Why Manufacturers in the Pharmaceutical Industry Should Consider Outsourcing Their Leak Testing

When it comes to the manufacturing industry, leak detection testing is absolutely crucial for developing a safe product that your customers can trust. But, what is leak detection testing? Put simply, leak detection testing refers to the process of testing for leaks in various materials that are used in a wide variety of industrial sectors. In general, leak testing is required across a variety of different industries, including medical and pharmaceuticals, where approximately 150 different products need to be tested for leaks.

Products tested in the healthcare industry range from simple tablet strips and blister packs to lifesaving medical devices that require sterility, and leak testing demands in the pharmaceutical industry are higher than ever. This is why many manufacturers in this sector choose to outsource their leak testing to a dedicated third party. Today, we’re discussing the different types of leak testing available in the medical manufacturing industry, the differences between them, and why you should consider outsourcing your leak detection testing today. 

Why is Leak Testing Required?

There are several reasons why products in the medical and pharmaceutical industry might leak. They include the incorrect use of sterilization methods, poor manufacturing techniques, inferior storage conditions, and even human error. Any leak detected in a pharmaceutical product should not be there and can cause harmful effects to humans.

There are also many different types of products in the medical manufacturing industry that require leak detection testing. Even the smallest leak in these products can lead to contamination, moisture buildup, and even damage to the product itself. The importance of leak testing, which follows a specialized procedure to detect leaks, in pharmaceutical packaging and other medical applications is quite evident.

Types of Leak Detection Testing Available

When it comes to leak detection, there are two main types of testing available: the traditional methylene blue dye and the newer non-destructive testing options. While non-destruction options are definitely growing in popularity, the blue-dye test still remains fairly standard.

Methylene Blue Dye Test: This testing method is typically reserved for leak testing pharmaceutical blister packs and remains the most common approach for these pharmaceutical packaging options. The equipment required for the blue-dye test is relatively inexpensive, and it’s a simple, straightforward testing process that involves placing the blister into a vat with blue dye and water and then visually inspecting for leaks.

Non-Destructive Leak Test options are preferred because they don’t require any disruption to the product or manufacturing operations. This means that the process does not compromise the safety of the product at all, because there are no hazardous materials involved and the product is not damaged during the process. However, there are still several drawbacks to non-destructive testing. The main disadvantage is that the sample is more likely to be contaminated during the test. This contamination may affect the quality of the results as well as the safety of the production process.

Another problem with non-destructive testing is the time duration needed to detect a leak, and the time required to do the leak detection testing itself. Some of the non-destructive methods of leak detection testing require more time than non-penetrable methods. Depending on the product being tested, the environment, or simply personal preference, there are several different types of non-destructive leak testing available to choose from. Some of the most popular include liquid penetrant and ultrasonic testing.

Benefits of Outsourced Leak Testing

While pharmaceutical and medical device leak testing is a necessary component of the manufacturing process, it often comes with some disadvantages. The time and cost associated with the process can be an added expense for some manufacturers, while the strict codes and laws outlined by government regulations can be confusing. This is why it’s best to leave the leak testing process to the professionals.

Properly conducted leak testing will put your product through a series of tests that will really ensure its reliability and safety. The top benefits for outsourcing your leak detection testing to professionals, like Nolek, include:

Boosted Productivity: When you outsource the leak detection process for your medical and pharmaceutical manufacturing product, hundreds of hours of employee time are freed up to focus on other areas of operation. Non-destructive leak testing methods, especially, can be quite time-consuming. Consider outsourcing this tedious process to the ones who’ve dedicated their careers to it.

Increased Safety: The main reason leak detection standards are so strict in the healthcare industry is because people’s actual lives are on the line. If a leak goes undetected, an unsuspecting patient could be seriously injured by a faulty product. This is why you want to ensure that your leak detection tests are always completely accurate and in compliance.

Conclusion

In the pharmaceutical and medical device industry, properly leak testing products is of utmost importance. Patient lives and hospital reputations depend on products with integrity. There are a number of different leak testing options available for manufacturers in the healthcare sector, including traditional destructive testing methods, and the newer, more time-consuming non-destructive solutions. Adhering to strict standards and keeping up with the demands of leak detection can be difficult for manufacturers of any size, which is why outsourcing could be a viable solution.

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