Sterile Package test Deterministic vs. Probabilistic Testing
Sterilfe Package Test
This is a major reason that many pharma and medical device companies are intensifying their package testing and enhancing their test methods. Visual spot checks performed by humans are being augmented or replaced by non-destructive quantitative test solutions, ensuring that the container closure system performs as needed. New test methods have been developed that generate quantitative data that can provide objective pass/fail standards for every package.
Deterministic vs. Probabilistic Testing
The revised divides test methods into two subgroups: deterministic and probabilistic. The difference between deterministic and probabilistic methods is that deterministic methods are less subject to error, especially those errors associated with method execution and subjective interpretation of results.
Deterministic tests are performed with instruments that offer better repeatability and produce quantitative results, giving access to better statistical tools and a more robust solution. Examples of deterministic methods would include head space analysis, vacuum decay, and high-voltage leak detection. A number of the methods included in the chapter are non-destructive and can be used on packaging that will be released to market.
Probabilistic methods, such as dye testing or visual inspections, are traditional tests frequently used in the pharmaceutical industry. These tests produce more subjective results and are more likely to be influenced by human error or bias. For example, most packaging-related recalls are due to seal defects. When manual visual inspection is used to check for seal defects, a 75-micron channel defect is likely to be detected only 60 percent of the time. Also, inspectors’ ability to detect these defects declines as they spend more time on the task.
Choosing A Test Method
Testing can be either destructive or non-destructive. Peel and burst are measures of a package’s ability to resist destruction. The tests are designed to stretch the package past the point of failure, and are only available in a destructive form. However, nondestructive testing increasingly is becoming the norm for high-risk applications. Not only does it reduce manufacturing waste for higher-value products, but it helps companies obtain more accurate information. This information provides distinct power in addressing critical issues such as container closure integrity. Reliability of data and certainty of test results are key to their implementation.
Stauffer says there is an uptick in interest in testing among the end user companies as they explore new product delivery systems. There are more reliable technologies available today than there were 15 to 20 years ago to test the diverse packaging in the market. The quantitative methodologies have been simplified, validated, and are far more reliable. Ultimately, the need for improved package integrity test methodologies comes down to the identified risk to patients associated with a failure of the container and closure system. The technology has arrived to greatly improve the detection of quality failures. “Every company fights their fires in different ways,” Stauffer says. “Doing nothing is an invitation for critical quality failures.”
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