Steelco Group’s Post

Looking for reliable contamination sampling in aseptic manufacturing? Check out this video featuring the AeroTrak™+ Remote Active Air Sampler. Purpose-built for these environments, it aligns with FDA, European Commission, and WHO standards. Unlike generic samplers, it's engineered to detect viable contamination effectively without adding risks itself. Stainless steel construction ensures safety, while its integration with our FMS Software ensures data integrity and easy compliance. Plus, it seamlessly shares data via OPC UA. #pharmaceuticalmanufacturing #FDA #WHO #european commission #aseptic https://lnkd.in/edz4HakQ

💡 𝐇𝐨𝐰 𝐝𝐨 𝐲𝐨𝐮 𝐫𝐞𝐝𝐮𝐜𝐞 𝐜𝐨𝐧𝐭𝐚𝐦𝐢𝐧𝐚𝐭𝐢𝐨𝐧 𝐫𝐢𝐬𝐤𝐬 𝐢𝐧 𝐲𝐨𝐮𝐫 𝐜𝐥𝐞𝐚𝐧𝐫𝐨𝐨𝐦? The key lies in 𝐂𝐥𝐞𝐚𝐧𝐫𝐨𝐨𝐦 𝐌𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠. This critical process ensures that industries, especially those in healthcare and pharmaceuticals (GxP industry), maintain sterile environments essential for high-quality production. 𝐇𝐨𝐰 𝐢𝐭 𝐰𝐨𝐫𝐤𝐬 👇 Our Cleanroom Monitoring System keeps your cleanroom at peak performance by tightly controlling key parameters like temperature, humidity, CO2, and particle counts. 🌡️ With a combination of high-end sensors, validated software and professional services (IQ/OQ protocols), we provide a customized monitoring solution tailored for your cleanroom operations. 𝐇𝐞𝐫𝐞’𝐬 𝐡𝐨𝐰 𝐨𝐮𝐫 𝐜𝐥𝐞𝐚𝐧𝐫𝐨𝐨𝐦 𝐦𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 𝐟𝐮𝐧𝐜𝐭𝐢𝐨𝐧𝐚𝐥𝐢𝐭𝐲 𝐠𝐮𝐚𝐫𝐚𝐧𝐭𝐞𝐞𝐬 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐚𝐧𝐝 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: 🌡️ 𝐌𝐮𝐥𝐭𝐢-𝐩𝐚𝐫𝐚𝐦𝐞𝐭𝐞𝐫 𝐦𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠: Monitor critical factors like temperature, humidity, CO2 levels and particles simultaneously with our ISO 17025 calibrated Rmoni sensors. 🔒 𝐃𝐚𝐭𝐚 𝐢𝐧𝐭𝐞𝐠𝐫𝐢𝐭𝐲 & 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: Our validated software guarantees data accuracy, meeting regulatory requirements and providing reliable records for audits and inspections. 🔗 𝐒𝐞𝐚𝐦𝐥𝐞𝐬𝐬 𝐬𝐲𝐬𝐭𝐞𝐦 𝐢𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧: Easily integrate Rmoni’s monitoring solutions into your infrastructure, unifying systems on one platform via an open API. 📊 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: Cleanroom monitoring by Rmoni meets all specific regulations and quality standards within the GxP industry (FDA 21 CFR Part 11 and EU GMP Annex 11) Curious about how cleanroom monitoring can elevate your industry standards? Check out our Cleanroom Monitoring functionality👉 https://lnkd.in/ew3KNiwZ #FDA21CFR #GMP #cleanroommonitoring #qualitycontrol #rmoni #compliance #GxPmonitoring

Be informed to upcoming FDA notice for medical and cosmetic electrical equipment with incorporated laser. FDA intends to withdraw yet valid Laser Notice No. 50 and intend to replace it with a new Laser Notice No. 56.🔖 This change has a direct impact on conformity assessment of IEC60825-1 ed.2 and IEC60601-2-22 ed. 3, since these standards will not anymore be accepted under the new notice. Medical manufacturers have still time till end of 2024, to upgrade their existing IEC60825 and 60601-2-22 Test reports to the latest edition of the standards and compy with upcoming FDA regulations. Also a very positive news is, that under certain circumstances described in this guidance, fulfilling the IEC 60825 ed.3 and IEC 60601-2-22 ed. 3.1 would provide aduquate proof of protection to public health and laser safety, therefore it could mean automatically compliance to FDA. We at Eurofins E&E Product Testing AG - Schweiz are accredited to above mentioned laser standards and are happy to support you with any information required ℹ️ For more information feel free to reach out to me 📞

