#Container Closure Integrity (CCI)

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Incorporating advanced technologies like the VeriPac series and Seal-Sensor PQX, package integrity testing revolutionizes nutraceutical quality control, ensuring products meet rigorous standards for safety and efficacy. By swiftly detecting defects and maintaining packaging integrity, these systems play a vital role in safeguarding the quality and reliability of nutraceuticals in an evolving market landscape.

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The container closure integrity testing services market is projected to grow at a CAGR of 7% till 2035

Patient safety is one of the critical aspects of pharmaceutical industry, which makes it imperative for drug manufacturers and packaging service providers to evaluate the integrity of drug formulations packed in various container closure systems

 Roots Analysis has announced the addition of “Container Closure Integrity Testing Services Market, 2022-2035” report to its list of offerings.

 The report features an extensive study on the extensive study of the current landscape and the likely future potential of container closure integrity testing services, over the next decade. The study also features an in-depth analysis, highlighting the capabilities of various industry stakeholders engaged in this field. In addition to other elements, the study includes:

§  A detailed assessment of the overall market landscape of container closure integrity testing service providers based on a number of relevant parameters. In addition, it presents details of the companies, highlighting their year of establishment, company size, and geographical presence.

§  A detailed competitiveness analysis of container closure integrity testing service providers, taking into consideration several relevant parameters.

§  Tabulated profiles of the key players providing container closure integrity testing services, which are headquartered in North America and Europe. Each profile includes an overview of the company, information on the financial performance (if available), product portfolio, recent developments, and an informed future outlook.

§  A case study providing the list of equipment used by various manufacturers to test container closure integrity, highlighting their key features, type(s) of analytical method(s) offered, type(s) of container(s) tested, container material(s) of container closure integrity testing technologies.

§  A detailed competitiveness analysis of container closure integrity testing equipment, taking into consideration several relevant parameters.

§  A regional capability assessment framework, which compares the container closure integrity testing capability across key geographies, based on a number of parameters.

§  A detailed analysis of the various container closure integrity testing analytical techniques. It highlights the popularity of analytical techniques and offers a benchmark to compare analytical techniques.

§  A case study on the use of robotic machinery in pharmaceutical manufacturing and fill / finish operations, highlighting the advantages of using automation / automated technologies in such processes. Further, it presents the profiles of industry players that provide such equipment for aseptic processing of pharmaceuticals.

§  An in-depth analysis to estimate the current and future demand of container closure integrity testing service based on various relevant parameters.

§  A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall industry.

 §  By 2035, the financial opportunity within the container closure integrity testing services market has been analyzed across the following segments:

 §  Analysis by Type of Container Closure System

Vials

Syringes

Cartridges

 §  Analysis by Type of Container Material

Glass

Plastic

 §  Analysis by Geographical Regions

North America

Europe

Press Release: Variation 1 (Format 2)

  Europe

Asia Pacific

MENA

Latin America

Rest of the World

  Europe

Asia Pacific

MENA

Latin America

Rest of the World

  Key companies covered in the report:

§  Berkshire Sterile Manufacturing

§  Confarma

§  Curia

§  DDL

§  Eurofins

§  Nelson Labs

§  SGS

§  Stevanato Group

§  Wilco

  For more information, please click on the following link: 

https://www.rootsanalysis.com/reports/container-closure-integrity-testing-services-market.html

 Other recent offerings:

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5.     Pre-Sterilized / Ready-to-Use Primary Packaging Market: Industry Trends and Global Forecast, 2021-2030

 About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If you’d like help with your growing business needs, get in touch at info@rootsanalysis.com

 Contact Information

Roots Analysis Private Limited

Ben Johnson

+1 (415) 800 3415

ben.johnson@rootsanalysis.com

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Container Closure Integrity Testing Methods | Seal Tick

Container closure integrity (CCI) testing is a critical component of quality assurance for sterile products. As such, pharmaceutical packaging companies need to be sure that the closures on their products are free of leaks that could potentially contaminate drug product.

