Regardless of the type of technology used to perform them, leak tests are not only required by international regulations governing the pharmaceutical industry but can also offer great benefits to the companies using them.

Angela Rosignoli, Bonfiglioli Engineering’s Validation and Documentation Team Manager explained the risks involved with non-integral packaging and international regulations that serve as guidelines in leak detection. She also underscored some of the main benefits pharmaceutical companies can obtain when they install technologically advanced leak test machines, relying on the expertise of an experienced partner, providing reliable and customised solutions.


Risks related to leaks in pharmaceuticals

The presence of leaks in packaging is a serious risk for all products intended for human consumption but is especially dangerous when the container to be tested contains pharmaceutical products. 

A leak in a sealed vial, syringe or bottle can compromise its contents, causing contamination due to the entry of inert particles, or alteration of the drug’s active ingredient due to contact with oxygen, for example. 

The risks are even greater in the case of sterile products: the lack of proper packaging seal compromises the content, making it unusable and potentially harmful for the person using it. 

If the leak is significant enough to allow a certain percentage of the drug contained in the packaging to be released, the patient may unknowingly take a lower dose of the active ingredient than prescribed.


Leak tests and international regulations and standards

International guidelines applied to all markets—such as the US regulation USP chapter 1207 and European Medicines Agency Guidelines—define which tests should be conducted to check for leaks in ready-to-sell pharmaceuticals and establish which types of drugs must be tested at 100% of production and which can be tested in by sampling However, any company can decide to test all its products regardless of statutory requirements to guarantee safe products to patients and consumers and protect itself against the risk of recalls. 

USP 1207 guidelines also suggest implementing deterministic rather than probabilistic tests, such as the Vacuum Decay Method technology, for example. The guidelines encourage such tests because they are non-destructive (so they can be applied to the entire production), repeatable and because their results do not necessarily require an assessment by a human operator. 




Benefits of leak testing

Leak tests can produce extremely positive effects for the company implementing them.

Leak detection and packaging integrity tests protect the company from the risk of harming the patients using the drugs. They also ensure it sells safe, undamaged, and uncontaminated products that safeguard the health of the end consumer and the company’s brand and image.

Leak tests can also identify eventual production inefficiencies, allowing the company to correct malfunctions early, thus avoiding not only potential product recalls but also of wasting large quantities of product.

But these are not the only benefits of implementing technologically advanced leak tests. These tests can provide an opportunity to develop innovative packaging and to make changes for positive long-term effects. Here are some examples. A leak test machine accurately verifying the entire production allows the company to use thinner vials, guaranteeing significant raw materials savings over time without compromising product safety. Similarly, a machine providing reliable results even for packaging with unconventional shapes or materials, operates optimally even with innovative containers, which are becoming increasingly common on the pharmaceutical market.

To make this possible, however, companies need an experienced partner that provides reliable machines and technologies and works in synergy with the customer, understanding their needs and providing advice on all areas, from technologies to regulations. Drawing on its long experience in the pharmaceutical sector, Bonfiglioli Engineering can advise its customers on the most suitable machine for their product, develop customized solutions and provide assistance through the entire life cycle of the product.

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.

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