Bruder Consulting & Venture Group’s Post

💥 The US #FDA has released a new draft guidance aimed at enhancing the consistency and reliability of chemical analysis for medical device biocompatibility assessment. 💡 This guidance offers recommended methodological approaches, drawing from the FDA's extensive experience with premarket submissions. It’s designed to support industry professionals and FDA staff in conducting thorough analytical chemistry studies. While these recommendations provide a robust framework, alternative approaches to chemical characterization are also encouraged if they better suit specific needs. 🔍 Manufacturers should tailor their methods to their unique requirements, ensuring compliance with the considerations outlined in the guidance. Follow us for regulatory updates and scientific insights! 💻www.toxhub-consulting.com 📩 info@toxhub-consulting.com #MedicalDevices #FDA #Biocompatibility #ChemicalAnalysis #RegulatoryCompliance #HealthcareInnovation #Premarket

🔬 Elevate Your COD Testing with #CODReactor! "Compliance with regulations" just got easier! The WD325 simplifies your COD testing process with innovative features: ✅ Regulatory Compliance: Meets USEPA 410.4 standards, providing safer and more efficient digestion compared to traditional methods. 🚀 Special COD Program: Press start, and the reactor heats to 150°C for a 2-hour countdown, automatically shutting down with an audio alert. ⚙️ Customizable Settings: Set temperature between 60°C - 200°C, and timer from 1 - 999 minutes, with 3 built-in programs for flexible testing. 🔔 Auto Shut Off & Alarm: Never worry—WD325 stops heating and shuts off with an audio alarm when done! Enhance your lab's performance today! 🔗 Learn more...! visit: https://lnkd.in/d4J9C4Ht for queries, write to us at info@srico-labworld.com or call us at +91 9900674407. #srico #wiggens #labequipment #laboraotryequipment #pharma #pharmaceutical #pharmamanufacturing #rnd #science #qualitycontrol #Qc #chemicalindustry #Pharmaceuticalmanufacturing #petrochemicalindustry #automobileindustry #researchanddevelopment #research #LabEquipment #Innovation #Quality #Sustainability

By embracing a QbD and PAT approach, manufacturers can significantly reduce the R&D timeframe, leading to faster product releases and extending patent life. Optimal’s synTQ platform supports continuous manufacturing, which can cut years off the time it takes for new products to reach the market, giving companies a competitive edge. This process is crucial for industries like pharmaceuticals, where timing is key to success. Explore more about how synTQ can extend patent life and accelerate product development: https://lnkd.in/drC42XRG #ProcessAnalyticalTechnology #PharmaceuticalIndustry #SmartManufacturing

Do you have the CLAP? 😳 I am, of course, referring to the FDA's Chemicals List for Analytical Performance that includes the physicochemical properties of 100 example chemicals and is meant to help medical device sponsors determine whether the chemicals they use in their device development are biocompatible. What did you think I meant? 😜 This list becomes very important when you are looking for a testing laboratory, because you need to know if your chosen lab has the capability and competence to perform the extractables and leachables (E/L) testing that will support biocompatibility of your device. I'm afraid that smaller third-party labs won't offer E/L due to cost, which means that larger testing labs - being the only E/L game in town - will be able to raise their prices with aplomb. Which means the cost of getting your device to market just went up. Again. #medicaldevices #qualitymanagement #compliance #regulatoryaffairs #medtech #biotech #FDA #biocompatibility

FDA published the draft guidance on chemical analysis for biocompatibility assessment of Medical Devices on September 20, 2024. This guidance provides recommendations for the collection and reporting of chemical characterization data that should be used to support medical device market clearance. Contact us for more information. #fda #medicaldevice

