Titelbild von Eurofins BioPharma Product Testing SwitzerlandEurofins BioPharma Product Testing Switzerland
Eurofins BioPharma Product Testing Switzerland

Eurofins BioPharma Product Testing Switzerland

Arzneimittelherstellung

Schönenwerd, Solothurn 989 Follower:innen

We are testing for life

Info

From Starting Materials through to Finished Product Testing, Eurofins BioPharma Product Testing’s network of over 40 facilities in more than 20 countries delivers the world’s most comprehensive scope of harmonised GMP testing services and seamless regulatory acceptance. As we have grown to become the world’s largest network of GMP product testing labs, we continue to uphold our founding promise of personal service and impeccable quality. Eurofins BioPharma Product Testing Switzerland supports the Swiss BioPharmaceutical Industry with a broad range of GMP services across the global Eurofins service scope. We support the full Eurofins GMP Testing Portfolio for Swiss Clients, and ensure access to all services as one-stop-shop. Highly flexible service models, commited customer service and state-of-the-art IT-process integration round our services up.

Website
www.eurofins.ch/bpt
Branche
Arzneimittelherstellung
Größe
51–200 Beschäftigte
Hauptsitz
Schönenwerd, Solothurn
Art
Kapitalgesellschaft (AG, GmbH, UG etc.)
Spezialgebiete
GMP, Pharma, Microbiology, Water, Purified Water, Water for Injections, Bioburden, TOC, Endotoxin, TAMC, TYMC, Validation, Environmental Monitoring, Utility Monitoring, Annex 1, Contamination Control Strategy, Microbial Identification, Continer Closure Integrity Testing, Extractables & Leachables, Stability, Dissolution, Chromatography, Reference Standards, Particle Testing, Solid State Characterization, Nitrosamines und Raw Materials

Orte

Beschäftigte von Eurofins BioPharma Product Testing Switzerland

Updates

  • 𝗚𝗿𝗲𝗮𝘁 𝗡𝗲𝘄𝘀 – 𝗪𝗲 𝗮𝗿𝗲 𝗮𝘁𝘁𝗲𝗻𝗱𝗶𝗻𝗴 𝘁𝗵𝗲 𝗦𝘄𝗶𝘀𝘀 𝗕𝗶𝗼𝘁𝗲𝗰𝗵 𝗗𝗮𝘆 ❗ Our team is excited to be part of the #𝘀𝘄𝗶𝘀𝘀𝗯𝗶𝗼𝘁𝗲𝗰𝗵𝗱𝗮𝘆 in Basel – 2 days of insightful discussions and meaningful connections. Meet our representatives Jörg Freudenberger and Shahbaz Arif who are looking forward to engaging conversations and staying up to date with the latest trends.  Let’s discuss further 𝗰𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝗼𝗻 𝗼𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝗶𝗲𝘀 and how our analytical services support your development, quality control and commercialization processes. Thanks for the great organisation Swiss Biotech Association. 𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝘂𝘀 𝘁𝗼 𝘀𝗲𝘁 𝘂𝗽 𝗮 𝗺𝗲𝗲𝘁𝗶𝗻𝗴 ❗ 📧 BioPharma.Switzerland@bpt.eurofinseu.com 🌐 www.eurofins.ch/bpt #swissbiotechday #Conference #GMP #Biotech #Pharma #Eurofins #QualityControl #ProductDevelopment #AnalyticalDevelopment #BioPharma #Innovation #SmallMolecule #LargeMolecule #ProductTesting #LifeScience

