groninger Group

As the year 2024 draws to a close, we would like to take this opportunity to express our heartfelt thanks. It has been a tremendous pleasure to accompany you this year. Your trust and cooperation mean a great deal to us.   We wish you and your family a Wonderful Holiday Season and a Happy New Year. May 2025 bring you health, happiness, and success.   We look forward to celebrating new achievements with you in the coming year. #WefillVisions #groninger #MerryChristmas #FroheWeihnachten

As the year 2024 draws to a close, we would like to take this opportunity to express our heartfelt thanks. It has been a tremendous pleasure to accompany you this year. Your trust and cooperation mean a great deal to us.   We wish you and your family a Wonderful Holiday Season and a Happy New Year. May 2025 bring you health, happiness, and success.   We look forward to celebrating new achievements with you in the coming year. #WefillVisions #groninger #MerryChristmas #FroheWeihnachten

H₂O₂ decontamination is a reliable method to ensure sterility during the transfer of RTU (ready-to-use) containers into grade A zones. ✔️   In this process, the packaging materials are exposed to vapor phase hydrogen peroxide (VPHP) in a controlled chamber, where temperature, humidity, and H₂O₂ concentration are carefully managed. The H₂O₂ works by forming free radicals that disrupt and destroy microorganisms, ensuring complete surface decontamination. After a set dwell time, the chamber is aerated to reduce residual H₂O₂ to safe levels (e.g., below 1 ppm), allowing the containers to move into the grade A zone.   The process is easy to validate, achieving a 6-log reduction in microorganisms, and is ideal for small-batch applications. However, challenges include managing residual H₂O₂, i.e. outgassing from polymer materials, limited processing speed, and ensuring operator safety.   Benefits: 🔵 Easy to Validate: Proven 6-log reduction in microorganisms. 🔵 Simplified Contamination Control: In-line decontamination is easy to manage. 🔵 Ideal for Small Batches: Suited for high-quality, small-scale applications.   Challenges: ⚪️ Residual H₂O₂: Must be carefully aerated to avoid unsafe exposure levels. ⚪️ Outgassing: Some materials may degrade when exposed to H₂O₂. ⚪️ Operator Safety: Careful protection is needed to prevent exposure to H₂O₂ vapors.   In conclusion, H₂O₂ surface decontamination is an efficient and easy-to-validate method for a safe transfer of RTU materials to grade A for low to medium speed applications. #PharmaceuticalIndustry #PharmaceuticalManufacturing #AsepticFilling #AsepticTransfer #H2O2Decontamination

🎄 Doing Good Together: Our Christmas Tradition at groninger At groninger, we’ve embraced a meaningful Christmas tradition: instead of giving presents, we donate to important causes. This year, we’re proud to support three remarkable organizations: 🌟 The Crailsheim Clinic 🌟 The Children's hospice Schwäbisch Hall 🌟 The Rainforest Alliance These initiatives reflect our commitment to both local and global communities. Now, we invite you to join us in making an impact! Vote for your favorite project, and we’ll divide our donations based on your votes. Rest assured, every organization will receive a share – because no one should go away empty-handed. Let’s spread kindness and make a difference this holiday season. 💚

FAT for RTU vial filling line for our partner #GSKBelgium – Check!   We are thrilled to announce the successful Factory Acceptance Test (FAT) for an RTU vial line for GSK's site in Wavre, Belgium. This marks a significant milestone for GSK, as it is the first of two high-speed lines designed to deliver 400 vials per minute, all with 100% in-process control. The line combines state-of-the-art technology with innovative processes – this makes it one (or two 😉) of a kind! This achievement wouldn't have been possible without the exceptional collaborative spirit we share with our valued partner, GSK. Their trust and commitment to innovation have been a driving force behind this project! We are proud to support you to always be #AheadTogether. As Christmas time is coming we cannot await to see this beauty be installed and combined with the GEA Group Freeze Dryers and SKAN Isolators at Wavre site in 2025.   Thank you to the whole GSK and groninger team involved for making this project a true success story! #PharmaceuticalIndustry #PharmaceuticalManufacturing #Collaboration #Innovation

Are you ready to navigate the complexities of Annex 1? 💡 Join us to deepen your understanding of key regulatory changes and enhance your strategies for sterile production. Together with experts from groninger Group and Körber Pharma, we’ll provide actionable insights into sterile manufacturing compliance under the new Annex 1 guidelines

