Featured Articles
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Parenteral Packaging And Delivery Systems: Container Closure Integrity
Review the chapter, USP <1207> Package Integrity Evaluation – Sterile Products, which covers CCI and different methods of selection and validation.
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The Importance Of An Analytical Testing Strategy
A proper and well-thought-out combination product testing strategy, rooted in applicable guidances in sync with scientifically sound methods, data capture, and reporting and retainment, is critical.
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How To Address Challenges In Oncology Drug Containment
Drug product containment systems comprising Daikyo Crystal Zenith® cyclic olefin polymer (COP) vials, matched with NovaPure® stoppers, offer container closure integrity (CCI) performance that has been quantified for oxygen and carbon dioxide, and they have excellent system performance.
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Selecting Container Closure Components: A Data-Driven Approach To CCI
Discover an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.
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Streamlining Primary Container And Device Selection With Predictive Calculations
Expolore a theoretical approach to complement experimental approaches to more quickly select a packaging and delivery system for your drug product.
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Key Considerations For Selecting Fill/Finish Manufacturing Technologies
Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.
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Moving From Vial Systems To Prefilled Syringes And Autoinjector Systems
Moving from vial systems to prefilled syringes and autoinjector systems requires patient and caregiver needs, drug product requirements, system components, and performance.
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Early Decisions To De-Risk The Transition To Combination Products
The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?
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Addressing Glass Particulates In Injectable Drug Formulations
Learn how a new vial design that is capable of reducing the propensity for glass particulate generation on filling lines is enabling a significant, positive impact on product quality and safety.
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Responding To Trends In Prefilled Delivery: Component Assessment And Selection
Existing plunger technology for PFS was developed for manual injection and does not meet the evolving requirements for drug delivery especially for consistency of injection rate.