An increasing number of companies, particularly in the pharmaceutical sector, need to inspect their products and packaging using more than one method. Performing different tests on the same product significantly increases the reliability of the results and offers better guarantees on the quality of the drugs the company sells. In fact, international regulations expressly require double testing in certain conditions, such as sterile products, which must be inspected visually and pass an integrity check test under European regulations.

While combining the potential of different test methods increases the precision and reliability of the results (since each test provides different information on product integrity and its preservation), it also constitutes a significant challenge for companies, in both economic and organizational terms. This difficulty can be eased somewhat by using combined machines that perform different types of tests in a single automated process. These technologically innovative and highly efficient solutions are growing in popularity precisely because they resolve many of the issues related to the need for multiple testing.


Combined machines: Types of tests and their applications

In combined solutions, different types of tests are carried out by a single machine that applies different methods, using different technologies in one system. A variety of combinations are possible such as leak detection coupled with headspace gas analysis, leak detection with x-ray, leak detection and NIR, NIR and Visual inspection etc. Bonfiglioli Engineering provides the following solutions:

  • CCIT+AVIVacuum/Pressure Decay + Visual Inspection (VI): this is the most common combination, as it can test a large quantity of products like bottles, vials, BFS etc. This solution ensures a few things: the container is free from leaks; there are no cracks or inclusions; and, that the product inside shows no visible alterations nor particle content. Imagine per V/P decay e VI:

  • CCIT+HGAVacuum/Pressure Decay + Headspace Gas Analysis (HGA): this combination is used to test products for which international regulations make leak detection mandatory and for products that could be damaged by the presence of excessive quantities of oxygen or water vapor inside the packaging. Imagine per V/P decay e HGA:

  • Visual Inspection + Headspace Gas Analysis (HGA): this combination is ideal for inspecting freeze-dried products which, as suggested by USP <1207>, must be tested by HGA to verify that the modified atmosphere in which they are stored has the intended composition. Adding Visual Inspection to HGA ensures that the packaging is not damaged so it will protect the product over its shelf life.



Benefits of combined solutions

A combined testing machine for pharmaceutical products offers numerous advantages over traditional solutions, which require the use of two independent and separate automation systems:

  • Product handling: a combined solution simplifies product handling, as two distinct devices are not required, and products can be tested inside a single machine.

  • Space savings: It saves considerable space in the production plant.

  • Cost savings: A combined system costs less than two individual, independent machines. The initial investment for machine purchase, installation and qualification is lower, as are operating costs, since most of the parts like the control panel, electrical panel etc. are shared by the two machines. This cuts maintenance costs and requires fewer operators to monitor the machine, without impacting efficiency in any way.

  • High speed testing: It works at high speeds even when doing more than one test, eliminating any performance disadvantages.

  • Simple management: A combined machine allows for multiple inspections from a single project, a single installation, and a single supplier: this simplifies personnel training (who learn just one procedure instead of two), spare parts purchases and maintenance management.


The Bonfiglioli Engineering Solution

Our combination solutions take advantage of all the technologies developed by the company that are usually applied to machines performing only one type of test. A combined machine performing both visual inspection and headspace gas analysis, for example, enjoys all the advantages offered by the application of neural networks to visual inspection, since Bonfiglioli Engineering’s technology can be easily applied to combined machines. Similarly, our intuitive Human Machine Interface (HMI) can easily be implemented in a combination solution, simplifying the operator’s work, and guaranteeing optimal results in terms of efficiency and safety.


Case history

The solutions provided by Bonfiglioli Engineering are versatile, even for complex products, or specific requirements, because they are designed to adapt to the characteristics of both the product to be tested and the production line. This is exactly what was done for a customer who required a versatile solution.

The customer’s plant had several lines producing relatively small batches of many different products, both liquid and solid, that were stored in both bottles and ampoules, some of which had to be tested only with Headspace Gas Analysis or with leak tests, and others instead, using both the test methods. The wide variety of product types made it particularly advantageous for the customer to purchase a combined machine, since managing quality control using different machines would be complex.

Bonfiglioli Engineering designed a machine that performs both, leak test and Headspace Gas Analysis (detecting the presence of both oxygen and water vapor). Once the products to be tested have been loaded, the operator simply selects the recipe for the type of test required and waits for the machine to perform the test automatically. We were also able to integrate the machine with another quality control system the customer already had that detects macroscopic product defects like the absence of the cap or visible packaging deformations.

In addition to the flexibility guaranteed by the combined system, customizing the machine allowed us to effectively meet an specific request, and enabled the customer to implement a quality control system that is accurate, fast and easy for the operator to use.

Considering combination inspection solutions for your packaging? Contacts us 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.

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