EngMotion - Automated Filling and Compounding Solutions for the Medical Sector’s Post

It is one of the fundamental building blocks of quality management in medical technology: #validation. However, specific instructions or a “one-size-fits-all” recipe are often sought in vain. This is because validation is process-dependent and is determined by a large number of process-related variables. Use our practical decision matrix and check in advance whether validation is necessary or not. 👉 https://lnkd.in/gfxXMdTE Novoplast Schlauchtechnik | FLEIMA-PLASTIC GmbH | Masterflex Group

Unlock the Secrets of Packaging Validation! Ensuring compliance with ISO 11607 is crucial in the world of medical packaging. Validation is the key, confirming sterile barrier integrity and consistent quality. Discover the intricacies of validation, from defining process variability to establishing acceptance criteria. Learn about sealing qualification and essential tests like shelf life and transportation simulation. You can find all the insights in our FREE whitepaper: https://lnkd.in/d6b3S8Rt Dive deeper into packaging validation with Früh Verpackungstechnik and let's drive excellence to-gether! #Protect2Perform #PackagingValidation #MedicalPackaging #Whitepaper

Ensuring the control of nonconforming product is crucial for maintaining the quality and safety of medical devices. This week's MedTech Compliance Chronicles post delves into the essential requirements and best practices for identifying, documenting, and segregating nonconforming products, as well as the protocols for rework and repair. Learn how to effectively manage nonconformities to prevent unintended use and ensure regulatory compliance. Read more to understand the core principles and practical applications in the medical device industry. #QualityManagement #MedTech #RegulatoryCompliance #NonconformingProduct https://lnkd.in/d34eWUEZ

🔴 Understanding CAPA and Non-Conformance 🛡 Corrective and Preventive Actions (CAPA) and identifying non-conformance are critical concepts in the MedTech industry, ensuring the highest standards of quality and compliance. But how do these principles apply to real life, especially in the case of a product failure affecting a patient? Let's explore. 🚗 Imagine you’re planning a road trip. Midway, you encounter a flat tire (the problem). Here's how CAPA principles and non-conformance would guide your response: - Non-Conformance: Recognize the flat tire as a deviation from the expected, reliable state of the car. - Corrective Action: Fix the flat tire immediately. This solves the current issue and gets you back on the road. - Root Cause Analysis: Investigate why the tire went flat. Was it due to a nail, poor tire maintenance, or something else? - Preventive Action: Take steps to prevent future flats. This could include checking tire pressure regularly, avoiding debris on the road, or investing in better quality tires. In a MedTech context, these principles work similarly, but the stakes are much higher. Consider a scenario where a medical device, such as a continuous glucose meter, fails and adversely affects a patient. Here's how CAPA would apply: > Non-Conformance: The failure is identified as a deviation from the product's intended performance. > Corrective Action: The immediate response involves recalling the affected batch of glucose meters to prevent further incidents. The company provides immediate support and alternatives to affected patients to ensure their safety. > Root Cause Analysis: A thorough investigation is conducted to determine the cause of the failure. Was it due to a manufacturing defect, a software glitch, or improper usage? Detailed analysis is essential to identify the root cause. > Preventive Action: Based on the findings, the company implements changes to prevent recurrence. This could include revising the manufacturing process, enhancing quality control measures, updating software, and providing additional training for both employees and end-users. By embracing CAPA and promptly identifying non-conformance, we can enhance quality, improve processes, and prevent future issues. It's about learning from our experiences and striving for continuous improvement to ensure patient safety and product reliability. #capa #nonconformance #quality

