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Heavy Metals Testing - ICH Q3D
In June 2016 the U.S. Food and Drug Administration (FDA) issued draft guidance for industry on elemental impurities in drug products. The new guidance provides recommendations to assist manufacturers to comply with the International Council for Harmonisation (ICH) guidance for industry Q3D Elemental Impurities and the revision of the 'Heavy Metals Test' used in the United States Pharmacopeia/National Formulary. Both of these changes came into force in 2018.
In addition, from 1 June 2016 the European Medicines Agency (EMA) adopted the ICH Q3D guidance for new marketing authorization applications. As the Agency's evaluations form the basis of authorization of medicines in Europe, all manufacturers who are planning to market new drug products in Europe should act now to ensure that they comply with ICH Q3D Elemental Impurities guidance.
We work to ICH Q3D guidelines, helping manufacturers to be ready for the forthcoming new standards.
Using our extensive experience of elemental impurity testing we will guide you through the ICH Q3D and USP <232> and <233> requirements, developing a customized package of analysis to ensure that you comply with the recommended ICH Q3D guidelines as required by the appropriate regulatory authority.
Using ICP-MS (Inductively Coupled Plasma Mass Spectrometry) we are able to identify elements by their individual masses and isotopic fingerprints, with detection limits as low as parts per trillion (ppt) in some cases.
We are fully GMP certified for quality control testing of human and veterinary medicinal products (full documentation is available to download on the right of this page). All Lucideon's services are undertaken in compliance with EU guidance on GMP as it applies to contract QC testing laboratories. We are MHRA-inspected and were successfully re-accredited in September 2016. Lucidedon's GMP Laboratories in the UK were also successfully inspected by the FDA (U.S. Food and Drug Administration) in September 2019.
On Demand Webinars
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Advancing Vascular Devices Through Innovative Fatigue Testing & Particulate Evaluation
In this webinar, host Joe Foroughi, Chemistry and Microanalysis Manager at Lucideon, is joined by Dynatek's Director of Global Sales, Kendra Conti. The webinar highlights how various changes in standards have affected the testing landscape for vascular devices and their delivery systems. As OEMs continue to see regulators asking for more data and greater justification in their processes, we look at what the standards are really asking for, and how to best meet the requirements for a variety of devices.
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Meet the MaterialsMatrix!
Want to know more about the MaterialsMatrix, the free community for everyone interested in materials? Watch this webinar to find out more about how you can network, learn and collaborate in this new online community.
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Collaboration is Key: Unlocking the Changes to ISO 10993
In this webinar, we are joined by toxicology experts, bibra toxicology advice and consulting. We discuss recent changes to the ISO 10993-18 and the upcoming changes to 10993-17 and how they impact medical device makers in particular with toxicology assessments. A focus is given to how these changes encourage a more unified approach to the process as a whole and we present on the benefits of assessing both the -17 and -18 components of this standard in collaboration.
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Using Surface Science to Improve Consumer Products
This webinar, presented by Aia Malik and Michelle Chen, explores how the use of surface science is improving product development through 3 key areas: • product insight – understand the intricacies of the mechanism of action and dig deeper into product performance • troubleshooting – get faster solutions and use tools that detect and deliver more than bulk techniques • claims support – back your product claims with strong evidence; tell a story and convey it through powerful imagery.
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Oxidation Kinetics in Titanium
Titanium is one of the most widely used alloys for medical device applications due to its strength, corrosion resistance, and biocompatibility, amongst other characteristics. It is also has form and manufacture versatility. However, one of the most challenging phenomena with the use of titanium is oxidation. Whether intentional or unintentional, the process by which oxides form must be understood and well controlled to ensure optimal performance of any medical device. In this webinar, Julius Bonini explores the various reactions, phenomena, and challenges associated with titanium oxidation, exploring thermodynamics, atomic diffusion, and a whole lot more.
