[P pharmaceutical use] Fukuda pinhole (pseudo-defect/reference test piece)

For leak testing of pharmaceutical containers. Pseudo-defects/reference test pieces with specified hole diameter and hole length.

In the pharmaceutical industry, complete sealing of containers is essential for maintaining the quality of pharmaceuticals. Particularly in container inspections for vials and eye drop containers, high precision is required to detect even the smallest leaks. Inadequate containers can lead to degradation or contamination of pharmaceuticals, potentially compromising the safety and reliability of the products. Fukuda Pinholes (pseudo-defects/reference test pieces) can be utilized as positive controls (defective product samples) for standard setting and validation in pressure change leak testing and liquid immersion testing. They contribute to the evaluation of packaging integrity in accordance with JP18, the setting of "maximum allowable leak limits," and tests for the intrusion of water vapor, oxygen, and microorganisms, as well as quantification from qualitative testing methods (current leak standards converted to pore sizes). [Usage Scenarios] - Container inspections for vials, syringes, and eye drop containers - Leak testing for PTP packaging - Evaluation of packaging integrity [Effects of Implementation] - Improved quality control through accurate leak testing - Increased efficiency in standard setting and validation - Assurance of product safety and reliability

Leak Testing EquipmentDefect Inspection EquipmentPinhole detector