There are several CCI testing methods available to detect leaks in packaging. Some of the most common include microbial ingress, dye ingress and high voltage leak detection. While each method has its advantages, selecting the right test method depends on the unique characteristics of the packaged product and primary package.

Microbial Ingress Testing:

Microbial ingress testing is a traditional CCI test for sterile containers and devices that is typically carried out by immersing the sample in a bacterial suspension under alternating vacuum and overpressure. This is often accompanied by additional testings such as growth promotion and validation studies.

While this is an effective and affordable CCI test method, it has some limitations. Besides its limited detection capacity, it may also introduce false positives as a result of microbial contaminants that may be introduced into the sample during the test. It is also a destructive test, which means that the samples must be destroyed after the testing.

Deterministic CCIT Tests:

Deterministic tests are non-destructive and can be repeated over time. They are also less likely to be subjected to human error, thereby improving accuracy.

They are also usually able to provide more granular data than probabilistic methods. This is important for manufacturing because it allows companies to design an appropriate test program based on knowledge of the package and its seals.

For example, if the manufacturer has experience of using the same packaging material and sealing systems in previous trials, they will know what the maximum allowable leakage limit is for their particular application. This information can then be used to determine how much CCI testing should be performed.

Choosing the right CCI test methodology is crucial to the success of your manufacturing process. It will ensure that your products are safe for use and can meet their intended purpose.

It is important to understand that different products require different leak rates for optimal shelf-life and performance. This is why it is important to choose a CCI testing method that can accurately identify leak sizes that correspond to the leak rate appropriate for your product.

The USP 1207> chapter 'Package Integrity Evaluation - Sterile Products', implemented in late 2016, is an excellent source of guidance on deterministic CCI testing methods. It provides recommendations on the selection and validation of CCI testing methods, sample size, use of positive / negative controls and acceptance criteria for each method.

There are a number of other factors that must be taken into consideration when selecting the right method for your specific application, including the package and the product. This is why it is crucial to consult an experienced manufacturer such as Ascend Packaging Systems who will be able to assist you in finding the best CCI test method for your product.

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A Paradigm Shift In Container Closure Integrity Of Parenteral Drugs

A Paradigm Shift In Container Closure Integrity Of Parenteral Drugs

Industrial Management Consulting

http://www.manostaxx.com

Container Closure Integrity (CCI) is defined by whether a container maintains the sterile barrier. If there is a leak or breach of the sterile barrier, environmental contaminants can rapidly convert a life saving treatment into a microbial soup. Parenteral products are the highest risk of all package formats. Vials, ampoules and prefilled…

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The rise of flexible packaging has revolutionized various industries, offering lightweight, efficient, and versatile solutions. The global demand for flexible packaging is projected to continue its upward trajectory, driven by several factors. These include cost-effectiveness, sustainability, and versatility. Compared to rigid alternatives, flexible packaging offers significant cost advantages in terms of materials, transportation, and storage. Advancements in material science are leading to the development of eco-friendly flexible packaging solutions, catering to the growing demand for sustainable practices. Additionally, flexible packaging offers exceptional design flexibility, allowing for unique shapes, sizes, and printing options to enhance product branding and consumer appeal.

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Solutions, suspensions, emulsions for injection or infusion, powders for injection or infusion, gels for injection, and implants are all considered parenteral preparations. They are sterile products designed to be injected directly into patients. Parenteral drug products must be free from pyrogenic substances, bacteria, and other visible particles. Parenteral drug products that are contaminated can seriously harm the patient’s health. Therefore, in the manufacturing of parenteral drugs, sterility assurance and pharmaceutical package testing are crucial.