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  • 𝗢𝗻𝗲 𝗧𝗲𝗰𝗵𝗻𝗶𝗾𝘂𝗲, 𝗠𝗮𝗻𝘆 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀: 𝗧𝗵𝗲 𝗣𝗼𝘄𝗲𝗿 𝗼𝗳 𝗖𝗵𝗿𝗼𝗺𝗮𝘁𝗼𝗴𝗿𝗮𝗽𝗵𝘆 Chromatography is one of the most 𝘃𝗲𝗿𝘀𝗮𝘁𝗶𝗹𝗲 and 𝗽𝗼𝘄𝗲𝗿𝗳𝘂𝗹 analytical tools in the pharmaceutical industry—crucial for ensuring product quality, patient safety, and regulatory compliance. 𝗔𝘁 𝗘𝘂𝗿𝗼𝗳𝗶𝗻𝘀 𝗣𝗛𝗔𝗦𝗧 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗶𝗻 𝗞𝗼𝗻𝘀𝘁𝗮𝗻𝘇, we provide a comprehensive in-house service using advanced chromatographic techniques to support your product 𝗮𝗰𝗿𝗼𝘀𝘀 𝘁𝗵𝗲 𝗲𝗻𝘁𝗶𝗿𝗲 𝗹𝗶𝗳𝗲𝗰𝘆𝗰𝗹𝗲—from development to routine release and stability monitoring. 𝗪𝗲 𝗼𝗳𝗳𝗲𝗿 𝗲𝘅𝗽𝗲𝗿𝘁𝗶𝘀𝗲 𝗶𝗻 𝗮 𝘄𝗶𝗱𝗲 𝗿𝗮𝗻𝗴𝗲 𝗼𝗳 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀:  ✔️ Impurity Profiling  ✔️ Residual Solvent Analysis  ✔️ Assay of Active Components  ✔️ Ion Analysis  ✔️ Stability Testing  ✔️ Dissolution Testing Our GMP-certified laboratory is equipped with a broad portfolio of 𝗰𝗵𝗿𝗼𝗺𝗮𝘁𝗼𝗴𝗿𝗮𝗽𝗵𝗶𝗰 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗲𝘀—HPLC, UPLC, LC-MS, GC, IC—and a diverse selection of 𝗱𝗲𝘁𝗲𝗰𝘁𝗼𝗿𝘀 including DAD, CAD, ELSD, RI, and FLD. Whether you’re developing a new product or managing commercial production, we tailor our analytical approach to 𝘆𝗼𝘂𝗿 𝘀𝗽𝗲𝗰𝗶𝗳𝗶𝗰 𝗻𝗲𝗲𝗱𝘀. Get in touch with our team to explore how our chromatography expertise supports your processes ❗ 📧 Pharma.Konstanz@bpt.eurofinseu.com 📧 BioPharma.Switzerland@bpt.eurofinseu.com 🌐 https://lnkd.in/ejkA4gnA #Chromatography #HPLC #UPLC #IC #QualityControl #GMP #Pharma #Laboratory

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  • 𝗧𝗵𝗲 𝗥𝗼𝗹𝗲 𝗼𝗳 𝗗𝗶𝘀𝗰𝗿𝗶𝗺𝗶𝗻𝗮𝘁𝗼𝗿𝘆 𝗗𝗶𝘀𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻 𝗶𝗻 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗮𝗻𝗱 𝗤𝗖 ❗ Developing a discriminative dissolution method is essential to ensure product performance and safety during development and as a quality control measure in commercial manufacturing. At Eurofins PHAST Development in Konstanz, our experts support our partners in developing 𝘁𝗮𝗶𝗹𝗼𝗿𝗲𝗱 𝗱𝗶𝘀𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻 𝗺𝗲𝘁𝗵𝗼𝗱𝘀 that meet your needs under GMP conditions. 𝗙𝗼𝗿𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁: ✔️A discriminatory dissolution method distinguishes between good and bad formulations, 𝗼𝗽𝘁𝗶𝗺𝗶𝘇𝗶𝗻𝗴 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗳𝗼𝗿𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻 by selecting the right excipients and refining the manufacturing process during dosage form optimization.  ✔️This method also helps in understanding the 𝗶𝗺𝗽𝗮𝗰𝘁 𝗼𝗳 𝗳𝗼𝗿𝗺𝘂𝗹𝗮𝘁𝗶𝗼𝗻 𝘃𝗮𝗿𝗶𝗮𝗯𝗹𝗲𝘀 such as particle size, polymorphism, and solubility on the dissolution profile. By linking dissolution results with other characterization data, we ensure a robust and effective formulation. 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗖𝗼𝗻𝘁𝗿𝗼𝗹: ✔️By assessing batch-to-batch consistency, a well-developed discriminatory dissolution method serves as a quality control essential, 𝗱𝗲𝘁𝗲𝗰𝘁𝗶𝗻𝗴 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 in formulation and manufacturing processes. It ensures that each batch meets the required quality standards and performs consistently in vivo.  ✔️Additionally, this method helps identifying critical quality attributes (𝗖𝗤𝗔𝘀) and critical process parameters (𝗖𝗣𝗣𝘀) that need to be controlled to maintain product quality. Regular dissolution testing can also monitor the stability of the product over time, ensuring it remains effective throughout its shelf life. The development of discriminatory dissolution methods is 𝗺𝗼𝗿𝗲 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗶𝗻𝗴 than normal dissolution methods as they need to be more sensitive to minor formulation changes, require extensive optimization and validation for in vivo prediction, and follow a comprehensive 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗯𝘆 𝗗𝗲𝘀𝗶𝗴𝗻 (QbD) approach. Contact our team now to guide you through the development process of a discriminatory dissolution method tailored to your requirements ❗ 📧 Pharma.Konstanz@bpt.eurofinseu.com  📧 BioPharma.Switzerland@bpt.eurofinseu.com  🌐 https://lnkd.in/eYt8-ryp #Dissolution #Discriminatory #QualityContrl #Development #Formulation #GMP #Pharma #BioPharma

