Pharmaceutical and cosmetic quality control regulations are progressively stringent regarding the manufacturing and marketing of all kinds of products. These standards help ensure manufacturers are selling safe and controlled products that will maintain their attributes throughout their shelf life, protect both consumer health and manufacturers.
The types of test required depend on the product and packaging. Some products are relatively easy to test, which others present various challenges related to both the type of packaging (in the case of pre-filled syringes) and the contents (as in the case of ready-to-use parenteral drugs). Products with high viscosity or a high protein concentration are particularly difficult to test without appropriate technologies and proven know-how.
The challenges of testing viscous and high-protein products
Testing viscous products is problematic because holes in the container can be hidden by the product itself.
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High surface tension or the presence of complex protein chains inside the product can temporarily plug a hole, preventing leakage. This would compromise leak test results, with the machine passing products that are defective.
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The characteristics of these products also mean that liquid evaporation cannot be used for testing as it is for products with lower viscosity tested in a vacuum.
Therefore, testing products of this type is a remarkably complex challenge for manufacturers, who need effective test methods to avoid selling “false positives”, i.e., products that have passed the test but are not actually up to standard.
These difficulties are not exclusive to drugs, but also extend to other types of products, such as highly viscous cosmetics containing hyaluronic acid.
Bonfiglioli Engineering expertise in testing complex products
Over the years, Bonfiglioli Engineering has developed leak testing solutions that guarantee reliable and repeatable results for products that are particularly complicated to analyze. Several proven technologies can even be combined in a single test for these types of products like a combination of Headspace Gas Analysis with Automatic Visual Inspection.
By uniting technologies and performing numerous checks on every single sample, the product’s integrity can be verified, rejecting false positives, and guaranteeing effective and precise testing even for products with high viscosity.
Each product is unique and Bonfiglioli Engineering studies each product type before suggesting the best inspection solution for space and cost savings and avoiding false rejects or a combination of these so that you can rest assured your product is safe to use and will also last effectively through its shelf life.
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Go beyond leak detection with: The X-factor of Bonfiglioli Engineering leak test machines. This article shows how Bonfiglioli Engineering machines provide holistic solutions that help maintain efficiency throughout the life of the equipment.
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.
