Robert Golebieski

How to Optimize Your Medical Injection Molding Process: To consistently mold components that meet quality control specs and reduce development hours for customers, follow these steps.

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𝐅𝐢𝐯𝐞 𝐓𝐡𝐢𝐧𝐠𝐬 𝐘𝐨𝐮 𝐃𝐢𝐝𝐧'𝐭 𝐊𝐧𝐨𝐰 𝐀𝐛𝐨𝐮𝐭 𝐃𝐞𝐯𝐢𝐜𝐞 𝐃𝐞𝐬𝐢𝐠𝐧 𝐔𝐧𝐢𝐪𝐮𝐞 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬 𝐨𝐟 𝐋𝐲𝐨𝐩𝐡𝐢𝐥𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐃𝐞𝐯𝐢𝐜𝐞 𝐃𝐞𝐬𝐢𝐠𝐧 Designing a device that can be specifically used for #lyophilization presents certain unique challenges. Unlike traditional liquid-based #injection devices, lyophilization devices must be designed to accommodate the freeze-drying process, which requires precise control of temperature, pressure, and airflow to ensure that the product's integrity is maintained throughout the process. 𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐌𝐮𝐥𝐭𝐢𝐩𝐥𝐞 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐢𝐞𝐬 When designing a lyophilization device, it is often necessary to bring together several technologies into a single system. These may include #temperaturecontrol systems that need to be precise, vacuum chambers, and in some cases, robotics to handle vials or cartridges during the process. It can be a challenging to coordinate these technologies and make them work together seamlessly. 𝐌𝐢𝐧𝐢𝐚𝐭𝐮𝐫𝐢𝐳𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐏𝐨𝐫𝐭𝐚𝐛𝐥𝐞 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 The demand for portable medical devices, including lyophilization devices, is on the rise, especially for use in field applications or point-of-care settings. To create a compact lyophilization device that is portable yet still meets the required functionality and performance standards, innovative engineering solutions are necessary. This may include the use of microfluidics and advanced materials. 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐇𝐮𝐫𝐝𝐥𝐞𝐬 𝐚𝐧𝐝 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 Ensuring regulatory compliance is a crucial part of designing medical devices, and lyophilization devices are no different. The designers must navigate intricate regulatory frameworks, including FDA guidelines and international standards, to ensure the device's safety, effectiveness, and quality. This usually involves carrying out extensive testing and validation procedures throughout the design and development process. 𝐔𝐬𝐞𝐫-𝐂𝐞𝐧𝐭𝐫𝐢𝐜 𝐃𝐞𝐬𝐢𝐠𝐧 𝐟𝐨𝐫 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐏𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥𝐬 In addition to meeting regulatory requirements, lyophilization device designers must also consider the needs and preferences of healthcare professionals who will use the device. This includes factors such as ergonomics, ease of use, and compatibility with existing clinical workflows. Conducting user research and incorporating feedback from clinicians can help optimize the design for real-world usability. #drugdelivery #pharma #pharmaceutical #biotech #biologics #vaccines Max Kingsley Hannon Maria Beatriz Inacio George Fryett Ginny Simpson Flora Koska Paul Rutter Edward Kelley

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🚀 Exciting News for Medical Device Manufacturers! 🚀 Comment 81 to the FDA's QMSR addresses the QSIT. 🔎 With the new QMSR, the Quality System Inspection Technique (QSIT) 𝗺𝘂��𝘁 change. Currently in it's 1999 version and based on the 1996's QSR, the FDA is gearing up for a 𝗺𝗮𝗷𝗼𝗿 𝗼𝘃𝗲𝗿𝗵𝗮𝘂𝗹 of the QSIT! 🏥💉 "FDA intends to replace its current inspection approach for medical devices, QSIT, with an inspection approach that will be consistent with the requirements of the QMSR." 💡 Although no real detail on timing or content, FDA is working on the revision to the QSIT and also assessing the impact of the QMSR on the MDSAP. ⏳ "FDA intends to engage in a variety of implementation activities, including: ✅ Training of personnel ✅ Finalizing the inspection approach ✅ Updating information technology systems ✅ Assessing regulations and documents impacted by this rule." ❓Question: Since the current QSIT came about 3 years after the QSR, do you think the QSIT "2.0" will also take 3 years (2026+3=2029 😳)❓ ~~~ If you found this interesting or helpful, consider Reposting 🔄; follow me Vincent F. Cafiso and click the 🔔 so you don't miss future content.

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Headed to ISPE Delaware Valley Chapter (ISPE DVC)'s annual symposium tomorrow? Swing by Booth 1203 to meet our team and talk through your biggest engineering or automation challenges in #pharmaceuticalmanufacturing. Not only do we want to meet you, we want to enter you to win FREE football tickets! See you tomorrow! #pharma #biopharma #ISPE #knowitbeforeyoubuildit #CQV #processengineering #automation #digitaltransformation

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Headed to ISPE Delaware Valley Chapter (ISPE DVC)'s annual symposium tomorrow? Swing by Booth 1203 to meet our team and talk through your biggest engineering or automation challenges in #pharmaceuticalmanufacturing. Not only do we want to meet you, we want to enter you to win FREE football tickets! See you tomorrow! #pharma #biopharma #ISPE #knowitbeforeyoubuildit #CQV #processengineering #automation #digitaltransformation

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🔍 Navigating device maintenance vs. remanufacturing? The latest FDA guidance sheds light on the differences and regulatory duties. Ensure your medical devices meet safety and quality standards. Want to dive deeper? 📚 Visit www.namsa.com to learn more! #MedicalDevices #FDA #RegulatoryGuidance

