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Standard | Focus Area |
---|---|
ISO 7886 | Syringe design and leakage criteria |
ISO 11608 | Sterile single-use syringes |
USP <788> | Particulate matter in injectables |
The tester uses a pneumatic system to apply positive pressure to syringe barrels while sealing the plunger. A high-precision pressure transducer monitors decay rates, with algorithms compensating for temperature variations. Automated valves control test cycles, ensuring repeatable results across production batches.
This integrated solution enables manufacturers to validate syringe integrity efficiently, meeting FDA and MDR requirements while ensuring patient safety through robust seal quality control.
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