Leak tests: What are they for and what benefits do they offer to pharmaceutical companies?

Regardless of the technology used to perform them, leak tests are not only required by international regulations governing the pharmaceutical industry but also offer significant benefits to the companies that implement them.

Angela Rosignoli, Bonfiglioli Engineering’s Validation and Documentation Team Manager, explained the risks associated with non-integral packaging and the international regulations that serve as guidelines for leak detection. She also highlighted the key benefits pharmaceutical companies can gain by installing technologically advanced leak testing machines and partnering with an experienced provider that delivers reliable, customized solutions.

Risks related to leaks in pharmaceuticals

The presence of leaks in packaging poses a serious risk for all products intended for human consumption, but it is particularly dangerous when the container holds pharmaceutical products.

A leak in a sealed vial, syringe, or bottle can compromise its contents, leading to contamination from the entry of inert particles or alterations to the drug’s active ingredient due to exposure to oxygen, for example.

The risks are even greater for sterile products. A compromised packaging seal can render the contents unusable and potentially harmful to the person using them.

If the leak is significant enough to allow a portion of the drug to escape from its packaging, the patient may unknowingly receive 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, European Medicines Agency Guidelines, and Annex 1—define which tests should be conducted to check for leaks in ready-to-sell pharmaceuticals. They also establish which types of drugs must be tested at 100% of production and which can be tested by sampling. However, any company can choose to test all its products, regardless of statutory requirements, to guarantee safe products for patients and consumers and to protect itself against the risk of recalls.

USP 1207 guidelines also recommend implementing deterministic rather than probabilistic tests, such as the Vacuum Decay Method technology. These 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 detection and packaging integrity tests protect companies from the risk of harming patients who rely on their drugs. They also ensure the sale of safe, undamaged, and uncontaminated products, safeguarding both consumer health and the company’s brand and reputation.

Leak tests can also help identify production inefficiencies, allowing companies to detect malfunctions early. This not only helps prevent potential product recalls but also reduces waste of large quantities of product.

However, these are not the only benefits of implementing technologically advanced leak tests. These tests can also create opportunities for innovative packaging development and long-term improvements. For example, a leak test machine that accurately verifies the entire production line allows companies to use thinner vials, leading to significant raw material savings over time without compromising product safety. Similarly, a machine capable of providing reliable results even for packaging with unconventional shapes or materials ensures optimal performance with innovative containers, which are becoming increasingly common in the pharmaceutical market.

To achieve these benefits, however, companies need an experienced partner that provides reliable machines and technologies while working in close collaboration with the customer. This includes understanding their needs and offering guidance on everything from technology to regulatory compliance. Drawing on its extensive experience in the pharmaceutical sector, Bonfiglioli Engineering helps its customers select the most suitable machine for their products, develop customized solutions, and receive support throughout the entire product lifecycle.

Citations

This article is inspired by information from Bonfiglioli Engineering.

1. Bonfiglioli Engineering. “Guide to defects detected by Visual Inspection” - Bonfiglioli Engineering, BONFIGLIOLI ENGINEERING S.r.l