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  • 𝗦𝘄𝗶𝘀𝘀 𝗖𝗹𝗲𝗮𝗻𝗿𝗼𝗼𝗺 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝘁𝘆 𝗘𝘃𝗲𝗻𝘁 – 𝗗𝗶𝘀𝗰𝘂𝘀𝘀 𝗪𝗶𝘁𝗵 𝗨𝘀 𝗖𝗹𝗲𝗮𝗻𝗶𝗻𝗴 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 ❗ Ensuring an effective and compliant cleaning validation process is a 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝘆𝗲𝘁 𝗰𝗼𝗺𝗽𝗹𝗲𝘅 aspect of pharmaceutical manufacturing. Each facility presents unique challenges that require a tailored approach to contamination control. Regulatory guidelines such as 𝗘𝗨 𝗚𝗠𝗣 𝗔𝗻𝗻𝗲𝘅 𝟭 emphasize the importance of contamination control, making it essential to address key challenges in cleaning validation with a scientific and risk-based approach. Meet our team – Jörg Freudenberger, Patrick Sadri and Shahbaz Arif – at Swiss Cleanroom Concept and find out how we help you address major considerations for your cleaning validation. 𝗞𝗲𝘆 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀: ✅ 𝗗𝗲𝗳𝗶𝗻𝗶𝗻𝗴 𝗥𝗲𝘀𝗶𝗱𝘂𝗲 𝗟𝗶𝗺𝗶𝘁𝘀 – Establishing scientifically justified residue limits remains a critical challenge in cleaning validation. Determining acceptable levels requires expertise in toxicology, manufacturing risks, and regulatory requirements. Factors like cross-contamination risks, solubility, and detection sensitivity add to the complexity, making expert assessment essential. ✅ 𝗦𝗲𝗹𝗲𝗰𝘁𝗶𝗻𝗴 𝘁𝗵𝗲 𝗥𝗶𝗴𝗵𝘁 𝗦𝗮𝗺𝗽𝗹𝗶𝗻𝗴 𝗠𝗲𝘁𝗵𝗼𝗱: 𝗦𝘄𝗮𝗯 𝘃𝘀. 𝗥𝗶𝗻𝘀𝗲 – Identifying the optimal sampling method requires careful consideration. Swab sampling provides precise, localized data for direct contact surfaces but may not reach complex areas like pipes and tanks. Rinse sampling, while effective for broader coverage, lacks precise contamination localization. The challenge lies in balancing accuracy and practicality. ✅ 𝗘𝗻𝘀𝘂𝗿𝗶𝗻𝗴 𝗗𝗶𝘀𝗶𝗻𝗳𝗲𝗰𝘁𝗮𝗻𝘁 𝗘𝗳𝗳𝗶𝗰𝗮𝗰𝘆 – Confirming disinfectants effectively eliminate contaminants without leaving residues is a complex challenge that requires a comprehensive evaluation of factors such as surface compatibility, microbial resistance, and regulatory compliance.  ✅ 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗶𝗻𝗴 𝗮 𝗥𝗼𝘂𝘁𝗶𝗻𝗲 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 – Defining an effective routine monitoring plan is challenging due to the variability in facility layouts, risk levels, and evolving regulatory expectations. Determining monitoring locations, frequency, and analytical methods require a strategic, risk-based approach to ensure continuous compliance, contamination control, and process integrity. Our tailored approach is designed to address the unique challenges of your facility, ensuring a compliant and effective cleaning validation strategy, safeguarding product integrity and maintaining a controlled production environment. 📧 BioPharma.Switzerland@bpt.eurofinseu.com 🌐 www.eurofins.ch/bpt #Cleanroom #CleaningValidation #GMP #SwissCleanRoomCommunity #QualityControl #EnvironmentalMonitoring #UtilityTesting #Pharma #BioPharma