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The Use of Surface Science for Solving Pharmaceutical and OTC Product Challenges
Pharmaceutical and Consumer Healthcare / OTC manufacturers are continually faced with a variety of issues throughout their development and manufacturing processes. These include, but are not limited to contamination, formulation and tablet discoloration, packaging incompatibilities, and major product failures. Our advanced analytical method development service allows our clients to implement and validate methods to evaluate their products, and our world class surface science suite is leveraged for troubleshooting and counterfeiting investigations. In this webinar, Ursula Thompson will explore how such techniques can be used for solving the aforementioned challenges.
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The Use of Surface Science for Solving Cardio and Neurovascular Device Challenges
Cardiovascular and Neurovascular device manufacturers continue to innovate the surfaces of implants for improved clinical performance, enhanced therapeutic action, and market differentiation. The innovation can be achieved through changing materials, functionalizing surface chemistries, applying coatings, or employing processing treatments, to name a few. However, as with any innovation, challenges can arise - e.g. poor coating adherence on the surface of neurovascular stents; inconsistent pharmaceutical active loading on the surface of drug coated cardiovascular balloons; or pitting corrosion on the surface of overlapping stents. These are just a few of the many challenges encountered in the industry. As we collaboratively work to root-cause issues, optimize processes, and implement corrective actions, visualizing and quantifying surface chemistries and morphologies is paramount. In this webinar, Ursula Thompson explores various surface analysis techniques used to achieve these aforementioned goals.
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Powder Issues Associated with Metal Additive Manufacturing
In this webinar Julius Bonini, principal consultant, metallurgy at Lucideon, discusses the finer details of metal powders used in additive manufacturing. He covers topics including: the three most common methods of metal additive manufacturing, how metal powders are made, how you can test and evaluate your powders and products, and the challenges that the industry still faces in exploiting the full potential of metal additive manufacturing.
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Post Processing Issues Associated with Metallic Medical Components
There are a wide range of post-processing treatments for medical devices. The best option for each device will depend on many factors, such as: material, manufacturing technique, final application and product geometry, and understanding the processes and key factors is crucial to achieving the best finish. This webinar series, hosted by our leading metallurgy expert Julius Bonini, takes a broad look at the range of treatments available and the typical effects of each.
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Single Tooth Restorations and Dental Treatments of the Future
Presented by Anike Bütow, Technology & Strategy Leader at Lucideon, this webinar discusses the challenges and drivers facing the dental industry, with a particular focus on caries.
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Wear Testing - Load-Control vs. Displacement-Control
In the second part of our “What the Standards Don’t Tell You” series, we dig a little deeper into ISO 14243, the wear testing standard for total knee replacements. Not every knee replacement is made equal, nor is every knee system suitable for every patient. How do you know that your design is being tested for its intended application?
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Ceramic Forming Techniques
A wide range of techniques are employed to form ceramic components, with each technique having specific advantages and disadvantages. In this webinar, Richard White and Mike Salt discuss these techniques, and how and why they are chosen, with regards to advanced ceramics.
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Novel Materials Development to Address Dental Sector Needs
In this webinar, presented by Dr Phil Jackson and Delihta Fernando, we explore the important drivers facing the dental industry and discuss the potential roles that novel materials could play as 'enablers'.
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Cleaning Issues with Additive Manufactured Devices
While this general topic has been covered in various webinars in the past, here we isolate several key aspects of the problem. The unique porous coated surfaces of new additively manufactured (AM) medical implants have proven to be quite complex and are creating challenges with respect to effective cleaning.
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Common Post-Processing Treatments for Additive Manufactured Components
This webinar, presented by Julius Bonini, Principal Consultant, Metallurgy, covers all of the common post-processing treatments applied to additively manufactured (AM) metal components. Topics related to the removal from build plates and stress relieving of as-fabricated parts to more complex processes such as machining, cleaning and surface finishing, are covered.
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Validation of Additive Manufactured Components through Specialized Testing
In this webinar, Julius Bonini, Principal Consultant, Metallurgy, explores a number of analysis techniques that can be used to provide insightful competitive advantage through design and performance evaluation.