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For pouches and other flexible packaging, VeriPac FLEX systems are versatile non-destructive package inspection systems. These are available in a variety of configurations for the leak test instrument and the test chamber capacity, with solutions to accommodate small format sachets and stick packs up to bulk size pouches and bags. This is done to accommodate different package specifications and test sensitivity requirements. The Food and Drug Administration (FDA) has recognized the ASTM technique for Vacuum Decay leak testing (F2338) defined in ISO 11607 as a consensus standard for pharmaceutical package testing. This approach is used by VeriPac FLEX Systems.

VeriPac inspection systems are the best alternative for destructive testing since they eliminate the subjectivity of test results and reduce the waste and costs associated with these techniques. Comparing Vacuum Decay leak testing technology to destructive techniques like the water bath or blue dye leak test, it has been found to offer a quick return on investment. The VeriPac test provides reliable critical packaging failure detection and useful packaging process insight.

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When determining the integrity of pharmaceutical and medical devices, Vacuum decay leak testing is the best non-destructive option. The test measurement generates a reliable and accurate quantitative result, as well as a pass or fail decision. The FDA recognizes the standard Vacuum Decay leak test technique (ASTM F2338) as a consensus standard for evaluating container closure integrity (CCI). The test technique is referenced in the United States Pharmacopeia Chapter on CCI (USP Chapter 1207) and listed in ISO 11607.

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Pharmaceutical containers like vials protect the product from contamination (sterile barrier) and prevent changes in product quality caused by external factors. In order to determine the functionality of such systems, container closure integrity testing is performed. CCIT provides sophisticated analytical methods for evaluating pharmaceutical containers. MicroCurrent HVLD is one such method.

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Automated Container Closure Integrity (CCI) solutions represent a pivotal advancement in pharmaceutical manufacturing, offering numerous benefits that enhance product quality, safety, and regulatory compliance. By replacing manual testing methods with automated systems, pharmaceutical companies can streamline the CCI testing process, improve accuracy, and increase efficiency. These solutions utilize advanced technologies such as vacuum decay, MicroCurrent HVLD, and high-speed imaging to detect even the smallest leaks or defects in packaging systems. As a result, they minimize the risk of product contamination, ensure product sterility, and uphold regulatory standards.

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CCI testing methods for vials, ampoules, and syringes are essential for ensuring the quality, safety, and efficacy of pharmaceutical products. By employing proper container closure integrity testing, manufacturers can identify and mitigate potential risks associated with container closure integrity, thereby safeguarding patient health and regulatory compliance. Continuous advancements in testing technologies and regulatory standards further contri

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The development of robust test methods for assessing Container Closure Integrity (CCI) is essential for ensuring the safety, efficacy, and quality of packaged products across various industries. By employing appropriate methodologies and considering key factors in method development, manufacturers can uphold product integrity, comply with regulatory requirements, and safeguard consumer health and trust. Continuous innovation and refinement in CCI testing methodologies will contribute to advancements in packaging technology and product quality assurance in the future.

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Recent regulatory changes have shifted requirements and strategies for container closure integrity. IV bags and flexible parenteral presentations have experienced the greatest impact from these new perspectives on quality. IV bags have always presented a significant risk. New provisions to Annex 1 have made the requirements for quality risk management (QRM) clear, and USP guidance documents outline the need for greater control. Based on the regulatory requirements and guidance, practical solutions for IV bag container closure integrity should offer non-destructive, practical and deterministic approaches to assure integrity. There are critical considerations for IV bag QRM, and strategic approaches to assuring integrity of IV bags and flexible parenteral presentations to satisfy the shifting regulatory environment.

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Parenteral products are typically tested for their container closure integrity (CCI) to ensure that the product remains sterile and safe for use. Automated CCI solutions can provide a fast and reliable method for testing CCI in parenteral products. These solutions offer several benefits over traditional manual testing methods, including increased efficiency, consistency, and accuracy. Automated CCI solutions typically use non-destructive testing methods, such as vacuum decay or high voltage leak detection, to identify any leaks or defects in the container closure system. These methods are highly sensitive and can detect even the smallest leaks that may compromise the sterility of the product.