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  • 𝟳 𝗗𝗮𝘆𝘀 𝘁𝗼 𝗚𝗼 — 𝗠𝗲𝗲𝘁 𝗢𝘂𝗿 𝗧𝗲𝗮𝗺 𝗮𝘁 𝘁𝗵𝗲 𝟮𝟴𝘁𝗵 𝗦𝘄𝗶𝘀𝘀 𝗖𝗹𝗲𝗮𝗻𝗿𝗼𝗼𝗺 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝘁𝘆 𝗘𝘃𝗲𝗻𝘁 ❗   We look forward to connecting with industry peers, listening to insightful speeches, and discussing the latest GMP solutions for your production environment.   𝗠𝗲𝗲𝘁 𝗼𝘂𝗿 𝗲𝘅𝗽𝗲𝗿𝘁𝘀 Jörg Freudenberger, Patrick Sadri and Shahbaz Arif to learn how we ensure that your cleanroom stays clean!     𝗪𝗲 𝗼𝗳𝗳𝗲𝗿 𝗰𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲 𝗚𝗠𝗣 𝘁𝗲𝘀𝘁𝗶𝗻𝗴 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀, 𝗶𝗻𝗰𝗹𝘂𝗱𝗶𝗻𝗴:   • Cleanroom Qualification • Water System Qualification • Environmental Monitoring • Utility Testing • Root Cause Investigation • Cleaning Validation • Disinfectant Efficacy Studies ...and much more   From sampling, over transport to analysis - 𝘄𝗲 𝗰𝗼𝘃𝗲𝗿 𝗮𝗹𝗹 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝘀𝘁𝗲𝗽𝘀. A big thank you to Swiss Cleanroom Concept for organizing such a great event! We can’t wait to meet you there. 📅 Event Details: Date: 07 April 2025 Time: 15:30 – 21:40 Location: Pratteln, Switzerland   Contact us now to set up a meeting and to learn more about our cleanroom solutions! 📧 BioPharma.Switzerland@bpt.eurofinseu.com 🌐 https://lnkd.in/emctgpV7 #Cleanroom #GMP #SwissCleanRoomCommunity #QualityControl #EnvironmentalMonitoring #UtilityTesting #Pharma #BioPharma

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  • Eurofins BioPharma Product Testing Switzerland hat dies direkt geteilt

    🌟 This week Eurofins BioPharma Product Testing Switzerland hosted their Extractables & Leachables workshop in collaboration with our expert speakers from Eurofins BioPharma Product Testing Italy! 𝗪𝗼𝗿𝗸𝘀𝗵𝗼𝗽 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗮𝗻𝗱 𝗟𝗲𝗮𝗿𝗻𝗶𝗻𝗴𝘀: ✔️𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀: Adapting to regulatory changes, especially USP <665>; is a major challenge for the pharmaceutical industry. ✔️𝗥𝗶𝘀𝗸 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 for E&L are the foundation for mitigating product risks. ✔️𝗜𝗻𝘁𝗲𝗿𝗮𝗰𝘁𝗶𝘃𝗲 𝗘𝘅𝗲𝗿𝗰𝗶𝘀𝗲𝘀: Participants engaged in hands-on activities and real-world case studies to apply their knowledge effectively. To speak with our E&L experts contact information@bpt.eurofinseu.com Learn more from our website - https://lnkd.in/ecpmN3P8 #eurofins #testingforlife #usp665 #extractables #leachables

