[P pharmaceutical use] Fukuda pinhole (pseudo-defect/reference test piece)
Pinhole, pseudo-defect, reference specimen, positive control, defective sample, standard setting, validity evaluation, JP18, packaging integrity evaluation.
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
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【Features】 - Pseudo defects with specified hole diameter and length (reference test piece) - Compatible with pressure change leak testing method and liquid immersion testing method - Evaluation of packaging integrity in accordance with JP18 - Material: SUS 304, Ni - Hole diameters: Φ5, 10, 15, 20, 50, 100, others 【Our Strengths】 Pursuing leak detection for 60 years, we are committed to advancing the future of leak testing. We offer optimal leak testers tailored to meet various leak testing needs of our customers. ISO 9001 certified.
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- Evaluation of packaging integrity in accordance with JP18 - Setting of "maximum allowable leakage limit" - Testing for the intrusion of water vapor, oxygen, and microorganisms - Quantification from qualitative testing methods (current leakage standards converted to pore size)
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【 Various Leak Testing Solutions: Air Leak Test / Gas Leak Test (Hydrogen Gas, Helium Gas) 】 We develop, manufacture, and sell leak testing equipment to inspect airtightness and sealing performance. We will propose appropriate testers and devices for each inspection target. 【 Target Industries and Examples of Inspection Targets 】 - Automotive Industry: Engines, FC components, valves and piping, various parts - Electronic Components Industry: Smartphones, keyless switches, various small sensors - Pharmaceuticals / Food / Cosmetics Industry: Bottle containers, syringes, vials, eye drop containers, pillow packaging, PTP packaging We will propose the "optimal leak tester" for each industry. 【 ISO Certification 】JIS Q 9001:2015 (ISO 9001:2015) Head Office Address: 3-16-5 Nukui, Nerima-ku, Tokyo (Postal Code: 176-0021) Phone Number: 03-3577-1111 (Main)
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