International regulations and GMP in many countries increasingly recommend implementing deterministic and non-probabilistic testing for the quality control of products placed on the market. In this regulatory context, more and more companies—both pharmaceutical and non—are choosing to use automated leak tests to check the integrity of their product packaging, opting for a solution that increases both the efficiency of their production line and the quality of what they sell. 

But what key questions should you ask before you decide to implement automatic leak testing? How do you choose the best test method for your production line or your company? 

 

Why is it useful to test the integrity of products before marketing them?

Leak testing allows you to ensure the quality of the products you market.

By testing packaging integrity, the manufacturer can assure consumers that the product they are going to use is not damaged or contaminated, which means that all its quality characteristics have been preserved. This is important in every industry, especially when the product in question is a life-saving drug, an injectable product that must be used at a precise dose or a medical device like an IV bag. Failure to guarantee package integrity can impact consumer health significantly. This is why leak tests are essential to ensure that patients receive quality products.

Automated leak tests ensure the quality of the products placed on the market, minimizing the risk of recalls which damage both the company’s bottom line and its image and reputation. Automatic testing can also improve the production process by reducing the number of false rejects and increasing yields.

 

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Is testing 100% of production really cost effective?

Leak tests performed on the entire production are the only tool offering the manufacturer the certainty that all the products have been inspected and are of superior quality. Test methods based on spot checks provides no guarantees in this respect and can lead to products being considered compliant despite not actually meeting the standards. Conversely, if the sample test detects a non-compliant product, the entire production lot must be discarded, even if the rest of the lot is perfect. Identifying non-compliant containers before they leave the line ensures the integrity of your full output and can also help identify production problems early in your process. In this way, testing every container produced protects your investment in raw material and final inventory.

 

How reliable are automatic leak tests?

Automatic leak testing is highly reliable and can provide much more accurate results than any manual test. The equipment performing the tests can identify micro-holes with a diameter of 5 microns (or even smaller for some types of packaging), guaranteeing a much higher level of accuracy than manual testing.

 

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Do automated tests slow down production? Can they be performed on lines operating at high speeds?

Automatic leak testing can be done on any type of production line, and the testing equipment is designed and sized for the expected production speed and characteristics of the line. Bonfiglioli Engineering offers its customers a variety of products ranging from manual-feed machines suitable for inspecting small product lots to fully automatic equipment capable of performing 800-1000 tests per minute (speed can be influenced by the type of test, the size of the product to be tested, the material and shape of the container, as well as many other factors). 

The testing machine’s design is always based on the customer's needs and on the characteristics of the production line. This ensures that it can meet both, the needs of companies requiring hundreds of tests per minute and those needing to check only a few dozen products, while providing accurate quality assurance.

 

What is the average life expectancy of a leak testing machine? What maintenance does a machine of this type require and how long does it last?

Like any industrial equipment, leak testing machines must be serviced on a regular basis, but they are designed to operate efficiently for a very long time.

Bonfiglioli Engineering machines are designed to last more than 30 years, and they can be upgraded periodically by replacing certain mechanical or electronic components with next-generation parts. This ensures that our machines operate as efficiently as possible for decades, avoiding obsolescence and consistently maintaining high performance in terms of reliability, stability, and ease of use.

 

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Automatic leak testing enables you to ensure the integrity of every piece that leaves your production line. Bonfiglioli Engineering can work with you to develop an efficient, cost-effective leak testing solution that integrates with your line, protecting your investment for years to come.

 

We are not just a machine manufacturer. We are your trusted partner for packaging integrity testing and analysis through feasibility studies, technical expertise, validation packages, product handling and custom-built solutions.

Contact us today