Package Inspection Featured Articles
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Assembling The Package Integrity Profile For Autoinjectors
Due to their complexity, combination products present unique challenges in implementing a container closure integrity (CCI) testing strategy. Learn about these challenges and how to overcome them.
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Key Considerations For Selecting Flexible Fillers
Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.
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The Importance Of Container Closure Integrity (CCI) Feasibility Testing
In the CCIT space, one single inspection technology cannot be used for every type of pharmaceutical product. You should always weigh the various factors to determine the ideal inspection methodology.
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Single-Use Manufacturing Systems: Implementation Considerations
As single-use systems continue to evolve, more biopharma companies will be able to benefit from their ever-improving reliability and unique adaptability as part of both fully single-use and hybrid processes.
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Evaluating Container Closure Integrity Of High-Risk Pharmaceuticals
Manufacturing inconsistencies often result in container closure failure, causing serious implications down the supply chain. Learn why it is critical to use the most precise leak testing method possible.
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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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Mitigate Risk With Package Quality
Package testing and container closure integrity are cornerstones for quality. Now more than ever, innovative package designs are being used to differentiate and simplify pharmaceutical product delivery and end use. When defining package quality for your specific application there are two questions to answer.
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Incorporating Lean Principles Into Pharmaceutical QC Laboratory Design
This article presents a case study based on an international workshop hosted by Novartis Vaccines to prepare guidelines for incorporating lean principles into pharmaceutical quality control laboratory design. By Mike Dockery, Federico Gabardi, Javier Garay, Jim Gazvoda, Luke Kimmel, Pietro Orombelli, Christophe Peytremann, Tom Reynolds, Tanya Scharton-Kersten, Graham Shoel, and Jeanne Sirovatka
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Package Inspection Guidelines For Sterile Medical Products
Class III medical devices have a unique set of requirements and package characteristics. Numerous inspection methods exist for medical package inspection that require a thorough understanding to ensure quality.
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Establishing Turnkey Tech Transfer Processes For Drug Product
In addition to disrupting clinical trials and complicating day-to-day operations logistics, the pandemic has driven unprecedented demand for drug product, as sponsors and their CDMO partners strive to accomplish no less than vaccinating and curing the world’s population.