INSIGHTS ON PHARMACEUTICAL PACKAGING
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Meeting Annex 1: A Proactive Approach To Regulatory Compliance
It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision.
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Determining The Limit Of Detection In CCIT
Accurately determining the smallest detectable defect in pharmaceutical packaging is essential for sterility. Learn how test sensitivity, positive controls, and regulatory standards shape CCI strategies.
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Ensuring Integrity: A Comprehensive Approach To CCI
Deterministic CCI testing ensures compliance in packaging. Learn how advanced methods like Vacuum Decay, HVLD, and Helium Leak Detection deliver results aligned with USP 1207 and global standards.
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Vial Containment Systems Based On Elastomer 4031/45 Gray
Examine the results of two, two-year studies that indicate good container closure integrity performance that can be achieved with stoppers of a given elastomer, independent of configuration.
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Integration Of Container Closure Integrity In Contract Manufacturing3/28/2025
Maintaining drug product sterility and compliance demands rigorous Container Closure Integrity (CCI) within contract manufacturing. Learn how to fortify your processes.
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Establishing And Safeguarding Shelf Life In Combination Products10/27/2025
Establishing combination product shelf life requires aligning stability. Holistic, data-driven stability studies ensure product function, safety, and label claims through the entire supply chain.
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Blister Solutions3/4/2025
With over 6,000 tooling parts and an in-house machining center to ensure precision, explore this versatile blister service that provides both Thermoformed and Cold-Formed solutions.
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The Enhanced Version Of Ready-To-Use Vial Platform1/13/2025
Discover a platform for aseptic manufacturing that offers pre-sterilized vials for biologics to improve efficiency and safety with automated filling systems and advanced packaging for optimized drug containment.
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Supporting GLP-1 And Peptides With Integrated Solutions9/30/2025
Accelerate GLP-1 and peptide therapy development with integrated drug containment, delivery, machinery, and analytics for reliable combination product performance.
PHARMACEUTICAL PACKAGING SOLUTIONS
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Explore an approach that accelerates your project through key milestones with a technology transfer process that ensures a fast start and process analytical technology that increases efficiency and reduces cost.
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Clinical trials are an important milestone for the approval of innovative medical products. Our customized packaging solutions contribute to the success of such trials.
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PCI offers over 30 years’ experience in the storage and distribution of clinical trial materials, effectively storing and distributing thousands of patient kits to over 100 countries world-wide.
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Weiler Engineering’s ASEP-TECH® Blow/Fill/Seal machines are ideal for processing temperature sensitive products such as biological and protein-based materials – providing a level of enhanced sterility assurance.
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The United States Pharmacopeia USP 1207 guidance has been revised, encouraging the preference to deterministic, quantitative, and reliable non-destructive technologies to comply with quality standards.