FDA’s Post

Join the discussion on the possible ASCA expansion to include chemical analysis to support medical device biocompatibility.

Whether you are a materials supplier or manufacturer of #MedicalDevices, an important part of chemical characterisation [ISO 10993-18] requirements is the identification of potential extractable substances released from the medical device materials or components. Robust data from controlled extractables and leachables studies can support the equivalence of a proposed material to an established biocompatible material. Find out more about our Medical Device Chemical Characterization and Extractables and Leachables expertise here: https://lnkd.in/e6aKQMEK #ExtractablesLeachables #MedicalDeviceRegulation #MedicalDeviceDevelopment

Another great listen from the Element Lifesciences webinar series... if you are interested in learning more around the critical aspects of medical device characterization then download today! #webinar #medicaldevices #E&L #1099318 #element #productsafety

ChemQuant is home to intuitive chromatography/MS method developers and masters of Shimadzu LC and MS system repair. If your Sciex system has a Shimadzu front end and your LC system is not properly addressed we have a full Shimadzu/Sciex solution coming very soon. No half measures! #Sciex #Shimadzu #service #engineering #method-development #quality #ownership

Medical devices chemical Charecterization Toxicological Risk assessment Biocompatibility testing

Understand key considerations for medical device chemical characterization (E&L assessment). Delve into recent regulatory expectations and changes in the field of medical device chemical testing over the last few years Discuss the chemical characterization process and the associated critical analytical challenges to comply with regulatory and ISO expectations. Register and join us live June 27! https://bit.ly/3X8G7en #Extractables #leachables #medicaldevice #ExtractablesRegulations

New laboratory operation video about GM-1 from GBPI 😊 👩🔧 Application: This instrument can test the coefficient of friction of plastic film, thin sheet, paper and so on. It is applied to quality inspection organizations, drug control institutions, research institutes, packaging, thin film, food companies, pharmaceutical enterprises, personal care industry and so on. Standards: GB 10006-88, ASTM D1894 -01, ISO 8295, Features: 1. Can test independently without computer. 2. LCD display dynamic COF and static COF. 3. Simple calibration of force sensor. 4. Professional software, simple interface, easy to use. 5. Display multiple curves; can zoom curve. 6. Professional test report. Test material: plastic filmm、thin sheet、paper and so on We also have other models of Coefficient Friction Tester, like: GM-4、GM-6、GM-F1 Related videos will continue to be updated, please pay close attention to my account!! ✊ #CoefficientFrictionTester #GBPI #Flexiblepackaging

EMS products are setting the standard for Medical Grade Plastics, especially in terms of biocompatibility. Biocompatible plastics are crucial in ensuring the safety of medical devices, as they must not cause harm to living tissues. Biocompatibility testing evaluates potential irritation, sensitization, and toxicity. The US Pharmacopeia class VI and ISO 10993 test reports confirm the biological safety of various EMS grades, highlighting their excellence in meeting essential requirements for medical applications. #EMS #MedicalGradePlastics #Biocompatibility #MedicalDevices

Are maintenance costs for your clinical chemistry analyzer starting to negatively impact your bottom line? Increasing need for service and repair can be a sign that it’s time to upgrade. Carolina Liquid Chemistries has a full line of new and refurbished analyzers.

🚨 The importance of developing nanoformulations based on mechanistic tools with a Quality by Design (QbD) approach is increasingly evident. 💡This work describes the development of an advanced control strategy and an associated design space for a manufacturing process at a commercial scale. This is an industrial case study of control strategy and design-space definition with the crucial contribution of mechanistic process modeling for an intended commercial manufacturing process. 📊 The design space and control strategy of a manufacturing process are firmly anchored in the concept of quality-by-design (QbD). QbD has been the focus within the last two decades, to advance development and emphasize product and process understanding and process control based on sound science and quality risk management. The fundamental principles are described in the quality guidelines of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q8, Q9 and Q10. In addition, ICH Q11 and ICH Q12 have been elaborated to facilitate the application for marketing authorization and lifecycle management, including the identification of critical quality attributes, development of experimental design space and control strategies for quality assurance, and post-approval change management. https://lnkd.in/dGYb547y