ISO 18562-3:2024 specifies tests for measuring emissions of volatile organic substances from gas pathways in respiratory care devices, ensuring compliance with criteria over their lifetime. It excludes biological evaluation of direct contact surfaces (ISO 10993) and covers devices like ventilators and anaesthesia workstations, but not gas source contamination. 👇 Check out the video carousel to know more! #MedicalDevices #RespiratoryCare #VolatileOrganicCompounds #MedicalDeviceStandards 

Looking for traceable and compliant sterility testing? Our latest white paper on the Sterisart®️ Universal Pump provides a comprehensive compliance checklist for 21 CFR Part 11 and EU GMP Annex 11. This essential guide covers everything you need to support your regulatory adherence. Key Highlights: ✅ Advanced Connectivity: Seamlessly integrates with your existing lab systems for efficient data management. ✅ Electronic Record Keeping: Ensures accurate and reliable electronic records, meeting stringent regulatory requirements. ✅ Data Integrity and Audit Trail: Maintains comprehensive audit trails to ensure data integrity and facilitate regulatory compliance. The Sterisart®️ Universal Pump is designed to meet these stringent requirements, featuring a barcode scanner, electronic reporting with electronic signatures, and robust system access controls. Our white paper also provides recommended customer actions, including setting print profiles, time-controlled actions, user training, document control, and change control procedures. Download now to learn more: https://ow.ly/t0TO50SzunR #sterilitytesting #21CFRPart11 #EUGMPAnnex1 #compliance #qualitycontrol

Stakeholders, make yourself heard today! Have you used the updated Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices from IMDRF? 'Essential Principles' was initially published to promote "harmonized" principles related to the design and manufacturing of IVD medical devices. Now, you have a chance to offer feedback. We're polling individuals regarding the document's efficacy and what other resources would be helpful. Survey: https://lnkd.in/eYt2hcGx Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices: https://lnkd.in/e3-Kcbq5

ISO 18562-4:2024 outlines the testing methods for assessing the particulate matter emissions from medical devices that provide respiratory gas pathways. ISO 18562-4:2024 is crucial for ensuring patient safety by minimizing exposure to harmful particles during respiratory treatments. 👇 Check out the video carousel to know more! #ISO18562 #MedicalDevices #PatientSafety #HealthcareStandards #RegulatoryCompliance #ISOStandards #RespiratoryCare

Want to understand 21CFR Part 11 in Sterilty testing ? Download our latest white paper to understand the future of Sterilty testing #USP71 #21CFR #EUGMPAnnexe #sterilitytesting

While already ISO 9001 certified, Greenville-based manufacturer 411 INDUSTRIES L.L.C. was interested in expanding to the medical device industry and requested that TMEP, part of the Manufacturing Extension Partnership (MEP) National Network™, facilitate an ISO 13485 gap analysis incorporating both of their manufacturing locations. The gap analysis is important to identify discrepancies between the existing ISO 9001 quality management system and the requirements outlined in ISO 13485:2016. Read more about 411 Industries LLC success with ISO 13485 gap analysis identifying new investment opportunities at: https://lnkd.in/esx3Qj4D Learn more about how TMEP can help you implement Quality Management Systems at your manufacturing plant at https://lnkd.in/e5NdcmDi #Manufacturing #ISO9001 #ISO13485 #QualityManagement #ManufacturingIndustry #MEPNationalNetwork #InvestmentOpportunities #MedicalDevice #GapAnalysis #consulting #casestudy #successstory #eastTN

Did you know ISO 10993-17, published in September 2023, is already recognized as a consensus standard by the FDA? 📅 The transition period for submitting documents compliant with the new standard to the FDA has been set at 3 years; therefore, starting from December 2026, the Agency will only accept Toxicological Risk Assessment (TRA) prepared in accordance with the 2023 standard. Do you need to comply with the new standard? Our Eurofins experts are ready to support you! 👉 Contact our Business Development Manager Anja Kroon to discuss and develop a customised plan to ensure compliance and get ready in time. #Eurofins #TestingForLife #MedicalDevices #Compliance #NewStandard #Testing #Consultancy #FDA #ISO10993