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Elevate your wafer surface defect inspection with MSP's new SPx Calibration Standards, designed to calibrate, verify and re-qualify the most common inspection systems. Ensure high yield and quality with NIST-traceable precision. Learn more: https://tsi.news/3WvlWXL #Semiconductor #MSP #DefectInspection #Wafer #Surfscan #CalibrationStandards

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Elevate your wafer surface defect inspection with MSP's new SPx Calibration Standards, designed to calibrate, verify and re-qualify the most common inspection systems. Ensure high yield and quality with NIST-traceable precision. Learn more: https://tsi.news/3WvlWXL #Semiconductor #MSP #DefectInspection #Wafer #Surfscan #CalibrationStandards

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We are #hiring. If you are -- or know of -- a great #NPIProjectManager, take a look at the job description below. #MedicalDeviceManufacturing #ImprovingPatientsLives #NewProductIntroduction #ColoradoProud

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📣 We’ve just released the 2024 Regulatory Readiness & Resources Report based on input from nearly 700 respondents! Sponsored content from Celegence: The survey was sent industry-wide, conducted by RAPS and co-sponsored with Celegence, a RAPS partner. The eye-opening results from this benchmark survey informs future trends and investments for the Life Sciences industry. The results are broken out into two different reports to showcase results from both the Pharmaceutical and Medical Device industries Key findings reveal: ✅ Industry is increasing focus on managing resources, with bandwidth/resources the #1 challenge ✅ 77% in Medical Devices, 55% in Pharma have insufficient resources for all of 2024 priorities ✅ AI early adoption use cases include data extraction, report generation and medical writing 👉 Download your copy today: https://bit.ly/4ehay8v A huge thank you to those who participated and contributed to the survey! #regulatory #regulatoryaffairs #regulatorycompliance

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📣 We’ve just released the 2024 Regulatory Readiness & Resources Report based on input from nearly 700 respondents! Sponsored content from Celegence: The survey was sent industry-wide, conducted by RAPS and co-sponsored with Celegence, a RAPS partner. The eye-opening results from this benchmark survey informs future trends and investments for the Life Sciences industry. The results are broken out into two different reports to showcase results from both the Pharmaceutical and Medical Device industries Key findings reveal: ✅ Industry is increasing focus on managing resources, with bandwidth/resources the #1 challenge ✅ 77% in Medical Devices, 55% in Pharma have insufficient resources for all of 2024 priorities ✅ AI early adoption use cases include data extraction, report generation and medical writing 👉 Download your copy today: https://bit.ly/4ehay8v A huge thank you to those who participated and contributed to the survey! #regulatory #regulatoryaffairs #regulatorycompliance

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📢Sharing an Insightful Report on our LinkedIn - 2024 Regulatory Readiness & Resources📢 Sponsored content from Celegence: Together with Regulatory Affairs Professionals Society (RAPS), Celegence, a renowned RAPS partner, conducted a comprehensive survey gathering valuable insights from almost 700 respondents across the Life Sciences industry. The findings of this benchmark study will help shape future trends and investments. 📑The survey results are presented in two reports showcasing the Pharmaceutical and Medical Device sectors. 🔑Key Takeaways: 💼 #LifeSciences industry is ramping up efforts in resource management, with bandwidth/resources as the top challenge. 🚨 77% in the #MedicalDevices sector and 55% in Pharma report insufficient resources for their 2024 priorities. 🤖 AI early adoption use cases involve data extraction, report generation, and medical writing. Don't miss out on valuable insights that can impact the future of the Life Sciences industry! https://bit.ly/4ewPQl2

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Identify and eliminate recurring errors efficiently with SECA's precise root cause analysis and get suggestive & actionable CAPAs. Simplify your investigative process and ensure consistent improvement with SECA's user-friendly interface, empowering your team to tackle issues head-on and maintain operational excellence. Streamline your error management and enhance your QMS with SECA! #innovation #technology #investigations #linkedin

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It seems like many of the activities and meetings associated with the various parts of the CHIPS Program slowed down over the summer of 2023, but that is changing rapidly as we enter the fall. Recently there have been two announcements that may be of interest to a number of NextFlex members. Check out our newest blog post below to read about NextFlex's update on the Chips Program #Chips #manufacturing #semiconductor #flexiblehybridelectronics #technology https://lnkd.in/giP_AFVg

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We are here to help you create your Quality Plan for the transition from the QS Regulation to the QMSR. Darren Reeves discusses what that should include in this DP Minute.

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Cadence, Inc. is running in the #ContractManufacturing category of this year's MDO Leadership in #MedTech. You can vote for Cadence, Inc., HERE: https://lnkd.in/eT4BmtBJ #PlasticManufacturing #MedicalDevices #InjectionMolding #OEM #MedicalDiagnostics

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Webinar coming soon on May 7 on the important topic of Medical Device Packaging Seal Quality. Don't miss this opportunity to learn about the latest advancements in seal inspection! Register today! Webinar will be recorded for those who cannot attend live. #PTI #webinar #medicaldevice #sealquality

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Hard work doesn't guarantee success, but it improves the chances! 💪 Shoutout to Grethel Cristhina Cabuto for sharing this powerful quote. Grethel is an OpEx Manager and Industrial Engineer with 10 years of experience in BioTech, Aerospace Defense, Automotive & PPE/Medical Devices Industries. IF there is one common theme amongst successful women in STEM, it's hard work and determination! Read dozens of stories and gain insight and inspiration in Extraordinary Engineers: Volume 2, available on Amazon, at Barnes & Noble, and most places books are sold! #extraordinaryengineers #engineers #womeninSTEM #STEM

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