Sterigenics’ Post

🔊 Exciting News! 🔊   James Drinkwater, Head of GMP compliance at Franz Ziel GmbH, in collaboration with Di Morris, PNR Pharma / ex-MHRA, who were co leads of the PHSS Annex 1 commenting platform, have produced an insightful article on protective airflow applied in aseptic manufacturing. The article explores the nuances and critical role that protective airflow provides in preventing critical surfaces and sterile products from airborne contamination.   🌬️The article underscores the critical role of protective airflow, notably First Air in protecting sterile products from contamination in aseptic manufacturing, focussing on GMP compliance and the 2023 revision of Annex 1. It advocates Computational Fluid Dynamics (CFD) analyses to understand airflow dynamics, emphasizes the distinction between airflow patterns in protecting open containers during aseptic filling, and highlights the need for improved design and monitoring to align with the revised standards and ensure product quality and patient safety.   💡Check out the article for valuable insights into this critical aspect of our industry: https://lnkd.in/eeyU3y_V   #AsepticManufacturing #ProtectiveAirflow #FirstAir #fz #franzziel #protectinglifewithtechnology

Thank you Manuel Grandy for putting together a clear explication of this critical point - I agree with your general argument and am just as concerned with this potential change in practice. As practitioners with accumulated experience of many processes, we have the correct intuition that the traditional overkill method frequently significantly overachieves on the SAL target. However, this change of practice 𝐢𝐬 𝐧𝐨𝐭 an appropriate optimization, if it does not also acquire additional product- & process-specific data to prove its implicit assumptions about bioburden resistance & distribution. I would quibble a bit with some of the concern on day to day bioburden variability, since that seems to cast doubt on other established bioburden-based methods (such as all available methods for radiation sterilization). Sterilization is ultimately a statistical process, and achieving SAL of 10^-6 nominally does mean that different sub-quantities can technically have higher (and lower!) SAL while still meeting the ultimate goal. (Obviously if you have highly variable bioburden then non-overkill methods need to be carefully justified).

🚨 Important Update on Novel EO Sterilization Validation Approach 🚨 To medical device manufacturers dealing with EO sterilization: Today, we bring to your attention a video that critically examines the novel approach to EO sterilization validation which is 😌 instead of demonstrating the SAL based on a meaningful and reliable kill rate at the most challenging location of the device 😧 rather relying on product tests of sterility without calculating a meaningful kill rate.   Our discussion, backed by experts from industry and regulatory bodies, highlights concerns about its statistical reliability, potentially impacting regulatory acceptance and the sterility of medical devices. Key Points: ☝Regulatory Challenges: Why this method might not be accepted by regulatory bodies. ☝Risk of Unsterility: The potential increase in unsterile products if adopted globally.   👀 Watch the video below to understand the implications and join the conversation. We encourage you to watch the entire video, but if you're short on time and just want an insight, please skip ahead to minute 20:15. Your perspective is critical to shaping future standards. Let’s ensure our practices safeguard patient health and comply with regulatory expectations. Many thanks in advance for an engaging conversation!   https://lnkd.in/eXwKzstY   #MedicalDevices #Sterilization #EOsterilization #ISO11135 #ISO #HealthcareSafety [1] ISO/DIS 11135.2:2023 (https://lnkd.in/eynhvPsg), i.a. Annex B4. [2] Fundamentals of Sustainable EO® Sterilization at #steris website or https://lnkd.in/ek8W73u3

🚨 Important Update on Novel EO Sterilization Validation Approach 🚨 To medical device manufacturers dealing with EO sterilization: Today, we bring to your attention a video that critically examines the novel approach to EO sterilization validation which is 😌 instead of demonstrating the SAL based on a meaningful and reliable kill rate at the most challenging location of the device 😧 rather relying on product tests of sterility without calculating a meaningful kill rate.   Our discussion, backed by experts from industry and regulatory bodies, highlights concerns about its statistical reliability, potentially impacting regulatory acceptance and the sterility of medical devices. Key Points: ☝Regulatory Challenges: Why this method might not be accepted by regulatory bodies. ☝Risk of Unsterility: The potential increase in unsterile products if adopted globally.   👀 Watch the embedded video below to understand the implications and join the conversation. We encourage you to watch the entire video, but if you're short on time and just want an insight, please skip ahead to minute 20:15. Your perspective is critical to shaping future standards. Let’s ensure our practices safeguard patient health and comply with regulatory expectations. Many thanks in advance for an engaging conversation! SteriComp GmbH   https://lnkd.in/eXzwtXj3   #MedicalDevices #Sterilization #EOsterilization #ISO11135 #ISO #HealthcareSafety [1] ISO/DIS 11135.2:2023 (https://lnkd.in/eC4ggzFF), i.a. Annex B4. [2] Fundamentals of Sustainable EO® Sterilization at #steris website or https://lnkd.in/e6SPE8-H

❗💥 For my network working with EO sterilization please take a few minutes for this critical overview of the new guideline approach below!

Interesting discussion on establishing appropriateness of a PCD. If you just want an overview of the arguments jump to 12:06. Thanks for sharing this Manuel!

This issue can be easily solved by migration to the proven and effective use of Chlorine Dioxide gas. While at Amgen and at Eli Lilly we pulished articles on its use, using standard biological indicators to prove 10^-6 level sterility in a variety of settings. Since CD gas concentration can be measured in real time, using a simple and easily available sampling spectrophotometer unit, this solves the question being asked of Ethylene Oxide. CS gas is also operationally non-explosive and also non carcinodenic. The often quoted (by the providers of other technologies) and misleading EPA table on its relative impact on materials was not performed using the concentrations used in actual sterilization of pharmaceutical components or equipment, which is siginficantly lower.

Best Guide for Ensuring Cleanroom integrity, Strategies for Preventing Microbial Contamination Free Downladoable in #Pharma and #medical resources courses and events #group ⬇️⬇️⬇️ https://lnkd.in/eUXFKGY2

#Microbiological testing in the production of #medicaldevices 💉 Meticulous implementation of microbiological #testing during the manufacturing process is vital to ensure that #medical devices are safe and effective. Medical #devices are indispensable tools for the #diagnosis and treatment of various health conditions and affections. It is very important to identify possible sources of microbiological contamination and assess their risk to patients. 👉 https://lnkd.in/deQsJJ-E Types of microbiological tests 🔬 #Sterility testing: ensures that medical devices are free of live microorganisms.  🧫 #Bioburden testing: establishes a baseline level of microbiological contamination in a device and evaluates the effectiveness of sterilization processes. 🦠 Bacterial #endotoxin testing: verifies that the devices do not contain harmful levels of #endotoxins. #microbiologicaltesting #sterilitytesting #bioburdentesting #endotoxintesting #qualityassurance #regulatorycompliance #medicaldevicesmanufacturing Mauren Monge Mora Roberto Avila LuisMiguel Solano Luis Diego Gutiérrez Herrera Hector Coward Ugalde Andres Villalobos David Solórzano Arias