Overview: Inspecting the integrity of pharmaceutical product packaging and protecting healthTesting pharmaceutical products has always been a central step in the industrial process leading to their commercialization. Checking the proper seal of the packaging plays a fundamental role in manufacturing. Regardless of the type of product, it is essential to check that its container has no holes, micro-holes, cuts, incisions or inclusions and that the sealing process was completed properly. Non-compliant packaging can pose a number of risks, including:
- Risk of dispersion of some of the product, which can lead to errors in the dosage of the active ingredient administered to the patient or to the sale of completely unusable drugs
- Risk of alteration and deterioration of the active ingredient, due to the presence of inert particles, moisture or gases inside the packaging that could cause oxidation and damage the product.
- Risk of contamination due to an error when closing the packaging which compromises the content, making it unusable and potentially unsafe for the user. This could indicate a more general malfunction of the production line with potentially serious consequences for the entire process.
Pharmaceutical product packaging inspection methods including Headspace Gas Analysis, Automatic Visual Inspection, and Vacuum Decay & Pressure Decay testing
Pharmaceutical packaging controls have developed significantly over the years. In the past, products were generally inspected using sample analysis. A few products were checked for packaging tightness, and if defects were found, the entire lot to which the defective product belonged was eliminated.
These tests were almost always destructive, which created many difficulties for manufacturers:
- Loss of all tested samples: even compliant products had to be eliminated because they were damaged during analysis.
- Loss of compliant products contained in the lot from which the non-compliant tested sample was extracted
- Risk of selling non-compliant products that had not been tested
New leak testing methodologies have been developed to meet the pharmaceutical industry ‘s need to limit waste and to meet international regulatory authorities’ increasingly stringent demands. These new methods are not destructive and can be used for all products ready to be sold. This has significantly improved drug safety, reducing waste without endangering the health of future product users in any way.
Today’s analysis methods test 100% of products that have already been sealed, analysing a series of parameters that identify potential damage to the packaging. The most common types of test, are available in the machines designed, supplied and installed by Bonfiglioli Engineering
This test method inspects the integrity of a sealed product’s packaging by detecting the presence of certain gases in its “headspace”, i.e., the space inside the packaging not occupied by the product. The test checks that the sealed packaging contains no gas or moisture that could contaminate or damage the active ingredient, or whose presence would indicate the occurrence of an unexpected event at some point in the industrial process. The analysis is based on a tunable diode laser absorption spectrometer (TDLAS), which uses laser diodes tuned to the frequency of the molecule being sought. Once it has been tuned to the frequency of oxygen, carbon dioxide or nitrogen, the spectrometer measures the level of absorption of the laser to determine the quantity of that molecule inside the packaging and to check that the value matches the expected value. For products stored in a protective nitrogen atmosphere, for example, HGA ensures that the amount of oxygen present in the head space of the container is minimal, indicating that the nitrogen cleaning process has been completed successfully and there is no risk of product oxidation.