groninger Group

From Clinical Phase to Commercial Production: Overcoming Challenges! In the pharmaceutical industry, the transition from clinical development to commercial production is often full of challenges. Production managers not only face increasing demands but must also ensure that their processes remain efficient and flexible. 💡 🔑 The solution: Our flexfill machine concept. ➡️ With a production output of up to 12,000 objects per hour and a shortened qualification process, we provide a way to significantly reduce your time-to-market – all while maintaining high quality standards. At groninger, we're here to help accelerate your entire production process and take it to the next level. 📈 #pharmaceuticalindustry #pharmaceuticals #groninger #flexfill #pharmaindustry 

Are you ready to navigate the complexities of #Annex 1? 💡   Together with Franz Ziel GmbH, partner of Körber Pharma, and our local expert, Matt Clifton, we’ll provide actionable insights into sterile manufacturing compliance under the new Annex 1 guidelines during an exclusive on-site seminar from January 21 to 22.   Join us to deepen your understanding of key regulatory changes and enhance your strategies for sterile production. From aseptic filling and containment concepts to the latest regulatory guidelines, our seminar is tailored to address the challenges that matter most.   Seats are limited, secure your spot today and let’s tackle Annex 1 together!  👉 https://lnkd.in/eXdMAfHV

✨ We are thrilled to announce the successful Site Acceptance Test (SAT) of our vial line and flexfill RTU syringe filling machine at Anthea, one of the most dynamic and growing CDMO and CMO companies in India. This milestone marks another significant achievement for Anthea Pharma 🇮🇳 as they continue to expand their capabilities to meet the increasing global demand for high-quality pharmaceutical products. 🚀   A huge thank you to the incredible teams at Anthea and ACE Technologies Group for their outstanding collaboration and mutual support throughout the project. Together, we’ve achieved a seamless implementation of this cutting-edge technology, setting a new standard for flexibility, speed, and reliability in pharmaceutical manufacturing. 🛠️   We are proud to partner with innovative companies like Anthea, who are not only advancing in technology but also shaping the future of pharmaceutical manufacturing in India and beyond.   Looking to speed up your production? Contact us to learn more about how #flexfill can help!   #pharmaceuticals #flexfill #pharmamanufacturing #collaboration #CDMO

Overview of Aseptic Transfer of RTU Containers in Light of Annex 1   With Annex 1 becoming effective, there are expanded requirements for introducing RTU primary packaging materials into the aseptic process zone (grade A). This critical step aims to minimize the risk of contamination and is precisely described in various sections of Annex 1.📜   🔎 Regulatory Highlights: 📌 4.10: The transfer of equipment and materials into and out of cleanrooms and critical zones is a major contamination risk. 📌 4.11: Transfers into grade A or B areas should follow a unidirectional process and should include a sterilization step if possible. If sterilization is not feasible, validated procedures to prevent contamination must be used. 📌 8.47: Sterilized items in sealed packaging should be transferred into grade A using validated methods like airlocks, with effective exterior disinfection. 📌 8.48: Packaging for sterilized items must minimize contamination risks and be compatible with the sterilization method. The sealing process should be validated to ensure the integrity of the sterile barrier.   There are several methods to achieve this goal, each with its own set of advantages and challenges. Here are the four main methods we will be discussing in detail: 🔹 NTT (No-Touch-Transfer) 🔹 E-Beam Sterilization 🔹 UV Pulsed Light Surface Decontamination 🔹 H2O2 Surface Decontamination   👉 In the following posts, we will dive deeper into each method, discussing their respective pros and cons. Stay tuned to learn about the best practices and innovative approaches in aseptic processing. 📢 #PharmaceuticalIndustry #PharmaceuticalManufacturing #Annex1 #AsepticTransfer #ContaminationControl

PACK EXPO 2024 in Chicago was an incredible success! A heartfelt thank you to everyone who visited us and to our amazing team who made it all happen! 🌟 Engaging with each of you and showcasing our innovations was truly inspiring. #packexpo2024 #fillfinish #thankyou

We are excited to share that Julian Petersen has been elected to the Steering Committee of the ISPE Community of Practice for Sterile Products Processing! 🎉 The ISPE Community of Practice is a global network of professionals, including manufacturers, vendors, and consultants, all dedicated to improving the quality and safety of sterile pharmaceutical products. This community addresses critical topics such as drug shortages, robotics in manufacturing, risk-based quality systems, barrier systems, single-use solutions, environmental monitoring, and the impacts of #Annex 1. Recently, discussions have expanded to include compounding pharmacies and advanced treatments like cell and gene therapy and combination devices. We are proud to be part of this community. 💚

🕵♀️ Looking for a great new job? 🕵 Then meet our team this weekend at the Fachkräftetage in the Arena Hohenlohe in Ilshofen. There you can find out more about your entry opportunities at groninger. No matter what career level you're at. We are looking forward to meeting you! 😊 Already other plans? Find the right job on our career website: https://lnkd.in/d-xh_rFq #groninger #fachkräftetage #ilshofen #arenahohenlohe #arenailshofen #jobmesse

Enhancing liquid pharmaceutical development 🔬 In the research and development of liquid pharmaceutical products, the filling process plays a crucial role. This process must meet the stringent requirements of customers and authorities like the FDA, while also accommodating specific product properties that influence the choice of primary packaging materials. Our semi-automatic tabletop system is designed to address these challenges effectively. By using the same technology and processing methods as high-speed groninger machines, the labworx series ensures that insights and data gained during development can be seamlessly scaled up to larger volumes. This capability is vital for maintaining consistency and efficiency throughout the drug development process. #Pharmaceuticals #DrugDevelopment #Innovation #FDACompliance

Visit us at PACK EXPO 2024 in Chicago! 🙌 Meet us at this year's PACK EXPO at booth W-17023. Come and discuss all your fill-finish needs with our team of experts. We're here to help and look forward to meeting you in person! Don't miss this opportunity to connect with us. 💚

groninger recently welcomed Grand River Aseptic Manufacturing to our site in Crailsheim Germany for a mock-up. groninger and SKAN collaborated together for GRAM’s newest filling line that will increase their syringe and cartridge processing capabilities.    An in-person mock-up is a great opportunity to meet the teams and offers a first-hand look at locating critical components within a filler/isolator, how operators can access the line via glove ports, addressing filling path needs and RTP locations.     Since groninger is currently assembling multiple filling lines of this type, the team had the benefit to compare and leverage the real machine with the mock-up model in parallel and test the handling.   This new line is capable of processing RTU components with fully automatic debagging of the inner and outer bag. All objects are removed from the nest for processing and components are 100% IPC checked. Stoppers are inspected for presence and placement within the syringe barrel. All rejected components are removed on the line prior to components being placed back into the nested tub.    We are grateful for our partnership and look forward to the next stages of the project!   #pharma #fillfinish #partnership