EXTERNAL-RESOURCE

Container closure (CCI): Dye ingress methods for container-closure integrity testing: An industry position paper

15 September 2018
Fill Finish
Container closure (CCI): Dye ingress methods for container-closure integrity testing: An industry position paper

Dye Ingress Methods for Container-Closure Integrity Testing: An Industry Position Paper provides guidelines and best practices for the qualification and/or validation and use of a dye ingress test method within a company’s approach to container-closure integrity (CCI).

Written by the BIoPhorum Fill-Finish Container-Closure Integrity Testing (CCIT) Workstream, the paper summarizes the results of a  cross-industry survey of CCIT methods. This found that 11 of the industry’s top biopharmaceutical companies use dye ingress testing in 78% of CCIT situations. Despite not being the latest technology or particularly sophisticated, the survey shows that this method is vitally important to the industry. If your company depends on dye ingress to test and release your biopharmaceutical product, then this paper is a must-read.

The paper gives an overview of the dye ingress method and there is a detailed discussion on its advantages (and when to use it) and its limitations and gaps (and when not to use it). It also examines the critical factors and parameters that must first be considered and understood to adequately qualify a CCIT method. These include the limit of detection, the 20-µm ‘standard’, tracer liquid (dye) choice and surfactant use, and detection (UV and visual).

The Workstream suggests that any CCIT method, including dye ingress, should be qualified or validated for its intended use based on available scientific knowledge. This should be performed by qualified personnel using qualified equipment and consider the available guidance on validation, sensitivity and specificity.

The team considers that the most important factor of any test method is not whether a CCIT method is ‘preferred’ but whether it is well developed, qualified and fit for its intended purpose. It says that although the method is not always product- or container-compatible, where appropriate, dye ingress continues to provide container assurance.

NEWS
How our value-driven FIT approach can increase your process reliability and patient safety
Vials
NEWS
How to minimize the impact of CCIT on gene therapy batch yields
Coloured dots on teal, next to vial
NEWS
An industry first – a holistic approach to container closure integrity

Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

DOWNLOAD
An industry perspective on understanding AAV capsid content variants
Needle On Yellow Background
EXTERNAL-RESOURCE
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
DOWNLOAD
The Drug Substance 2.0 Strategic Value Framework
Coloured dots on teal, next to vial
DOWNLOAD
BioPhorum’s holistic approach to container closure integrity
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
NEWS
Inaugural BioPhorum Quality face to face – get involved
PODCAST
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
PODCAST
Delivering a Cell and Gene Therapy Outbound Supply Chain Pathway for the Industry
DNA and Earth on blue background
DOWNLOAD
A vision for the biopharmaceutical industry’s inbound supply chain
NEWS
A major milestone – a harmonized approach to product carbon footprint data
Technology Roadmap V 2.0
DOWNLOAD
BioPhorum Technology Roadmapping roadmap vision 2.0

Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing