Automatic inspection and leak test for pharma containers

Ensure container integrity for injectables with high-speed inspection and precise leak detection, crucial for quality assurance in parenteral production lines.

Detects Micro Leaks in Pharmaceutical Containers

The Leakage Tester from TRUKING offers a fully automated solution for detecting micro leaks in pharmaceutical containers. Utilizing high-voltage discharge technology, it inspects closed containers like ampoules and pre-filled syringes for micro pores down to 0.2 μm. Capable of handling various applications from vaccines to diagnostic reagents, it ensures product integrity and compliance with stringent industry standards such as cGMP and FDA. The system is equipped with a servo drive, providing stable and reliable operation at high speeds while minimizing energy consumption. Designed for seamless integration, it can function independently or alongside other inspection systems, with a comprehensive control interface for remote monitoring and data integrity in accordance with 21 CFR Part 11. The machine supports efficient cleaning protocols to maintain sterile conditions. Custom engineering support allows for tailored system configurations to meet specific operational requirements and optimize production efficiency.

Benefits

  • Enhances product safety by ensuring complete leak detection for micro pores as small as 0.2 μm.
  • Reduces manual inspection labor through fully automated operation.
  • Increases operational efficiency with high-speed, continuous processing.
  • Maintains compliance with cGMP and FDA standards, ensuring regulatory adherence.
  • Minimizes contamination risks with robust and easy-to-clean design.

General


Applications
Oral liquid preparations,Lyophilized products,Softbag products,Ampoules,Pre-filled syringes,Traditional chinese medicine,Injectables,Bfs products,Diagnostic reagents
End products
Insulin pre-filled syringes,Vaccines,Cough syrups,Covid-19 test reagents,Vitamin ampoules,Herbal extracts,Freeze-dried pharmaceuticals,Iv solutions in bfs packaging,Parenteral nutrition bags
Steps before
Preparation,Filling
Steps after
Sterilization,Packaging,Inspection,Leak Testing
Input ingredients
vials,ampoules,oral liquids,closed container,bottles,containers with cosmetic defects
Output ingredients
micro pore detected containers,liquid level checked containers,containers with cap color defects,containers with cap scratches,black particle detected containers,white particle detected containers,bottle crack detected containers,glass fragment detected containers,unqualified container
Market info
Truking is known for manufacturing engineered-to-order pharmaceutical equipment, specializing in liquid and solid preparation systems. They have a strong reputation for innovation and quality in the pharmaceutical machinery sector.

Technical Specifications


Leak Detection Accuracy
Better than 0.2 μm
Inspection Vision Precision
40 μm
High Voltage Leak Detection
Nondestructive
Inspect Micro Pores Size
0.2 μm
Automation
Fully Automatic
Control System
Industrial PC
Synchronization
Can be synchronized with inspection HMI
High Voltage Application
Closed Container Inspection
View Angle
360°
Servo Mechanical System
State of the Art
Software Performance
Optimized
Current Measurement
Continuous
Defect Types
Black/White particles,Bottle crack,Liquid level,Glass fragments
Cosmetic Defects Inspected
Cap color,Cap scratches/logo tarnish

Operating Characteristics


Automation level
Fully automatic/PLC
Batch vs. continuous operation
Continuous
CIP/SIP
No CIP/SIP mentioned,manual cleaning implied
Changeover time
Minimal due to automation
High voltage leak detection
Suitable for closed containers
Visual inspection capability
360° bottle view
Leak detection accuracy
Better than 0.2 μm
Control system integration
Synchronized with inspection HMI

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm

Physical Characteristics


Discharge method
Automatic
Control panel type
Industrial PC control

Custom Options


Control panel type
Integrated HMI / Independent Control
Integration possibilities
Compatible with Automatic Light Inspection Machines
Automation level
Fully automatic
Servo drive system
Stable and reliable operation
High voltage leak detection
Nondestructive,integrated with inspection outfeed
Viewing window
360° bottle view