Advancements in Vial Closure Systems for Enhanced Leak Detection and Sample Security
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Advances in Container Closure Integrity Testing - ResearchGate
Sep 3, 2013 · Standard 10-mL vials were modified to contain pinholes (0.5 to 10 microns) by affixing micropipettes with epoxy into 2-mm vial side wall holes. The absolute leak rate was determined using vials
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CHAPTER 3 Underground Storage Tanks - Defense Logistics Agency
3.3.4 UST Leak Detection all USts systems must have a method of leak detection. Use one, or a combina-tion, of the following monitoring methods at least every 30 days: Vapor monitoring in soil Interstitial monitoring (detection of liquids in the space between a tank and its outer containment wall) automatic tank gauging
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Pressure Decay: The Container Closure Integrity Testing for
3mm from the bottom of the vial), using a worst-case approach: challenging the potential clogging of the leaks generated. In addition, large leaks detection at closure level was evaluated. The parameters validated were: system suitability; accuracy; precision; limit of detection (LOD); specificity, and range (4).
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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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Container Closure Integrity Testing - Practical Aspects and
Oct 27, 2016 · No vial showed any leakage greater than 10(-8)mbar L/s as measured by a helium mass spectrometry system, suggesting that container closure integrity was warranted in the residual seal force range
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Container Closure Integrity Testing - Semantic Scholar
addition, the measurement of leak detection is based on physicochemical technologies that are readily controlled and monitored, yielding objective quantitative data. High voltage leak detection (electrical conductivity and capacitance Laser-based headspace analysis Helium leak test Mass extraction, mass flow Pressure decay
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Understanding the mechanisms of liquid leakage & microbial
The implementation of additional tests, such as point-of-use leak testing, may be required depending on the criticality of the application. Figure 1 describes the life-cycle complexity of a Single-Use System and the validation, qualification, and control steps to ensure integrity. 4. Identification of the Maximum Allowable Leakage Limits
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Safeguarding Vial Container Closure Integrity: A Systematic
To ensure patient safety and meet regulatory requirements for container closure system, a number of factors must be addressed, including risks associated with gas and moisture ingress, changes in vacuum pressure, leakage, capping, sealing, visual inspection acceptance, and temperature cycling.
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(PDF) Liquid Immersion Microbial Challenge Tests: Microbial
Dec 10, 2017 · Tests to verify the container-closure can be grouped as microbial tests or non-microbial (physical) tests. Physical tests include the dye test; vacuum testing (typically leak testing with
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Container Closure Integrity Testing | Pharmaceutical Packaging
Jul 31, 2023 · Best Application: This technology accommodates both seal and package integrity testing for flexible packaging, such as bags and pouches. This is a destructive test. High Voltage Leak Detection. Instrumentation: E-Scan 655 MicroCurrent High Voltage Leak Detector (HVLD) Description: Detects package defects using an electrical current.
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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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Advances in Container Closure Integrity Testing | SpringerLink
Jan 1, 2013 · 1 Introduction A primary container closure system provides the critical barrier that protects drug product contained therein. For sterile products, container closure integrity (CCI) is an inherent and critical component of the overall sterility assurance program.
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Container Closure Integrity Testing Frequently Asked Questions
A key part of this phase is the development of instrument change parts specific the container-closure system to be tested and the creation of positive control samples (laser drilled and size certified) on actual empty containers. Typically phase one is 6- 10 weeks. The next phase brings the project to method development.
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VERIFYING THE CONTAINER CLOSURE INTEGRITY OF CUSTOM PRIMARY
Oct 26, 2020 · Gilcrist J et al, “Helium Leak Test for Micron-Sized Holes in Canned Foods”. J Food Prot, 1985, Vol 48 (10), pp 856–860. Kirsch LE, Nguyen L, Moeckly CS, “Pharmaceutical container/closure integrity. I: Mass spectrometry-based helium leak rate detection for rubber-stoppered glass vials”. PDA J Pharm Sci Technol, 1997, Vol 51(5), pp 187
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Container Closure Integrity Testing (CCIT): safety in numbers
Off-line systems tend to be dedicated to a specific testing method, although multi-functional machines capable of performing several different tests through the addition of attachments are now available. Off-line leak testers cost a fraction of the price of in-line systems to validate and are capable of detecting smaller leaks than in-line systems.
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