01
Product Overview
The TrueCARE™ Marking & Inspection System is a fully automated inline solution designed for batch code printing, OCR/OCV verification, and quality inspection of pharmaceutical vial aluminum seals. The system integrates a high-speed vial handling mechanism, Continuous Inkjet (CIJ) printing technology, industrial vision inspection, and automatic rejection to ensure accurate batch identification and complete traceability.
Designed for pharmaceutical manufacturing environments, the system performs batch code printing, code verification, print quality inspection, and rejection of non-conforming vials at production line speeds up to 220 vials per minute. The integrated TrueVISION™ Software Platform provides advanced OCR/OCV inspection, electronic records, audit trail functionality, and 21 CFR Part 11 compliance.
02
Technology Used
- Printing Technology
- Continuous Inkjet (CIJ) Printing Technology.
- Non-contact coding and marking.
- High-speed variable data printing.
- Real-time synchronization with conveyor movement.
- Suitable for alphanumeric batch coding on vial seals.
- Machine Vision Technology
- High-speed industrial vision inspection.
- GigE camera communication architecture.
- OCR/OCV-based code verification.
- Advanced image acquisition and processing.
- Real-time print quality analysis.
- TrueVISION™ Software Platform
- TrueVISION™ is TrueCARE's advanced machine vision software suite developed for pharmaceutical inspection applications.
- Software Modules
- OCR Character Recognition
- OCV Character Verification
- Product Recipe Management
- Batch Reporting
- Rejected Image Management
- User Access Management
- Audit Trail & Electronic Records
- Machine Diagnostics & Monitoring
- 21 CFR Part 11 Compliance
- Software Features
- Multi-level user access rights.
- Password-protected login system.
- Administrator-controlled user management.
- Batch-wise report generation.
- Product template save/load functionality.
- Rejected image storage and retrieval.
- Automation Technology
- PLC-based machine control architecture.
- Sensor-based synchronization.
- Encoder feedback for print positioning.
- Pneumatic reject actuation.
- Industrial PC-based inspection platform.
03
Standard Features
- Automated Vial Handling
- Infeed Turntable for Continuous Vial Feeding.
- Vial separation and controlled loading mechanism.
- PLC-based machine automation.
- Sensor-based operational interlocks.
- Continuous inline operation with existing production lines.
- Suitable for vial sizes from 2 ml to 100 ml.
- CIJ Batch Code Printing
- Integrated Continuous Inkjet (CIJ) printer.
- High-speed batch code printing on vial aluminum seals.
- Batch number, manufacturing date, expiry date, and other variable data printing.
- Encoder-based print synchronization.
- Suitable for continuous pharmaceutical production lines.
- Consistent print quality at high operating speeds.
- Vision Inspection Functions
- OCR (Optical Character Recognition) verification.
- OCV (Optical Character Verification) inspection.
- Real-time printed code validation.
- Master data comparison and verification.
- Automatic rejection of defective vials.
- Defect Detection
- Missing print.
- Smudged print.
- Incorrect batch code.
- Mismatch against approved master value.
- Unreadable or distorted characters.
- Automatic Rejection System
- Pneumatic rejection mechanism.
- Locked reject collection bin.
- Positive removal of non-conforming products.
- Rejection traceability through image storage.
- Compliance & Data Integrity
- 21 CFR Part 11 compliant software.
- Electronic records management.
- Audit trail support.
- User authentication and access control.
- Batch-wise production reporting.
- Secure rejected image archiving.
04
Technical Specifications
| Parameter | Specification |
|---|---|
| Application | Batch Code Printing & OCR/OCV Verification on Vial Seal |
| Printing | Maximum 8 characters Batch Number |
| Inspection Speed | Max. Up to 200 Vials/Minute |
| Machine | • Infeed Turntable • Vial Separation Unit • Suitable Conveyor System for Vial Transfer • Pneumatic based Rejection System • Rejection Bin with Lock-N-Key • Control Panel • SS Structure • Audio-Visual Buzzer |
| Printer | • Videojet Make CIJ Printer • Including • Printer Head and Unit, Photo Sensor and Mounting, Encoder with Mounting |
| Software | TrueVISION™ (Licensed Software for OCR-OCV – Batch Number Verification) |
| Vision System Hardware | • Camera: 1.6 Mega-Pixel Resolution, GigE, CMOS • Camera Make: Retina-Vision • Lens: 12mm, 5.0 MP • Light: Area bar-light – Diffused White |
| Operating System | Industrial Computer System • Processor: i7, 9th Generation or Above • RAM: 8GB RAM • Storage: 480GB SSD • OS: Windows11 IoT, 64Bit • 15.6” LED Display |
| Detailed Features of Software with 21 CFR Part 11 Compliance | Access Levels & Privileges • Different levels with configurable privileges • Administrators have privileges for user management activities. User Management • The system has the provision of allotting unique Alpha-numeric combination of username with password protection. • Administrators can create/Edit/ Delete/Enable/Disable users and user roles. Security Policies • The System will be password protected • Password complexity (Alphanumeric & special character) • Password minimum length (6 characters) • Password aging (flexible to change by Administrator) • Password change (individual or Administrator) • User accounts should be locked after specific consecutive multiple incorrect log-in attempts (Number of failed Login attempts configurable) • System should auto logo off when it is in idle condition for specified time period Reports • The system generates non-editable reports for all the required data and should be human readable. |
| Utility | Power: Single Phase, 220V, 50 HZ (Note: UPS power supply shall be required for System Operation) Compressed Air: 3 CFM @ 3-4 Bar |