Mar 9, 2023 · Study 4 assessed the CCI of the vial-stopper combination after three months of extended storage at -80°C. The vial-stopper-seal combination was comprised of the following components: West NovaPure ® 4432/50G 13mm and 20mm stoppers. West Flip-Off ® 13mm and 20mm seals with TruEdge ® technology. Corning ® Valor ® Glass vials 2R and 10R

AVCS technology, SureStop vials offer the sealing and performance characteristics of a crimp top vial and the versatility and convenience of a threaded vial. This is achieved by incorporating a definite stop point into the design of the vial finish, preventing over tightening of the closure. SureStop vials remove all doubt about the degree

• Loosely capped vial more likely to leak during product life-cycle •High RSF • Overly compressed vial more likely to leak due to vial scoring or closure/seal distortion •Low or High RSF • Indicative of possible sealing process failure • Indicative of possible component changes Seal Quality Tests 18

Feb 27, 2020 · Introduction. Pharmaceutical product container closure systems (CCS) should be designed to ensure that a drug product (1) is protected from factors that may impact product quality over its shelf life, including light, evaporation, exposure to gases, absorption of water, or microbial contamination; (2) is compatible with the selected CCS and that there is a lack of product—CCS interactions

designed as part of the Advanced Vial Closure System (AVCS), and remove subjectivity around achieving the optimal seal compression when closing a vial. As an integral component of AVCS technology, SureStop vials offer the sealing and performance characteristics of a crimp top vial and the versatility and convenience of a threaded vial.

DWK Life Sciences I-Loc closures combine the advantages of an aluminum seal with the convenience of a screw cap. The innovative design consists of an open-top polypropylene (PP) screw cap, which is connected to a gray bromobutyl stopper. I-Loc closures are available in five different colors and can be autoclaved.

inconsistent vials sealing that threatens to destroy sample integrity, to increased flexibility and handling with vial/ septa combinations, the 9 mm closure will drive your laboratory to even greater performance levels. At the core of the new National series of closures is the Advanced Vial Closure System technology. Simply stated, AVCS allows

AVCS technology, SureStop vials offer the sealing and performance characteristics of a crimp top vial and the versatility and convenience of a threaded vial. This is achieved by incorporating a definite stop point into the design of the vial finish, preventing over tightening of the closure. SureStop vials remove all doubt about the degree

Previous works had explored the use of Oxygen Headspace Analysis to measure CCI at low temperatures. Here, we present the evaluation of CCI of rubber-stoppered aluminosilicate glass vials (Valor®) and plastic vials (Crystal Zenith®) using Helium leak CCIT method at -80oC, with correlation to Residual Seal Force (RSF).

Jul 19, 2022 · Effect of Blowback on CCI of Crimped Vials. Lyophilization V-50-I (13mm) and S-87-I (20mm) stoppers, formulation 4040/40 paired with ISO standard glass vials with no blowback, EU blowback and US were then crimped with aluminum seals and CCI was measured via helium leak test method (Technical Report 2019/211). All tested combinations passed CCI.

The optional module for 100 % CCIT using the proven high voltage leak detection (HVLD) technology ensures the reliable detection of container closure defects. Benefits: Innovative camera technology for accurate inspection results; Product-specific spinning profiles due to individual direct drives (48 servo motors)

Mar 24, 2022 · Dimensional compatibility of the vial, stopper, and seal ; Empty or filled vials (e.g., liquid presence and the type of liquid, partial pressure, gas overlay) Machinability. Machinability is a term used to describe the effectiveness of a component (e.g., container, stopper, plunger, or seal) processed on drug product filling line.

environment for the “we’ve always done it that way” approach to the technology. The corporate focus of Weiler Engineering, Inc. is to provide the most advanced aseptic liquid processing technology available through the application of customized ASEP-TECH® Blow/Fill/Seal machinery and integrated services.

closures is the Advanced Vial Closure System technology. Simply stated, AVCS allows your closure to perform like never before. The C5000 series closures are fully compatible with all of the C4000 series Target DP 9 mm vials. Features: • Septa push through nearly eliminated due to improved interior geometry • Increased sealing capability

Apr 27, 2021 · The West analytical services team has an extensive portfolio of Container Closure Integrity (CCI) techniques and analysis for various packaging and delivery systems to meet the needs of pharmaceutical, biotech and medical device manufacturers. The road from concept to patient can sometimes be a "tortuous path," but the CCI analytical group has