Safeguarding the integrity of your pharmaceutical products means ensuring peace of mind at every step. That’s why our 𝗖𝗖𝗜𝗧 𝗹𝗲𝗮𝗸 𝘁𝗲𝘀𝘁 𝘀𝗮𝗺𝗽𝗹𝗲𝘀 are designed to help you protect what matters most: product and patient safety. Here’s how we ensure precision and reliability at every step: ✅ 𝗣𝗿𝗲𝗰𝗶𝘀𝗶𝗼𝗻 𝗲𝗻𝗴𝗶𝗻𝗲𝗲𝗿𝗶𝗻𝗴: Our advanced laser technology creates smooth-edged pinholes with accurate flow-to-diameter correlation. ✅ 𝗩𝗲𝗿𝘀𝗮𝘁𝗶𝗹𝗲 𝗽𝗶𝗻𝗵𝗼𝗹𝗲 𝗰𝗿𝗲𝗮𝘁𝗶𝗼𝗻: We certify pinholes from <5 micrometers to 1 mm in glass, plastic, rubber, and metal, covering a wide range of containers. ✅ 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗲𝗱 & 𝘁𝗿𝗮𝗰𝗲𝗮𝗯𝗹𝗲: Each sample is QA certified and traceable with unique codes. ✅ 𝗣𝗼𝘀𝘁-𝘂𝘀𝗮𝗴𝗲 𝘃𝗲𝗿𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻: Re-certification after use ensures continued reliability. ✅ 𝗙𝗹𝗼𝘄 𝗺𝗲𝗮𝘀𝘂𝗿𝗲𝗺𝗲𝗻𝘁 𝗼𝗳 𝗰𝗿𝗮𝗰𝗸𝘀: We certify flow through cracks to confirm leakage. ✅𝗩𝗶𝘀𝘂𝗮𝗹 𝘃𝗲𝗿𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻: Pinhole diameters are verified with ultra-microscopy. ✨ 𝗡𝗲𝘄 𝗳𝗲𝗮𝘁𝘂𝗿𝗲 coming soon: We produce samples with a certified gas composition in the headspace. This capability ensures that the  gas surrounding the sample meets specified certification standards,  providing an added layer of control and accuracy to your leak  testing procedures. Let us help you maintain the highest standards in pharmaceutical manufacturing, just as we do for industry leaders around the world. 𝗗𝗼𝘄𝗻𝗹𝗼𝗮𝗱 𝗼𝘂𝗿 𝗳𝗮𝗰𝘁𝘀𝗵𝗲𝗲𝘁: https://lnkd.in/eeDVEz6W #PharmaIndustry #Pharmaceuticals #CCIT #LeakTesting #Innovation #QualityControl #PharmaManufacturing

On November 6th at 12pm EST, join Kyle Rose for an exclusive webinar covering 3 major FDA regulatory updates that will impact your compliance strategy: 1. Draft Guidance on Chemical Analysis for Biocompatibility Assessment for Medical Devices 2. FDA's Recognition of New Sterilization Standards 3. LDT Final Rule - Stage 1 Requirements 💡 Learn what each update entails, key takeaways, and expert tips for staying compliant. Don’t miss this chance to stay ahead of these important changes—register today! Reserve your spot here: https://lnkd.in/dXatxFS7 #MedicalDevices #FDA #Regulatory #Compliance #Biocompatibility #Sterilization #LDT #Webinar #LookToRook

The world of chemistry, manufacturing, and controls (CMC) can be complex and demanding. At Onyx Scientific, we simplify the process, allowing you to focus on what matters most - developing life-changing medicines. Our CMC services include: 🧪Chemistry development: Expert synthesis and optimisation of your drug candidate for efficient manufacturing. 🔬Analytical development: Robust analytical methods to ensure the quality and purity of your drug product. 💊Solid form development: Integrated solid form development designed to de-risk progression into formulation development. 🏭Manufacturing: Large-scale production adhering to the highest quality standards. 📑Regulatory support: Expert guidance through the regulatory landscape. #CDMO #CMC #SmallMoleculeAPI #Chemistry

🔬 Ensuring Product Safety with Advanced Container Closure Integrity Testing (CCIT) In the pharmaceutical and biotech industries, product integrity isn't just a priority—it’s non-negotiable. That’s where advanced CCIT technologies step in, safeguarding products from contamination, degradation, and compliance risks. ⚙️ What We Bring to the Table: ✅ Non-destructive testing methods for efficient quality control ✅ High-sensitivity techniques (vacuum decay, pressure testing, etc.) ✅ Automated solutions for increased precision and throughput ✅ Regulatory compliance aligned with FDA, EMA, and USP standards With innovations like AI-powered analytics, IoT-enabled monitoring, and automated testing, we are redefining how companies achieve seamless product integrity and compliance. Because when it comes to product safety, integrity matters—and so do the technologies we trust. PTI - Packaging Technologies & Inspection LIGHTHOUSE Instruments #CCIT #ContainerClosureIntegrity #PharmaTech #AdvancedTechnologies #QualityControl #ProductIntegrity #PharmaceuticalInnovation

Testing your clean room is essential to achieve contamination-free research and manufacturing as well as efficient operation and financial saving. Manufacturers of semiconductors, flat panel displays, and memory drives have extremely high requirements, and biotech and pharmaceutical companies, medical device manufacturers, healthcare facilities and other organizations that produce, store and test their products are regulated by law. The sensitive technologies handled in clean rooms require careful vigilance—a single speck of dust, for example, has the potential to destroy a semiconductor’s microscopic electronic components. To maintain a controlled environment, clean rooms are pressurized with filtered air, regulated by ISO, IEST and cGMP standards, and tested annually with the correct equipment and methods which SGS can help with.