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  • 𝗪𝗼𝗿𝗸𝘀𝗵𝗼𝗽 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 ❗ Our workshop on E&L and CCIT took place this week. A big thank you to all our attending guests and our speakers from Eurofins BioPharma Product Testing Italy for making this an exciting experience. 𝗪𝗼𝗿𝗸𝘀𝗵𝗼𝗽 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗮𝗻𝗱 𝗟𝗲𝗮𝗿𝗻𝗶𝗻𝗴𝘀: ✔️𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀: Adapting to regulatory changes, especially USP <665>; is a major challenge for the pharmaceutical industry.  ✔️𝗥𝗶𝘀𝗸 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 for E&L are the foundation for mitigating product risks.  ✔️𝗜𝗻𝘁𝗲𝗿𝗮𝗰𝘁𝗶𝘃𝗲 𝗘𝘅𝗲𝗿𝗰𝗶𝘀𝗲𝘀: Participants engaged in hands-on activities and real-world case studies to apply their knowledge effectively. Stay tuned for our upcoming events! Missed the workshop? Don’t worry – contact our experts to request the full presentation, and customised assistance. 📧 BioPharma.Switzerland@bpt.eurofinseu.com  🌐 https://lnkd.in/ec-cYE-r #Workshop #CCIT #Pharma #RegulatoryRequirements #USP665 #RiskAssessment #EurofinsBPT #Extractables #Leachables

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  • 𝗗𝗼𝗻'𝘁 𝗺𝗶𝘀𝘀 𝗼𝘂𝘁 𝗼𝗻 𝘁𝗵𝗶𝘀 𝗼𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝘆 𝘁𝗼 𝗲𝗹𝗲𝘃𝗮𝘁𝗲 𝘆𝗼𝘂𝗿 𝗘&𝗟 𝗮𝗻𝗱 𝗖𝗖𝗜𝗧 𝗸𝗻𝗼𝘄𝗹𝗲𝗱𝗴𝗲 ❗   In just two days, our 𝗵𝗶𝗴𝗵𝗹𝘆 𝗮𝗻𝘁𝗶𝗰𝗶𝗽𝗮𝘁𝗲𝗱 𝘄𝗼𝗿𝗸𝘀𝗵𝗼𝗽 will take place. We are excited to welcome industry experts to connect and dive into the latest insights on “Extractables and Leachables and Container Closure Integrity Testing.”    We look forward to hearing from our expert speakers, engaging in dynamic discussions, and giving you an exclusive tour of our microbiology laboratory.    𝟯 𝗦𝗽𝗼𝘁𝘀 𝗟𝗲𝗳𝘁! 𝗟𝗮𝘀𝘁 𝗖𝗵𝗮𝗻𝗰𝗲 𝘁𝗼 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 ❗ https://lnkd.in/gkPwuUqW    📅 Date: 26 March 2025  🕒 Time: 08:30 – 17:30   📍 Location: Schönenwerd, Switzerland    Do you have any final questions before the workshop? Contact our team!  📧 BioPharma.Switzerland@bpt.eurofinseu.com    #Workshop #Extractables #Leachables #CCIT #Innovation #GMP #BioPharma 

