part 18 activities help assess a devices overall biological safety, measure leachables, evaluate material equivalency and help screen new materials for suitability. Heavy MetalsThis USP semi-quantitative test determines whether the total level of metallic impurities that react with the sulfide ion, under test conditions, exceeds the heavy metals limit specified in the individual USP monograph. Copyright 2022 Elsevier B.V. or its licensors or contributors.

Subsequently, during the final product lifecycle these compounds might migrate into the patient body causing unintended harmful consequences. Regulatory bodies are looking for this as part of the assessment of risk associated with your product.

Often this involves developing an appropriate analytical method to test samples taken during process validation and evaluate for reproducibility in critical characteristics. 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ISO 10993-9: Framework for identification and quantification of potential degradation products, ISO 10993-13: Identification and quantification of degradation products from polymeric medical devices, ISO 10993-14: Identification and quantification of degradation products from ceramics, ISO 10993-15: Identification and quantification of degradation products from metals and alloys, ISO 10993-16: Toxicokinetic study design for degradation products and leachables, ISO 10993-17: Establishment of allowable limits for leachable substances, ISO 10993-18: Chemical characterization of materials, ISO 10993-19: Physico-chemical, morphological and topographical characterization of materials. Thus, characterization studies are ultimately performed in order to gain a more complete understanding of a device, and of the risk factors associated with using a device. PBL is FDA registered and is ISO 17025 accredited. While our teams continue to follow FDA and other international regulatory body guidance for extractable and leachable study design, scientific support is not always aligned with regulatory expectations. This testing looks at whether device components, or extracts from a device, have the capacity to cause irritation, damage, or toxicity in an animal system. By using our website, you declare yourself in agreement with our use of cookies. More information on our chemical characterization services can be found here:https://pacificbiolabs.com/chemical-characterization-devices. One of the most critical numbers to find in chemical characterization testing is the threshold of toxicological concern. Total Dissolved SolidsTotal Dissolved Solids (TDS) is a measure of the combined content of all inorganic and organic substances contained in a liquid, typically minerals and salts. Please click Continue to provide your authorization and permanently remove this message. Although non-targeted methods have been adopted by many laboratories, they are laboratory-specific and require expensive analytical instruments and advanced technical expertise to perform.

Melting PointThe melting point of a chemical is the temperature at which a substance changes physical state from a solid to a liquid at normal atmospheric pressure. zeta potential analysis testing characterization