Cork Penetration and Fragment Detection Device
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Web: standard-groups.com
The rubber stopper puncture debris detector is a device specifically used to detect the number of debris generated during the puncture process and the puncture force of rubber stoppers (especially those for injectables). The following is a detailed description of its main uses, compliance standards, and technical parameters:
Compliance Standards
- YBB00332004 - 2015 Determination of Puncture Debris of Rubber Stoppers and Gaskets for Injectables - YBB00322004 - 2015 Determination of Puncture Force of Rubber Stoppers and Gaskets for Injectables - GB 8368 - 2018 (May involve relevant standards for packaging materials, but the specific details need to be determined according to the equipment's intended use and the information provided by the manufacturer) These standards specify in detail the test methods for the puncture debris and puncture force of rubber stoppers, specimen preparation, test conditions, etc., providing a unified standard for the use of the detector.
Main Uses
The main purpose of the rubber stopper puncture debris detector is to evaluate the puncture debris - generating performance and puncture force of rubber stoppers to ensure they meet relevant standards and requirements. Through testing, rubber stoppers with puncture debris issues can be promptly identified and removed, preventing unqualified products from entering the market, thus safeguarding the safety and effectiveness of drugs. This device is widely used in the medical, pharmaceutical, and packaging industries, and is of great significance for ensuring drug quality and patient safety.
Technical Parameters
- Puncture Force Range: Generally, it can reach 0 - 200N, and the specific value varies depending on the equipment model and brand. This range covers the testing needs for most rubber stopper puncture tests.
- Control System: PLC control systems are mostly adopted to achieve precise control and data recording. The PLC system is characterized by high stability and reliability, ensuring the accuracy and traceability of the testing process. - Operation Interface: Equipped with a 7 - inch touch - screen operation interface, which supports Chinese - English switching for simple and intuitive operation. The touch - screen interface allows operators to easily set testing parameters, monitor the testing process, and view test results. - External Dimensions: Approximately 500mm×500mm×450mm (The specific dimensions may vary depending on the equipment model and brand), making it easy to place and move. The compact design enables the equipment to be used in different production sites and laboratories. - Puncture Speed: It can be set arbitrarily within the range of 0 - 100mm/min, and the design value range can reach 0 - 200mm/min. Different puncture speeds can simulate different puncture conditions, allowing for a more comprehensive evaluation of the puncture performance of rubber stoppers. - Test Materials: Applicable to the puncture debris performance testing of rubber stoppers for various specifications of vials, ampoules, cartridge vials, infusion bottles, etc. Meanwhile, the equipment also has the ability to customize test fixtures for different samples to adapt to various specifications of specimens. - Data Recording and Processing: The equipment can automatically record test data and generate test reports, facilitating subsequent quality traceability and analysis. Some equipment also supports remote data uploading and cloud storage functions, making the management of test data more convenient and efficient.
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