International regulations require regular validation of automated systems performing quality control testing on pharmaceutical products. Validation of the test method is a process that verifies the machine's effectiveness and its ability to correctly identify damaged products. It is fundamental to protect final consumers and to give the manufacturer assurance the system is operating correctly and the products meet quality standards.
Bonfiglioli Engineering helps companies validate their testing processes by providing a complete validation package and helping in every phase requiring direct customer involvement. The validation kit allows companies to easily control the correct operation of the machine with respect to the specifications and to certify the verification activities.
The testing process can be verified by using a damaged sample and checking that the sample is correctly identified as non-compliant. This might seem obvious, since CCIT machines are calibrated to identify extremely small holes. However, it can be very difficult to drill such a small hole on the sample to be tested. Holes measuring 55 microns in diameter can be drilled using a calibrated needle, but for smaller holes, more complex solutions are needed, such as high-precision laser systems certified through microscopic verification.
The difficulties do not end here; the hole’s characteristics cannot be determined with certainty. There can be deviations in the size of the opening if the drilled bit is not perfectly perpendicular to the wall of the container, and the temperature difference caused by a laser can deform the edges of the hole, giving it a conical shape. These difficulties also exist when testing rigid products such as glass vials and are exacerbated in flexible packages. In these cases, it is almost impossible to obtain a hole with a predefined size that can be used to test and obtain reliable results.
Mechanical methods or lasers cannot be used to verify the testing machine’s ability to reject samples with tiny holes. While these methods can be used if the diameter of the hole to be measured is relatively large, other solutions are needed for products requiring greater precision.
To validate the testing process effectively for products requiring high sensitivity, the physical principle comparing the flow of fluid through a hole can be used. This principle is described by the Hagen-Poiseuille Equation and correlates an equivalent hole diameter to a known flow. It is also covered by ASTM F2338-09 standard. This method uses a calibrated flow inserted in the pneumatic system as a validation method for Vacuum Decay Method (VDM) and Pressure Decay Method (PDM) testing machines. In this way, a known physical principle to validate the machine and obtain precise and highly sensitive results with no need for any physical object (the artificially pierced sample) can be used.
Bonfiglioli Engineering offers a validation kit that easily introduces a calibrated flow into test chambers. If an abnormality is detected and reported, the automated system can detect holes of a certain diameter, thus validating the results. Calibrated flows are designed to remain stable over time, which means that they are a precise, certifiable, and repeatable verification of correct machine operation.
The validation kit demonstrates that every test chamber can identify expected losses. Therefore, validation via calibrated leak is extremely reliable, and is advised by regulations. This solution makes machine validation safe, allowing companies to perform self-diagnoses and set challenges for the machine, based on their own standard operating procedures.
Contact us to know more about calibrated flows for your specific testing needs.