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DoE (Design of Experiments) and Statistical Interpretation of Test Data
Presented by Dr Gilda Gasparini, Chemical Engineer, and Dr Phil Jackson, Technical Manager, both of Lucideon's Healthcare division, the webinar focusses on the benefits that design of experiments affords in terms of product optimization, time and cost savings, and yield improvement.
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Understanding Polymer Structure and Processing to Minimize Failures
Hosted by Dr Richard Padbury, polymer technology consultant at Lucideon, this webinar looks at the beneficial properties of polymers in a range of applications and how these can be best utilized. The webinar will appeal to design engineers, mechanical engineers and polymer scientists, and anyone who works with polymers who needs to learn more about the intricacies of polymer behavior.
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Chemical Imaging of Industrial and Healthcare Materials by ToFSIMS
Hosted by Dr Chris Pickles, consultant to Lucideon, the webinar looks at the application of surface science techniques in industry to provide understanding of the distribution of ingredients in materials, with a specific focus on healthcare applications.
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The Art of Solving Coatings Challenges through Microchemical Analysis
In this webinar, hosted by Gary Kagel, we explore various microchemical techniques, their uses and limitations, and how to most effectively solve key coatings challenges.
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Perspectives on Extractables - Pharmaceutical Products and Medical Devices
Medical devices and pharmaceutical products can present a risk to patients by way of exposure to substances present in manufacturing or packaging materials. This webinar, presented by Craig Donald and Malcolm Rose, discusses how to understand and evaluate those risks by following the procedures set out in ISO 10993.
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Failure Analysis - What Engineers Need to Know
This webinar, presented by Sara Randall, Senior Materials Engineer, describes the general processes applied to a typical failure analysis of a metal component.
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Your Metal Component Has Failed in Fatigue - What do you do next?
This webinar, presented by Julius Bonini, Principal Consultant, Metallurgy, provides a blueprint for the typical procedures which should be applied when a component fails in fatigue.
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Cleaning Validation of Reusable Medical Devices
This webinar, presented by Craig Donald, discusses reusable medical devices (such as surgical tools, etc.) which need to be cleaned and/or sterilized before each use. Manufacturers are required to validate their cleaning/sterilization instructions accordingly. The webinar addresses a range of factors to consider when developing such protocols.
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Ensuring Quality & Standardization in Powder Metal Input for Additive Manufacturing
Hosted by Joan Morra, Metallurgical Engineer, and Dr Phil Jackson, Technical Manager, Healthcare, this webinar covers the importance of powder quality and optimization for successful Additive Manufacturing processes.
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Additive Manufacturing for the Healthcare Sector - Challenges and Issues
This webinar, presented by Julius Bonini, Principal Consultant, Metallurgy, highlights and discusses several issues associated with additive manufacturing (AM) technology that the medical implant and device community are currently facing.
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Wear and Mechanical Testing of Hips and Knees - What the Standards Don’t Tell You
This webinar, presented by Ramiro Alan Ramirez and Kevin Night, discusses: common standards - what they cover and what they don’t and areas that require unique test methods including: coatings of devices; ageing of devices; adverse wear testing; dynamic testing of acetabular components and adapting simulators to emulate joints without available standards.
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Additive Manufacturing of Metallic Components - The Metallurgical Perspective
This webinar covers metal additive manufacturing, various methods & equipment, E Beam vs. laser melting methods, powder bed vs deposition methods & available metal systems
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The Use of Imaging for Claims Support
Presented by Dr Chris Pickles, this webinar focusses on how chemical mapping and topographical profiling can be used to support product claims.
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Validation and Quality Assurance of Medical Device Cleaning Processes
Presented by Dr Chris Pickles and Stuart Watson, the webinar covers current regulatory guidance, residues and sources of contamination, and how to identify contaminants and their source via surface, gravimetric and residue analysis.
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How Clean is Your Device? - The Use of Surface Chemical Analysis for the Validation of Device Cleaning Processes
Presented by Dr Chris Pickles, this webinar covers the use of surface chemical analysis for the validation of device cleaning processes and discusses how surface and chemical analysis can be used to validate the cleaning processes of medical devices.