Rubber Stopper Puncture Debris Tester
The Rubber Stopper Puncture Debris Tester is a precision instrument designed to evaluate the puncture resistance and debris generation of rubber stoppers. It is suitable for various vial types including syringes, ampoules, cartridge vials, and infusion bottles. The device ensures accurate testing of stopper performance under repeated puncture conditions, providing reliable data for quality control and regulatory compliance.
Application
You can use this instrument to test:
(1) Rubber stoppers of syringes, vials, ampoules, and infusion bottles
(2) Puncture resistance of injection ports and implanted drug delivery devices
(3) Debris generation during repeated puncture events
(4) Evaluation of stopper materials for pharmaceutical manufacturing and packaging
(5) Research and development of new stopper designs or formulations
Standards
(1) YY 0332-2011 – Implantable Drug Delivery Devices
(2) YY 0581.1-2011 – Infusion Connectors Part 1: Puncture-Type Connectors (Heparin Cap)
(3) YBB00152004-2015 – Chlorinated Butyl Rubber Plungers and Seals for Pen Injectors
(4) YBB00332004-2015 – Puncture Debris Test Method for Injection Stopper Seals
(5) YBB00052005-2015 – Halogenated Butyl Rubber Stoppers for Sterile Powders for Injection
(6) YBB00232004-2015 – Pharmaceutical Synthetic Polyisoprene Seals
(7) YBB00162004-2015 – Brominated Butyl Rubber Plungers and Seals for Pen Injectors
Parameters
| Item | Specification |
|---|---|
| Testing Range | 0.010–50.00 N (Optional 100 N) |
| Accuracy Class | 0.5% (Class 0.5) |
| Resolution | 0.001 N |
| Testing Speed | 0.05–600 mm/min |
| Speed Accuracy | ±1% |
| Dimensions | 340 × 230 × 320 mm |
| Weight | 15 kg |
| Power Supply | 220 V, 50 Hz |
Features
(1) High-precision force measurement for accurate puncture and debris testing
(2) Adjustable speed and displacement settings to simulate real puncture conditions
(3) XY-module for precise positioning of puncture needle
(4) Clamping fixture for secure holding of puncture needles
(5) Easy-to-operate interface for repetitive puncture testing
(6) Ability to count and inspect debris under 5× magnification
Accessories
(1) Main tester unit
(2) XY-module positioning system
(3) Needle clamping fixtures
(4) Power cord
(5) Calibration weights and tools
Maintenance Information
(1) Clean the needle and syringe fixtures after each test to prevent contamination.
(2) Regularly inspect XY modules and guide rails for smooth movement.
(3) Verify calibration of force sensors periodically to maintain accuracy.
(4) Store the instrument in a dry, dust-free environment.
(5) Check power connections and electrical components regularly for safety.
FAQ
(1) What is this product?
It is a tester for evaluating puncture resistance and debris generation of rubber stoppers.
(2) What is this product used for?
You use it to measure how rubber stoppers perform under repeated needle punctures and to count any debris produced.
(3) What is the working principle of this product?
A puncture needle is repeatedly driven through the stopper using an XY-module; displacement and force are controlled, and debris is collected for inspection.
(4) Why is this product important?
It ensures stopper integrity, safety, and regulatory compliance, reducing contamination risks in pharmaceutical products.
(5) What industries is this product suitable for?
Pharmaceutical manufacturing, packaging quality control, and medical device R&D.
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