Innovative Approaches to Vial Closure Systems

The Thermo Scientific ™ Chromacol 9 mm screw thread closure (K-Series) is our most recent product innovation and is designed to enhance your work flow by improving how samples are handled. Featuring Advanced Vial Closure System (AVCS) technology, the K-Series closure will instantly enhance your laboratory’s performance. From improved

The Thermo Scientific ™ Chromacol 9 mm screw thread closure (K-Series) is our most recent product innovation and is designed to enhance your work flow by improving how samples are handled. Featuring Advanced Vial Closure System (AVCS) technology, the K-Series closure will instantly enhance your laboratory’s performance. From improved

The Thermo Scientific ™ Chromacol 9 mm screw thread closure (K-Series) is our most recent product innovation and is designed to enhance your work flow by improving how samples are handled. Featuring Advanced Vial Closure System (AVCS) technology, the K-Series closure will instantly enhance your laboratory’s performance. From improved

Jun 7, 2021 · This paper presents a new integrated approach, that is an innovative and powerful tool for CCI evaluations. It accounts for both diffusion and mass/volumetric flow in real-time seamlessly, and can solve problems arising from real world applications. This modeling approach is based on the law of conservation and continuity for molecular flow

The system suitability controls for container closure integrity testing of syringes and pens are prepared with a relatively large defect size (removing the needle shield).

Mar 11, 2021 · Intravitreal (IVT) administration of therapeutics is the standard of care for treatment of back-of-eye disorders. Although a common procedure performed by retinal specialists, IVT administration is associated with unique challenges related to drug product, device and the procedure, which may result in adverse events. Container closure configuration plays a crucial role in maintaining product

Oct 11, 2022 · For vial-based products, the use of a reusable injection pen, along with a vial-to-cartridge reconstitution system, can simplify the delivery without the need to change the fill-finish process. In this solution, a system like Duoject Medical Systems ’ PENPREP EVO™* allows the reconstitution of solid-form drugs in vials with standard diluent

Advanced Vial Closure System (AVCS) Technology Innovative Closure Technology. Unmatched performance The new AVCS closures are designed to help chromatographers achieve more reliable and efficient sample analysis. Designed to accommodate nearly all chromatography autosamplers fitted for 12x32mm vial trays, these

Nov 16, 2022 · The Agency encourages firms to adopt more innovative approaches to ensuring adequacy of mixing (see, e.g., the guidance for industry PAT—A Framework for Innovative Pharmaceutical Development

The assurance of sterility of a parenteral drug product, prior to any human use, is a regulatory requirement. Hence, all strategies related to container closure integrity (CCI) must demonstrate absence of microbial contamination through leaks as part of the container closure system (CCS) qualification, during manufacturing, for quality control purposes and to ensure microbiological integrity

• FDA Guidance: Container Closure Systems for Packaging Human Drugs and Biologics (May 1999) • DRAFT Guidance for Industry: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (2009) • Variety of ISO standards are also useful

Learn how the DeltaCube™ Modeling Platform helps to facilitate data-driven selection & optimization of vial container closure system (CCS) components in Pharmaceutical Drug Packaging .

Typical Primary Parenteral Vial System. 17 R. Qualifying Integral Container Closure Systems. Presented at the PDA Annual Meeting, San Antonio, TX, 2014. 27

When the U.S. FDA published Guidance for Industry: COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance in March 2021, it opened the door for regulatory relief for certain post-approval changes (1). This article makes four recommendations for prior-approval supplement (PAS) relief to CBE-30 and offers two

32060224. DOI: 10.5731/pdajpst.2019.010843. 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.