Pressure testing machine FY-01

automaticfor syringesfor medical applications

Introduction
The FY-01 Medical Syringe Negative Pressure Tightness Tester is a precision instrument designed to evaluate negative-pressure tightness for disposable syringes, prefilled syringes and non-intravascular catheters. It provides automated control, traceable data and safety functions adapted to GMP-regulated production and QC environments.

Product Features

• 7-inch color touchscreen with intuitive graphical user interface (GUI)
• Automatic constant-pressure gas replenishment to maintain preset vacuum conditions during tests
• High-performance vacuum components for stable and durable operation
• One-button operation for automatic vacuum condition switching, test termination, backflushing and unloading
• Automatic data storage with retention after power-off for traceability
• Multiple safety functions including emergency stop and overload protection
• Integrated micro-printer prints test reports automatically upon completion
• Standard USB interface for convenient data export
• Multi-level user permissions compliant with GMP requirements
• ISP online control and upgrade capabilities for remote adjustment of test functions

Test Principle
Place the syringe or catheter in the fixture, set the vacuum pressure and dwell time, then inspect the sample for bubbles or leaks indicating loss of negative-pressure tightness.

Test Standards

• ISO 7886 – Sterile hypodermic syringes for single use
• GB 15810-2019 – Sterile syringes for single use

Test Applications

• Disposable syringes
• Prefilled (preloaded) syringes
• Non-intravascular catheters and medical tubing

Technical Specifications

• Model: FY-01
• Vacuum degree: 0 ~ -90 kPa
• Accuracy: 0.25% FS
• Adjustable test time: 0 ~ 9999 s
• Negative pressure generation: Vacuum generator
• Required air pressure (not supplied): 0.4 ~ 0.6 MPa
• Port size: Ф6 mm PU tubing
• Power supply: AC 100-240V 50/60Hz (customizable to local requirement)
• Instrument dimensions: 550 x 300 x 300 mm (W x D x H)
• Net weight: 8 kg

Configurations

• Standard: Instrument, Micro-printer, Test fixture

Note
The instrument gas supply port is Ф6 mm PU tubing; customer must provide the external compressed air supply (0.4~0.6 MPa).