Sample sizing approaches

How do you justify your sample sizes for container closure integrity testing? 

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 assessments and considering information such as supplier approval, packaging component specifications and process knowledge. 

Unfortunately, CCIT sampling approaches vary across the industry and there is no official standard or regulatory guidance for sampling or defining appropriate sample sizes. This is particularly important when using destructive test methods. 

A new BioPhorum paper addresses these gaps and more. Sample Sizing Approaches for Container Closure Integrity (CCI) Testing provides options for defining a justifiable sample size for CCIT and summarizes the options for risk-based strategies that will help readers consider their options for demonstrating a scientific justification for their approach. 

Targeted sampling and testing  

The paper could benefit readers in many ways. It illustrates how to avoid unnecessary sampling and testing without impacting product quality. For example, where the integrity of each container is assured by a suitably qualified process, additional CCI sampling and testing would not normally be required. Quality is built into the process itself and is not affected by sampling or testing. 

Also, increased sample sizes are often thought necessary for larger batch sizes, but the paper suggests that sampling based on the level of defects (and used in conjunction with common sampling plans) gives a more appropriate approach. 

“Testing each batch for CCI is not what we defend as we all trust our robust, holistic control strategies to guarantee the quality of our products,” said Henri Hebting, Manager MS&T at Eli Lilly. “Nevertheless, when you have to test, this paper gives good directions for appropriate sampling plans.” 

Published in American Pharmaceutical Review, the paper does not prescribe a one-size-fits-all approach that will fit all companies or products. Instead, it illustrates some concepts for scientifically justified sampling plans that will not place an unnecessary burden on industry (when applied within a robust quality management strategy). 

The strategies covered are not exhaustive but illustrate possible approaches that might be applied if a biopharmaceutical company needs to sample and test drug product lots for CCI. BioPhorum’s risk-based strategy will save them time, money and effort. 

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