Advancements in Vial Closure Systems for Enhanced Sample Protection and Stability
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Container and Closure System Integrity Testing in Lieu of
May 6, 2020 · A container and closure system refers to the entirety of packaging components that together contain and protect the product. A packaging component means any single part of a container and closure
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A Vial Container Closure System Performance - PubMed
Epub 2020 Feb 14. Compatible vial container closure system (CCS) components in combination with a proper capping process are crucial to ensuring reliable performance, maintaining container closure integrity (CCI), and achieving CCS visual acceptance.
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The pharmaceutical vial capping process: Container closure
Feb 1, 2016 · In this review, the health authority requirements and expectations related to container closure system quality and container closure integrity are summarized. The pharmaceutical vial, the rubber stopper, and the crimp cap are described.
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Vials and well plates - Thermo Fisher Scientific
Headspace vials are the most popular vials for the analysis of gases and are suitable for headspace and SPME experiments. These products are suitable for GC systems. Sample storage Our 4, 8, 10, 16, 20 and 40 mL vials can be used for sample collection and sample storage. We have added a patch to these large vials, making it easy for you to
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Container Closure Integrity Testing Method Development and
Feb 20, 2013 · Utilization of prefilled syringes as a preferred container closure system for biologics has been increasing [1]. As a primary container closure system, prefilled syringes must provide an integral barrier that protects drug product stability and sterility throughout its entire shelf life. Drug manufacturers are required to check and demonstrate the system is capable of maintaining its microbial
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3.1 Packaging: assessment and common issues
of different components (e.g. bottle, vial, closure, cap, ampoule, blister) which surround the pharmaceutical product from the time of production until its use.' US FDA defines container closure system as 'the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components
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Container Closure Integrity Testing of Prefilled Syringes
Aug 1, 2018 · Abstract. Prefilled syringes (PFSs) are increasingly preferred over vials as container closure systems (CCSs) for injectable drug products when facilitated or self-administration is required. However, PFSs are more complex compared to CCSs consisting of vial, rubber stopper, and crimp cap.
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Container Closure Integrity Evaluation for Cell and Gene
Dec 23, 2020 · With the growth of gene and cell therapies, there is an increased need to characterize container closure systems (CCS) at the low temperatures experienced during their lifecycles: ultra-low (-80°C) for genes and cryogenic (-180°C) for cells. West’s Integrated Solutions platform includes the state-of-the-art container closure integrity (CCI
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Shifts in Container Closure Integrity Test Methods - ISPE
Sep 9, 2019 · Historically, probabilistic container closure integrity test methods such as water bath, dye, and microbial ingress tests have been used to determine package quality. These tests are limited in their effectiveness and reliability for several reasons. Chief among them are the subjectivity of the results, the lack of standardization, and the lack
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Container Closure Integrity Testing of Sterile Injectable
Determining a Strategy for Container Closure Integrity Testing of Sterile Injectable Products. Container closure integrity (CCI) plays an important role in maintaining the sterility and stability of sterile injectable products. The defects which cause a sterile vial to leak are not necessarily defects that will be detected by a visual
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Caps & Closures | DWK Life Sciences
If you are looking for a convenient closure system that does not require additional tools, screw caps can offer a good compromise of secure fit and ease of use. In contrast to crimp top and screw cap vials, snap cap vials are chosen strictly for convenience and for specific fill and finish equipment requiring nested snap cap configurations.
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Container Closure Integrity Testing of Primary Containers for
Jun 21, 2018 · Container closure integrity (CCI) is the ability of a container closure system—i.e., a package system—to provide containment and protection for the content inside. Ensuring the CCI of a parenteral product package is essential during the entire lifecycle of a product. The chapter first reviews the U.S. FDA regulatory requirements on CCI.
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A Vial Container Closure System Performance Optimization Case
Feb 14, 2020 · Abstract. Compatible vial container closure system (CCS) components in combination with a proper capping process are crucial to ensuring reliable performance, maintaining container closure integrity (CCI), and CCS visual acceptance.
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