ISPE D/A/CH

Smoke Studies – Not at all easy! The ISPE D/A/CH CoP Aseptic Processing Steering Committee recently discussed feedback on smoke studies from recent FDA inspections during their January meeting. These "smoke studies" are commonly performed for airflow visualizations according to Annex 1 (2022). Recent FDA inspections have raised questions about the type of "smoke" used. Historically, alcoholic aerosols were favored for their visibility, making them ideal for studying airflow visualizations at equipment or during manual interventions, including operator training. However, many companies have switched to WfI vapor to avoid surface residues. Inspectors now seem to prefer alcoholic aerosols over WfI due to their better visibility, persistence, and neutral floating behavior. This has prompted studies comparing different aerosols. Airflow visualization will be a key topic at the CoP Aseptic Processing’s Annex 1 seminar later this year. The seminar will cover various visualization techniques and experiences with regulatory agencies, among other topics related to cleanroom quality and appropriate technologies. Follow ISPE D/A/CH’s social media channels for more details on the seminar, which will be available starting in March.

*Save the Date* for the next event in the Women in Pharma ISPE D/A/CH Workshop series: Challenge Your Mindset. This exclusive workshop is designed for senior management and C-suite professionals, focusing on the crucial topic: Navigating Change in a Diverse World. Join us for an engaging and insightful experience where industry leaders will share their expertise and strategies for managing change in today's diverse and dynamic environment. This is a unique opportunity to network with peers, gain valuable insights, and enhance your leadership skills. 🗓️ Date: June 2-3, 2025 📍 Location: Roche, Penzberg Stay tuned for more details, including our lineup of speakers and the full agenda. Don't miss out on this chance to challenge your mindset and drive positive change within your organization! #WomenInPharma #Leadership #Diversity #ChangeManagement #ISPE #Networking #ProfessionalDevelopment

⭐️ Introducing the ISPE D/A/CH Working Group “Cleanroom Quality and CCS” ⭐️ Aseptic manufacturing is one of the most demanding areas in pharmaceutical production. Ensuring sterility, maintaining cleanroom integrity, and navigating ever-evolving regulations require a strong, knowledgeable community. That’s why we are thrilled to introduce the newly founded ISPE D/A/CH Working Group, “Cleanroom Quality and CCS.” Our mission? To drive excellence in contamination control, aseptic behavior, and environmental monitoring. Together, we tackle a few of the biggest challenges in aseptic processing by focusing on five key areas: 🔹 Contamination Control Strategy (CCS) – Building holistic, science-based, risk-driven approaches to contamination prevention. 🔹 Aseptic Process Simulation (APS) – Strengthening sterility assurance through well-defined process simulations. 🔹 Aseptic Behavior & Interventions – Defining best practices for operators to minimize contamination risk. 🔹 Cleanroom Monitoring (RRM) – Optimizing cleanroom monitoring strategies for compliance and efficiency. 🔹 Environmental Monitoring (EM) – Improving viable and non-viable particle monitoring for greater process understanding. By fostering collaboration across industries, we aim to shape the future of aseptic processing through knowledge-sharing, regulatory discussions, and industry-driven solutions. We invite you to join us! Your expertise, whether from pharmaceutical manufacturing, academia, consulting, or equipment development, is invaluable. Let’s drive innovation in aseptic processing together. #AsepticProcessing #CleanroomQuality #ContaminationControl #EnvironmentalMonitoring #ISPE #Pharma #SterileManufacturing

🌟 Save the Date! 🌟 Join us for the "Industry meets Women in Pharma" event, proudly sponsored by Vetter Pharma, on May 22 in Ravensburg. The day will kick off with insightful site visits, followed by a workshop and presentations focused on empowerment. Hear from industry leaders and experts as they share their knowledge and experiences. Don't miss this incredible opportunity to connect, learn, and be inspired. Mark your calendars and stay tuned for more details! #WomenInPharma #Empowerment #Networking #VetterPharma #IndustryMeetsWomen

