Inspecting the integrity of drug packaging is a complex task that requires customizable machines that take into account international regulations, the specific characteristics of the products to be inspected, the needs of the line on which they will operate, etc.
Checking packaging integrity: Various testing methods
Bonfiglioli Engineering has been offering such machines to the pharmaceutical industry for almost 50 years. Our equipment is designed to achieve top performance and to be integrated efficiently into our customers’ processes, with innovative control systems that guarantee the high quality standards required by the pharmaceutical industry in line with international regulatory requirements.
To reach these objectives, Bonfiglioli Engineering offers machines that use several methods to inspect packaging integrity, including:
- Headspace Gas Analysis: This non-destructive technique detects the presence of certain gas molecules in a container's headspace (i.e., in the space not occupied by the product itself). The amount of gas present can be determined by analysing how target gas molecules absorb laser light, so that any products with unexpected values can be eliminated. If, for example, the inspection shows that there is more oxygen than expected, the container might be damaged or not properly sealed. So, there is a risk that the product inside will be subjected to oxidation. Therefore, the non-conforming container must be removed from the line, which the machine can do automatically.
- Automatic Visual Inspection: This technique uses high-resolution cameras to photograph the product to be inspected and send the images to a cluster PC that analyses the data. The software designed by Bonfiglioli Engineering uses neuronal networks (artificial intelligence) to process images and determine which ones include non-conformities. The software can detect cosmetic defects, such as container flaws or an incorrect fill level, as well as defects related to content contamination by particulates or foreign objects, which pose a GMP risk.
- Vacuum Decay Method: This technology creates a vacuum outside the packaging to detect leaks in containers that should to be sealed. The products to be inspected are placed in a test chamber in which a vacuum is created. A certain pressure increase generated by an abnormal flow of air leaving the packaging means that the product is non-conforming, so it is removed from the production line.
- Lid Deflection: This technology uses the concept of a bulging lid when a hermetic product is inserted into a hermetic chamber and subjected to a vacuum on the outside.
When the product has been introduced in the test chamber in which a vacuum is generated, the sensors analyse lid deformation, which must be within a certain range. If the lid has an abnormal and unexpected motion, the packaging might not be closed properly or the sample might be leaking and should be discarded.
Why are pharmaceutical packaging quality and safety controls so important?
Each of the above methods investigates a different aspect of the packaging being tested. While the expected outcome at the end of the analysis is always the same – eliminating from the production line any products with characteristics not meeting the required quality standards – finding the most suitable test method is essential to achieve optimal results in terms of analysis speed and reliability. So, it is important to remember that Bonfiglioli Engineering can develop combined machines that perform two or more types of inspection in sequence on the same product samples. This increases safety margins and ensures no damaged or compromised products are sold.
When determining which test method is best suited to analyse a specific product, it is important to consider a number of factors, including:
- the packaging material
- the packaging shape and colour
- the production line’s analysis performance and speed needs
- international regulatory requirements
- the characteristics of the production line and of the plant
There are certainly many elements to consider and their importance can vary from customer to customer, but there are also some general elements that it may be important to consider when deciding which method to use. To find out more about our customized solution, speak to an ispection expert today.
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.
