Chester Medical’s Post

𝐂𝐨𝐦𝐩𝐫𝐞𝐡𝐞𝐧𝐬𝐢𝐯𝐞 𝐁𝐢𝐨𝐜𝐨𝐦𝐩𝐚𝐭𝐢𝐛𝐢𝐥𝐢𝐭𝐲 𝐓𝐞𝐬𝐭𝐢𝐧𝐠 𝐟𝐨𝐫 𝐏𝐚𝐭𝐢𝐞𝐧𝐭 𝐒𝐚𝐟𝐞𝐭𝐲 When it comes to medical devices and dental materials, biocompatibility is crucial. Ensuring your products are safe for patients is not just a requirement — it’s a responsibility. Our Comprehensive Biocompatibility Testing services are designed to help you meet the highest safety standards while navigating complex regulatory requirements. 🔬 In-depth testing to guarantee product safety ⚡ Fast, accurate results to keep your timelines on track 📑 Full support for seamless regulatory compliance Ready to ensure your products are safe for patients and compliant with all standards? Let’s make it happen! 📞 949-315-7200 📧 info@biocomptesting.com 🌐 https://lnkd.in/dMYaRWue #BiocompatibilityTesting #PatientSafety #MedicalDevices #DentalMaterials #RegulatoryCompliance #SafeInnovation #Biocomptesting #HealthFirst #SafetyStandards

There's a new updated standard, (EN) ISO 17665:2024, sterilization of healthcare products using moist heat. This document provides requirements for the development, validation, and routine control of moist heat sterilization processes for medical devices. Of course it includes Annex ZA, relationship between the standard and the GSPR requirements of the MDR 2017/745. This sterilization method is primarily used in hospitals, including CSSD Departments, for the sterilization and re-sterilization of medical devices consisting of hard polymers and metals such as PEEK, Titanium and stainless steel. It will also be used for the upcoming EU new classification, class Ir, for the re-sterilization of reusable surgical instruments. Contact us for more information. #medicaldevices #medicaldeviceregulations #mdr

There's a new updated standard, (EN) ISO 17665:2024, sterilization of healthcare products using moist heat. This document provides requirements for the development, validation, and routine control of moist heat sterilization processes for medical devices. Of course it includes Annex ZA, relationship between the standard and the GSPR requirements of the MDR 2017/745. This sterilization method is primarily used in hospitals, including CSSD Departments, for the sterilization and re-sterilization of medical devices consisting of hard polymers and metals such as PEEK, Titanium and stainless steel. It will also be used for the upcoming EU new classification, class Ir, for the re-sterilization of reusable surgical instruments. Contact us for more information. #medicaldevices #medicaldeviceregulations #mdr

Key Packaging Requirements for Medical Devices Sterile Barrier System: Devices intended to be sterile must be packaged in a system that maintains sterility throughout their shelf life and until use (ISO 11607). Material Compatibility: Packaging materials must be compatible with the sterilization method (e.g., steam, ethylene oxide, radiation) and must not degrade over time. Biocompatibility: Materials in direct contact with the medical device must be non-toxic, non-leaching, and safe for users and patients (ISO 10993). Durability and Integrity: Packaging must protect the medical device from mechanical damage, environmental conditions (moisture, temperature), and contamination during shipping and storage (ASTM D4169). Sealing and Closure: The packaging seal must be strong enough to prevent contamination but easy to open in a sterile manner. Sealing processes need to be validated (ISO 11607-2). Labeling and Instructions: Packaging must include clear labeling with essential information, including sterilization status, expiry date, handling instructions, and applicable symbols (ISO 15223-1). Transport and Storage Testing: Packaging systems must be tested to ensure they can withstand environmental stresses, such as vibration, pressure, and temperature variations (ASTM D4169)

Understanding the Rotary Sealing Process for Sterile Barrier Systems (SBS) Ensuring the sterility of medical devices starts with a reliable sealing process. Here’s how a rotary sealer works to create an effective sterile barrier system: 1️⃣ Insertion: The preformed SBS (a pouch or reel) is fed into the side of the heat sealing equipment. 2️⃣ Automation: Depending on the device, the motor automatically engages, guiding the preformed SBS through at a predetermined speed. 3️⃣ Heating: The preformed SBS passes through a heating zone with a defined temperature. This temperature is set during initial installation or validation based on the SBS material. The heat softens the sealing layer of the SBS. 4️⃣ Sealing: The softened layers are pressed together between two contact rollers, creating a secure seal. 5️⃣ Cooling: As the preformed SBS exits the rollers, the material cools down, finalizing the seal. 6️⃣ Protection: The sealed SBS is now ready to protect its contents, ensuring the sterile barrier remains intact until use. 🔬 Sterilization: After sealing, the SBS is sterilized. The porous part of the SBS allows the sterilization medium (e.g., steam) to penetrate and sterilize the medical device inside while keeping contaminants out. Post-sterilization, the SBS maintains sterility until the product is needed. 📋 ISO 11607-2 Compliance: To validate the sealing process, the process variables such as temperature, speed (dwell time), and contact pressure must be monitored. Any deviations from the set parameters must trigger an alert to the operator. 💡 The sealing process is a crucial step in maintaining patient safety and ensuring the functionality of medical devices. #RotarySealer #NanoPak #hawo #SterileBarrierSystem #MedicalDevices #Sterilization #ISO11607 #HeatSealing #MedicalPackaging #PatientSafety

There's a new updated standard, (EN) ISO 17665:2024, sterilization of healthcare products using moist heat. This document provides requirements for the development, validation, and routine control of moist heat sterilization processes for medical devices. Of course it includes Annex ZA, relationship between the standard and the GSPR requirements of the MDR 2017/745. This sterilization method is primarily used in hospitals, including CSSD Departments, for the sterilization and re-sterilization of medical devices consisting of hard polymers and metals such as PEEK, Titanium and stainless steel. It will also be used for the upcoming EU new classification, class Ir, for the re-sterilization of reusable surgical instruments. Contact us for more information. #medicaldevices #medicaldeviceregulations #mdr

Packaging needs in the healthcare industry can be complex – often requiring specifications to align with regulatory requirements and/or significant product protection. Without a packaging partner that has extensive expertise in the space, risks can arise and ultimately impact your bottom line. Click below to see how Shorr partnered with a medical device company to research and implement new packaging that significantly increased the durability of its packaging and decreased risks of contamination during shipping. https://bit.ly/3Vdtz2E #HealthcarePackaging #PackagingPartner #MedicalDevicePackaging #PackagingSolutions #Shorr

Every employee in a medical device manufacturing company holds a responsibility not only to meet regulatory standards but to ensure the safety, quality, and trust that patients place in the products we create. #greenveinhealthcare #motivatonmonday #motivationquote #medical #medical_device #needle #medical_disposables #hypodermic_syringes #hypodermic_needles #syringes

StatLab Medical Products, a manufacturer of medical diagnostic equipment based in McKinney, TX recently started injection molding operations at its new facility in Arlington. https://bit.ly/49hlbEc #Injectionmolding #plasticsindustry #medicalindustry

StatLab Medical Products, a manufacturer of medical diagnostic equipment, based in McKinney, TX recently started injection molding operations at its new facility in Arlington. https://bit.ly/49hlbEc #Injectionmolding #plasticsindustry #medicalindustry