Container closure


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Ask BioPhorum – a second brain for BioPhorum members

Whilst the filling and finish process is straightforward to describe, it is exquisitely complicated to get right and be assured and assure health authorities that the product reaches stringent quality standards. Even small deviations from standards can result in expensive losses and delay supply to patients of vital therapies.  Experience and expertize matter.  Ask BioPhorum is a valued member resource which enables subject...

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Sample sizing approaches

How do you justify your sample sizes for container closure integrity testing?  Most leading biopharmaceutical companies do not routinely perform container closure integrity testing (CCIT) for each batch of a commercial product, but rely on a holistic approach to ensure the consistent integrity of the finished product.  However, when sampling is required, scientifically valid approaches should be used, with plans based on risk...

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Aiming high with a User Requirements Specification for CCIT

Container closure integrity testing (CCIT) is critical for ensuring the safety and efficacy of parenteral drug product presentations. Unfortunately, current technology has many deficiencies in testing capability and cannot meet all user needs or test the increasing range of products most companies routinely support. To encourage the development of optimized technologies for CCIT, BioPhorum has written a User requirements specification (URS) for...

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Container Closure Integrity: User requirements specification (URS) for optimized container closure integrity testing equipment

The paper highlights a long-term desired view of CCIT to help develop equipment that can better meet end-user requirements. It will also provide confidence that CCIT methods can effectively demonstrate container integrity, such as microbial, headspace (gas, vacuum and moisture) and product integrity. It provides a long-term goal for companies that often use multiple CCIT technologies, with varied capabilities, to support the requirements of an expanding product portfolio. The URS will help overcome the significant inefficiencies that companies face. It will also help resolve the problem that the range of deterministic CCIT methods currently available do not represent a panacea for CCIT.

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

The release of the expanded USP<1207> in 2016 cast doubt over the validity of so-called probabilistic analytical methods, including one the biopharmaceutical industry’s most universal tests – the dye ingress method for container closure integrity

With the dye ingress method ubiquitously used without issue for decades, this paper highlights the continued value and applicability of this and other probabilistic analytical tests. In addition, this paper also describes how any method, whether probabilistic or deterministic, stands or falls on the quality of its development and validation, and not necessarily on the properties of the test itself.

The most important factor is to apply a test method is not how it is labelled, but lies in its development, qualification and whether it meets the need for which it is designed.

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Container closure integrity (CCI): Response to the publication of USP<1207>

USP published its revised and expanded guidance, USP<1207>, in 2016 ostensibly asking as many questions as it answered.

Specifically, USP<1207> implies ’probabilistic’ tests such as the ubiquitous dye ingress method are inferior and proposes a preference for so-called deterministic tests. The added assertions that deterministic methods can achieve high levels of sensitivity and accuracy do not reflect the ‘real world’ experience of the industry’s CCI experts whose work with the newer methods highlight a range of improvements that must be addressed before such claims can feature in guidance.

This paper makes the distinction that any method – probabilistic or deterministic – when properly validated may be regarded as acceptable, with no one method type worthy of a preferred status

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Container closure integrity (CCI): Container closure integrity control versus integrity testing during routine manufacturing

In 2014 uncertainty around regulation for container closure and integrity testing (CCIT) fed a perceptible shift in mindset across the industry, causing some concern amongst many subject matter experts in biological manufacturers. Their concern was that gaps in guidance was enabling skewed expectations such that they would promote 100% CCIT for the release of drug product batches. This paper addresses this concern by re-stating the principles of CCI, qualification, process control and in-process testing to establish the framework within all effective container closure integrity programs. It concludes that performing 100% CCIT does not provide certainty that a process is well controlled and introduces an additional step that is not always necessary or suitable for the high processing speeds in the industry.

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