X-ray inspection module for pre-filled syringe needles

Ensure sterility and product integrity in high-speed syringe production by detecting defects in needle geometry, crucial for auto-injector compatibility and preventing complications during medical applications.

Inspects Syringe Needle Geometry and Detects Defects

The CUBE XRS 500 from WILCO AG is an X-ray syringe needle inspection module designed to enhance precision in pharmaceutical production lines. This equipment ensures the integrity and specification compliance of needles in pre-filled syringes, crucial for safe usage in applications like insulin delivery and chemotherapy. It operates by rotating syringes 360 degrees during inspection, capturing high-resolution images analyzed by advanced vision systems to detect defects and assess needle geometry. Capable of integrating into existing syringe production lines and supporting high-speed operations of up to 500 units per minute, the CUBE XRS 500 meets GMP guidelines and 21 CFR part 11 compliance. Its toolless format changeover facilitates easy adaptation to various syringe sizes, making it ideal for sterile liquid pharmaceuticals and applications where sterility is paramount. Additionally, it is engineered for aseptic environments, featuring static optical paths and non-destructive testing methods, ensuring maintenance of product integrity and safety.

Benefits

  • Enhances product safety by ensuring needle integrity and preventing sterility breaches.
  • Increases production efficiency with high-speed inspection of up to 500 syringes per minute.
  • Reduces maintenance time and errors with toolless format changes for various syringe sizes.
  • Complies with regulatory standards, ensuring seamless GMP adherence and 21 CFR part 11 compliance.
  • Optimizes integration in sterile environments with non-destructive and aseptic design.

General


Applications
Iv bags,Sterile liquid pharmaceuticals,Vials,Pre-filled syringes,Auto-injectors,Pharmaceuticals
End products
Parenteral nutrition iv bags,Insulin syringes,Vaccine pre-filled syringes,Epinephrine auto-injectors,Lyophilized drug vials,Biopharmaceutical injectable syringes,Chemotherapy pre-filled syringes
Steps before
Assembly of pre-filled syringes,Needle attachment,Tip-cap assembly
Steps after
Line integration,Final assembly,Sterility inspection
Input ingredients
pre-filled syringes,sterile liquid pharmaceuticals
Output ingredients
high-resolution images,360° image of syringe,needle geomerty inspection,bent needles detection,needle hooks detection
Market info

Technical Specifications


Automation
Non-destructive inspection process
Inspection Speed (Output)
Up to 500/min
Detection Type
X-ray
Image Resolution
High-resolution images
Inspection Coverage
360° inspection
Needle Geometry Inspection
Length,inclination,position
Image Processing
Latest image processing algorithms
Integration Capability
Line integration capability with production lines
Compliance
Designed according to GMP guidelines
Data Handling
Compliance with 21 CFR part 11
Changeover
Toolless format changeover
Aseptic Area Use
Designed for use in aseptic areas
Compatibility
Applicable for multiple syringe sizes

Operating Characteristics


Working mechanism
X-ray inspection
Integrated steps
360° rotation and high-resolution image capture
Batch vs. continuous operation
Inline Continuous
Automation level
PLC
Output speed
500 syringes/min
Data handling
Compliance with 21 CFR part 11
Changeover time
Toolless format changeover
CIP/SIP
Designed for use in aseptic areas

Product type Characteristics


Defect Inspection Type
Needle defects,geometry

Physical Characteristics


Machine footprint
Compact
Syringe size compatibility
Multiple sizes
360° inspection
Yes
Static optical path
Yes

Custom Options


Control panel type
Touchscreen / Push button / HMI
Integration possibilities
Syringe production lines / WILCO AVI system
Inspection technology
X-ray system
Handling unit
360° rotation
Image processing tools
State-of-the-art algorithms
Compliance,Standards
21 CFR part 11 / GMP guidelines
Format changeover
Toolless
Operating environment
Aseptic area