The primary goal of any packaging system is to ensure packages integrity and prevent inside content from being contaminated by external elements. To maintain the integrity of the packages, it is important to employ sophisticated packaging validation processes. This is especially true for high-risk packaging applications such as that encountered in pharmaceutical and class III medical devices. Pharmaceutical companies are ensuring that they make use of the most reliable test methods as content contamination can have significant detrimental effect to the end users. Visual tests that were commonly used are now being replaced by a more-reliable non-destructive quantitative test system. New test methods are also being developed to offer highly accurate results.
In view of the emphasis laid on packaging methods, a new set of guidelines to determine the integrity of sterile product packaging was published in February 2016. The guidelines put forth detailed best practices that can be used for container closure integrity testing and how a company can make use of methods that best suit the needs of their industry. It suggests that manufacturers adopt deterministic test methods wherever possible to get accurate results. With the guideline, manufacturers have a list of the testing capabilities that can be employed.
Deterministic and Probabilistic Testing Methods:
The testing methods can be divided into the following two types:
1. Deterministic
2. Probabilistic
The deterministic methods are less subjected to errors as compared to the probabilistic method. They utilize of wide ranges of instruments that provide quantitative results and offer better statistical and analysis tools. Some of the widely used methods include but not limited to: vacuum decay testing, high-voltage leak detection and more.
In contrast, the probabilistic methods include the traditional testing methods such as dye testing and visual inspection. The results are subjective in nature with decent chance for errors. For example, the probability of locating a minor seal defect with the visual inspection method is very low. Moreover, it is impractical to have an operator stand by for eight hours a day for checking these packages using this method as the ability of an individual to detect such leaks will definitely decline over time.
With the new guidelines, it is evident that the TGA wants to ensure that companies are making use of the most reliable test methods which have been thoroughly evaluated and assessed.
The Importance of Testing:
A defective asset is a liability. Product recall, when occurs, not only damages the company reputation but also impacts the operational activities of the company. The latter effect is more pronounced when the issues cannot be resolved in time. The importance of testing lies in the fact that it is possible to figure out a leak and take the necessary actions to fix it under a reasonable amount of time.
Choosing the best test method:
For high-risk applications, non-destructive testing is the preferred option. It reduces wastage as packages can be returned to the production line upon testing and also helps companies to get better results. There are reliable technologies available and it is possible for a company to choose from the quantitative methodologies and employ one that best caters to their needs. Since every process is different, understanding the precise needs of your process and the sensitivity required will help you pick a test method that works best.
At Sealtick, we offer a range of systems that are designed to offer unmatched reliability. With our leak test equipment, manufacturers have succeeded in achieving consistent product quality and testing efficiency in the last 15 years. We have a range of options to choose from and you are sure to find the right leak testers for your application. If you wish to know more about our testing systems, feel free to reach out to our team. We will be glad to help. You can email us at sealtick@bestech.com.au. You can also call us on +61 3 9540 5100.