Why Transit Simulation Testing for Medical Device Packaging is essential? For packaging manufacturers, it gives a clear signal to customers that you are able to make ISO-quality packaging. The ISO 116071 states that protective packaging should be provided for products during transport and storage. It defines the protective and sterile barrier elements of the packaging. Benefits to Packaging Companies of Holding ISO Accreditations Quality is an important requirement for many packaging companies, and ISO accreditations support quality objectives. Adhering to ISO standards can: ✅The distinction between your products arriving undamaged or safely. ✅It boosts sales. ✅Positively impact your packaging company's performance and reputation. ✅Above the expectations of the client. ✅Lean and effective production management can help cut expenses. ✅Provide a completely optimal response to a design brief for packaging. ✅Assist you in adhering to packaging laws and regulations. ✅Resolve issues with your workflows to increase output. ✅Contribute a unique viewpoint to the production process. learn more about Transit Packaging https://lnkd.in/eaNGjZ5q #transitpackaging #TransitSimulationTestingforMedicalDevicePackaging

🔬 Introducing Supera Fulfillment's New Aliquoting Service 🔬 We're excited to roll out our high-precision aliquoting service, tailored to meet the unique demands of today’s fast-paced labs—all backed by our ISO 13485 certification for top quality and compliance in medical device and lab support services. What makes our aliquoting service stand out? ✨ ISO 7 Cleanroom – We aliquot in a controlled ISO 7 cleanroom environment, ensuring contaminant-free processing for sensitive workflows. ⚙️ State-of-the-Art Hamilton Star Technology – Our Hamilton Star offers unmatched precision, handling aliquots from microliters (uL) to liters (L) with both speed and accuracy. This technology supports flexible workflows, reducing time to results for high-throughput labs. 🧪 Formulation and Filling Options – Whether you need us to formulate and fill from scratch or aliquot a specific buffer or reagent you supply, we've got you covered. We can work with your proprietary solutions or any off-the-shelf reagents. 📦 Versatile Tube Capacity – From 2 mL screw caps to 50 mL conicals, we’re set up to meet your lab's specific needs. 📋 ISO 13485 Certification – Quality, compliance, and reliability are our top priorities, and our ISO 13485 certification underscores our commitment to meeting rigorous standards every step of the way. Our team is committed to maintaining exacting standards for quality and efficiency at every stage. Contact us today to discuss how we can help streamline your lab’s aliquoting needs and reduce your internal burden. #LabSupport #PrecisionAliquoting #HamiltonStar #ISO7Cleanroom #SuperaFulfillment #LaboratoryEfficiency #QualityControl #ScienceSupportingScience

Interesting fact ; If you have anything custom built, like business desk systems, laboratory equipment for pharma, canning machines, industrial machinery that makes practically anything you can think of… it will need some sort of safety testing by a NRTL to prove it’s safe to use as per the standard(s). A solution to your needs = QAI Laboratory Message me ! #QAI #LADBS

Great week at #MMIC continuing the implementation of the #digitalQPPlatform and the PACE #automatedGMP packing line. Can we receive a clinical IRT on-demand order for one patient bottle, fill it, seal it, label it and QP certify it in 15 minutes? All without the need for traditional human QC checks? The #PACE automated packing line does just that, with automated GMP verified steps and automated QP data verification. Zero human errors. PACE, developed through #CPI #innovation project and manufactured by #AutomatedIndustrialRobotics with #digitalQPPlatform developed by #Siemens has proven that the industry can move away from reliance on human QC checks to digital #QualityVerification. #digitalqp #digitalisation #gmpautomation Read more here: https://lnkd.in/eA3t_sAW

If old drug formulation tools can only process 10 samples at a time How do we run 1000 samples on them? 😥 That was the fundamental challenge when we started Persist We had a few options: 1/ Automate the existing tool so we can run it 24/7 2/ Re-engineer the existing tool from scratch We chose Number_2 and never looked back We're rebuilding the tools used by the industry, so they generate better quality data, in higher throughput, with a focus on hands-free operation I think it differentiates us from automation companies that just focus on Number_1 above If we're not willing to rebuild from scratch, we quickly get limited by the tools that exist

Wondering about our production part approval process? 👋🏼 This structured approach used in #MedicalDevice manufacturing ensures that components, materials, and manufacturing processes consistently meet specified requirements. It involves the submission of comprehensive documentation, initial sample inspection, evaluation, and ongoing monitoring and control. Check it out here → https://bit.ly/45ox0Zh