Broad-spectrum pulsed light can decontaminate RTU containers without residue and reduced complexity – Curious how it works? 👇 The process begins with the removal of the wrapping (bag) from RTU containers, which are then introduced into the decontamination section under laminar airflow. Here, they are exposed to short, intense flashes of broad-spectrum white light (200–1100 nm) from a xenon lamp, which includes 15% UV-C, 50% visible light, and 35% near IR. The UV-C light, particularly in the 100–280 nm range, disrupts the DNA and proteins of microorganisms through two mechanisms: + Photothermal Effect: Heat from the light flash causes microorganisms to rupture. + Photochemical Effect: The UV-C light alters the molecular structure of DNA and proteins, rendering pathogens inactive. This combination of effects ensures the destruction of a wide range of microorganisms, including bacteria, viruses, fungi, and spores, before the containers move to the grade A zone for further processing. Key Benefits: ✔️ No Residuals: UV-light leaves no chemical residues, unlike methods like ethylene oxide or steam sterilization. ✔️ Simple Technology: Compared to other decontamination processes, UV-light is straightforward, reducing complexity and cost. ✔️ Compact Design: The system’s small footprint is ideal for small-batch production or environments with limited space. ✔️ Grade Transfer from C to A: Ensures aseptic conditions during the transfer from lower grade zones (e.g., C) to critical grade A areas. Challenges: 🟥 Limited Log Reduction with Conventional BIs: UV-light typically achieves a 4-log reduction with standard biological indicators (BIs), but a 6-log reduction can be validated through spray inoculation. 🟥 Processing Speed: UV-light decontamination is not as fast as other technologies, making it less suitable for high-speed operations. 🟥 Shadowing Effect: Areas of containers in shadow may not be fully exposed to UV-C light, requiring careful validation to ensure complete sterilization. UV-light decontamination offers a simple, chemical-free, and effective solution for ensuring aseptic transfers in pharmaceutical manufacturing. By adhering to Annex 1’s sterility requirements, it ensures sterility while supporting efficient, low-residue processes. However, careful validation is required to address challenges like the shadowing effect and log reduction. #PharmaceuticalIndustry #PharmaceuticalManufacturing #AsepticFilling #AsepticTransfer #Annex1 #Decontamination #UVLightDecontamination

How an E-Beam can support Annex 1 Compliance 👇 E-Beam sterilization operates through a high-energy electron beam to target microorganisms at the DNA level, ensuring complete sterility. First, the tub is de-bagged under laminar flow. Here, the single bag is removed before the tub is transferred to the infeed section of the E-Beam. The process is performed in a closed chamber. Two or three emitters deliver precise electron beams that destroy the DNA of all pathogens, including viruses, bacteria, fungi and spores. E-Beam sterilization is a perfect match for the requirements of Annex 1 because it adheres to the validated sterilization standards set by ISO 11137. The process guarantees a 6-log reduction of microorganisms, ensuring that RTU containers are sterile before they enter the critical grade A zones for aseptic filling or other operations. This method reduces risks associated with cross-contamination while maintaining high throughput, an essential requirement for fast-paced production environments. Key Benefits: ➕Easy-to-Validate Process: Ability to demonstrate a clear 6-log reduction in resistant microorganisms ➕ Seamless Grade Transfer: Grade transfer from C to A ➕ Reduced Contamination Risk: Simplified contamination control strategy through in-line decontamination management ➕ High-Speed Processing: Rapid processing capabilities make it ideal for high-volume manufacturing, allowing continuous and quick sterilization.   Challenges to Consider: ➖ Increased Line Complexity: In-line decontamination process increases line complexity and may impact building construction. ➖ Protection and Safety Officers: Requires personal protective equipment and health and safety officers to ensure compliance with safety standards. ➖ Radiation Safety: Essential measures are needed to protect personnel from radiation, including shielding and monitoring. ➖ Free Radicals and/or Ozone Risks: These by-products pose health risks, necessitating careful management and mitigation strategies. E-Beam sterilization presents a powerful solution for meeting Annex 1's stringent requirements while providing a reliable and efficient method for aseptic transfer. However, attention to safety measures and system design is essential to mitigate potential challenges. Sounds interesting to you? Get in touch with us 🌟 #Annex1 #AsepticTransfer #PharmaceuticalIndustry #PharmaceuticalManufacturing #FillFinish #AsepticFilling

🌏 After three incredible days at CPHI & PMEC India in Delhi 🇮🇳, we are wrapping up our time at the event with a heart full of gratitude. Together with our partner, ACE Technologies Group, we had the pleasure of showcasing groninger's advanced Fill and Finish solutions tailored to the pharmaceutical industry. 🌟   The event gave us the opportunity to engage in inspiring conversations, meet amazing people, and discuss how our innovations can help shape the future of pharma production. Your enthusiasm and curiosity have been truly energizing!   To all our visitors – thank you for stopping by our booth, sharing your ideas, and exploring collaboration opportunities with us.   📩 Let’s stay connected! If you’d like to learn more about our solutions, feel free to reach out to us directly or connect with our local partner, ACE Technologies. Together, we are here to bring your pharma projects to life!   #PMECIndia #CPHIIndia #PharmaInnovation #FillAndFinish #PharmaceuticalManufacturing #PharmaceuticalIndustry

Successful FAT in Crailsheim with Klosterfrau Berlin GmbH! ✔️   We are delighted to look back on the successful Factory Acceptance Test (FAT) of our innovative filling and closing machine from Klosterfrau Berlin GmbH based in Berlin! This state-of-the-art line enables the filling of products ranging from liquid to highly viscous, offering outstanding flexibility. The optimized process - from syringe siliconization and precise filling to efficient plunger assembly and labelling - ensures the highest quality standards.   The line is flexible and adapts to different scenarios, further enhancing efficiency in contract manufacturing. We are proud to support Klosterfrau in the development of high-quality products.   A big thank you to everyone involved for the excellent collaboration! 💚   #groninger #Klosterfrau #Farco #syringefilling #FAT #innovation #pharma