🌟New Event Series🌟 The CoP Project Management is launching a new offline event series and we are looking for enthusiastic hosts in Basel to join us! This series is designed to be an engaging evening filled with insightful presentations, dynamic discussions, and valuable networking opportunities. It's all about diving deep into technical topics and sharing knowledge within our community. 📅 Event Details: Frequency: Quarterly Day: Tuesdays Time: 18:00 - 20:00 Interested in hosting? Reach out to us for more details! #ProjectManagement #Networking #AI #Engineering #Automation #CommunityEvent #Basel

We are excited to present a recap of the ISPE Future Leaders Days 2024 held last November at Boehringer Ingelheim. This event featured insightful talks, interactive networking, and an exclusive look behind the scenes of the pharmaceutical industry. Watch the video for all the highlights and impressions from the event. Stay tuned for updates on this year's event. #FLD2025 If your company is interested in sponsoring or hosting, please contact us for more information. https://lnkd.in/dgRFFygA

➡️ Shaping the Future of Pharmaceutical Sterility Standards The pharmaceutical industry continuously faces the challenge of improving sterility standards. A key aspect of this is the process for installing pre-sterilized stopper contact parts. What could this process look like in the future? The development of best practices will not only improve the quality and safety of our products but also ensure compliance with the latest regulations. Our subgroup, "Appropriate Technologies," is focusing on the following aspects: 🔹 First-Air Principles 🔹 Design 🔹 Interventions 🔹 Pragmatic Handling 🔹 Feasibility 🔹 Cost-effectiveness In our ISPE COP working group, we look forward to your intensive participation in our constructive discussions and the exchange of experiences from the industry. Let's shape the future of pharmaceutical production together! Post your thoughts below! 👇 #Asepticprocessing #ISPEDACH

We are proud to have partnered with Boehringer Ingelheim for the ISPE Future Leaders Days in 2024. Their sponsorship played a key role in the event's success. If you are interested in sponsoring or hosting the next ISPE Future Leaders Days for future leaders and experts in the pharmaceutical industry, please reach out to us. #ispefld2025 #FutureLeadersDays #ispe

📌 Introduction of our subgroup Appropriate Technologies 📌 "Appropriate Technologies" is a subgroup of the COP 'Aseptic Processing' within ISPE DACH that is well-connected in the Pharmaceutical industry and collaborating with other ISPE groups and various organizations. 1) We are a group of engineers and technicians with extensive experience in operating, planning, and constructing aseptic filling facilities. We provide a discussion platform to share knowledge, latest developments and best practices in the D/A/CH region. 2) Through themed workshops, expert discussions, and effective communication, we develop best practice papers and procedures. A key objective is to incorporate dialogue with regulatory representatives into our discussions, as well as to provide interpretative guidance on regulatory frameworks. 3) Our strong network allows us to drive innovation and compliance in aseptic processing. #Asepticprocessing #ISPEDACH

➡️ Call for Digital Use Case Submissions! For the upcoming ISPE D/A/CH Workshop “Pharma’s Journey to Digital Manufacturing and Supply” in Basel, September 15-17, 2025, we are looking for digital use cases to be featured in the workshop. Why submit your use case? 🌟 Showcase Your Innovations: This is your chance to present your digital solutions to a diverse audience of industry experts and health authority representatives. Highlight your successes and share your learnings with peers who are equally passionate about digital transformation. 🌟 Gain Recognition: By submitting your use case, you position yourself and your organization as leaders in the field of digital transformation. Gain recognition for your innovative approaches and contribute to the advancement of the pharmaceutical and biotech sectors. 🌟 Collaborate and Learn: Engage in meaningful discussions with seasoned experts in data science, GxP, technology transfer, management, quality, and regulatory affairs. Learn from their experiences and insights, and collaborate on finding solutions to common challenges. 🌟 Drive Industry Progress: Your contributions will help shape the future of digital manufacturing and supply in the pharma and biotech industries. Be a part of the movement that drives progress and innovation. Don't miss this opportunity to showcase your digital solutions and contribute to the future of pharma and biotech! Submit your use case by April 4, 2025, by filling out this form: https://lnkd.in/dmN9d6tw #DigitalTransformation #Pharma #Biotech #ISPEDACH #Innovation #CallForPapers