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  • 𝗨𝗻𝗱𝗲𝗿𝘀𝘁𝗮𝗻𝗱𝗶𝗻𝗴 𝘁𝗵𝗲 𝗜𝗺𝗽𝗮𝗰𝘁 𝗼𝗳 𝗖𝗖𝗜𝗧 𝗼𝗻 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗣𝗮𝗰𝗸𝗮𝗴𝗶𝗻𝗴 ❗ 𝗖𝗼𝗻𝘁𝗮𝗶𝗻𝗲𝗿 𝗖𝗹𝗼𝘀𝘂𝗿𝗲 𝗜𝗻𝘁𝗲𝗴𝗿𝗶𝘁𝘆 𝗧𝗲𝘀𝘁𝗶𝗻𝗴 (𝗖𝗖𝗜𝗧) is a critical aspect of pharmaceutical packaging development, ensuring that closure systems 𝗽𝗿𝗼𝘁𝗲𝗰𝘁 𝗮𝗴𝗮𝗶𝗻𝘀𝘁 𝗰𝗼𝗻𝘁𝗮𝗺𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗲𝗻𝘃𝗶𝗿𝗼𝗻𝗺𝗲𝗻𝘁𝗮𝗹 𝗶𝗺𝗽𝗮𝗰𝘁. Given the stringent requirements for container closure systems, CCIT plays a vital role in maintaining product integrity and compliance. 𝗛𝗼𝘄 𝗖𝗖𝗜𝗧 I𝗺𝗽𝗮𝗰𝘁𝘀 𝗣𝗮𝗰𝗸𝗮𝗴𝗶𝗻𝗴 ✅ 𝗗𝗲𝗳𝗶𝗻𝗶𝗻𝗴 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 & 𝗠𝗮𝘁𝗲𝗿𝗶𝗮𝗹 𝗦𝗲𝗹𝗲𝗰𝘁𝗶𝗼𝗻 CCIT helps establish the 𝗠𝗮𝘅𝗶𝗺𝘂𝗺 𝗔𝗹𝗹𝗼𝘄𝗮𝗯𝗹𝗲 𝗟𝗲𝗮𝗸𝗮𝗴𝗲 𝗟𝗶𝗺𝗶𝘁 (𝗠𝗔𝗟𝗟), a critical threshold based on sterility, stability, and safety considerations. By applying a wide range of different methods CCIT ensures that materials and closures provide the necessary 𝗯𝗮𝗿𝗿𝗶𝗲𝗿 𝗽𝗿𝗼𝗽𝗲𝗿𝘁𝗶𝗲𝘀 to prevent ingress of gases, moisture, or microbes. ✅ 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗢𝗽𝘁𝗶𝗺𝗶𝘀𝗮𝘁𝗶𝗼𝗻 & 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 CCIT supports the validation of sealing parameters, capping forces, and closure integrity, ensuring repeatable and controlled packaging processes. Techniques such as Vacuum Decay and Laser-Based Headspace Analysis help confirm that packaging meets performance requirements in 𝗮𝗰𝗰𝗼𝗿𝗱𝗮𝗻𝗰𝗲 𝘄𝗶𝘁𝗵 𝗜𝗖𝗛 𝗤𝟱𝗖 𝗮𝗻𝗱 𝗨𝗦𝗣 <𝟭𝟮𝟬𝟳> guidelines. Additionally, CCIT plays a key role in risk assessment, 𝗶𝗱𝗲𝗻𝘁𝗶𝗳𝘆𝗶𝗻𝗴 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗰𝗼𝗻𝘁𝗿𝗼𝗹 𝗽𝗼𝗶𝗻𝘁𝘀 where integrity failures could occur, particularly in aseptic or sterile product manufacturing. ✅ 𝗦𝘁𝗮𝗯𝗶𝗹𝗶𝘁𝘆 & 𝗧𝗿𝗮𝗻𝘀𝗽𝗼𝗿𝘁𝗮𝘁𝗶𝗼𝗻 Beyond initial validation, CCIT ensures that packaging maintains integrity under 𝗿𝗲𝗮𝗹-𝘄𝗼𝗿𝗹𝗱 𝘀𝘁𝗿𝗲𝘀𝘀 𝗰𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻𝘀. Factors such as pressure fluctuations due to altitude changes, vibration during transit, and thermal variations can compromise closure integrity. 𝗗𝗼𝗻'𝘁 𝗺𝗶𝘀𝘀 our E&L and CCIT workshop on 26 March 2025—an opportunity to expand your CCIT expertise in • Life Cycle Risk Assessment • Probabilistic vs Deterministic Methods • Case Studies • Method Setup and Validation ...and much more. 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗻𝗼𝘄—𝘀𝗽𝗼𝘁𝘀 𝗮𝗿𝗲 𝗹𝗶𝗺𝗶𝘁𝗲𝗱 ❗ https://lnkd.in/gkPwuUqW 📅 26 March 2025 - 08:30-17:30 📍 Schönenwerd, Switzerland 𝗖𝗼𝗻𝘁𝗮𝗰𝘁 𝘂𝘀 𝗳𝗼𝗿 𝗺𝗼𝗿𝗲 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻: 📧 BioPharma.Switzerland@bpt.eurofinseu.com 🌐 https://lnkd.in/dAbam6TR #CCIT #PackagingDevelopment #PharmaceuticalPackaging #QualityAssurance #RiskAssessment 

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