FDA Compliant BFS Labeling Machine with CCD Camera Inspection

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Specifications

Application
Pharma, Bio, Supplement
Software & Digitalization
Wincc
Documentation
IQ,OQ,PQ,FAT,SAT
Vision Inspection
CCD Camera, Keyence, Congex, Dalsa
Container
Plastic BFS Container
Capacity
80-100 /Min
Printer
TTO, UV Laser, Coder
Optional
Inspection & Rejection

DESCRIPTION

The GMP/FDA BFS Labeling Machine with CCD Camera Inspection is an advanced automated labeling system designed for pharmaceutical Blow-Fill-Seal (BFS) containers, sterile packaging, and medical applications. Built with GMP-compliant design and FDA-compliant materials, the machine integrates high-precision labeling, CCD vision inspection, barcode verification, and complete production data recording. The system ensures accurate label application, real-time quality monitoring, and full product traceability to support regulated manufacturing environments and data integrity requirements.

GMP/FDA Compliant Pharmaceutical Design

  • Designed for regulated pharmaceutical and biotech production environments
  • Stainless steel construction with hygienic and easy-to-clean design
  • Uses FDA-compliant materials for product contact components

Advanced CCD Vision Inspection

  • Automatic inspection of label position, presence, barcode, and printed information
  • Real-time defect detection and automatic rejection of non-conforming products
  • High-resolution image capture for quality verification and investigation

Complete Data Integrity & Traceability

  • Records production parameters and inspection results automatically
  • Supports batch tracking and quality documentation management
  • Provides historical inspection images and audit-ready records

High Efficiency & Flexible Integration

  • Compatible with BFS filling and packaging lines
  • Easy recipe management and fast product changeover
  • Suitable for pharmaceutical, biotech, and IVD applications

 

 

SPECIFICATION

Item Specification
Application BFS containers, sterile pharmaceutical packaging, medical products
Labeling Type Automatic wrap-around / top / side labeling (customizable)
Inspection System High-resolution CCD camera vision inspection
Inspection Functions Label presence, position, barcode, OCR/OCV, printing quality verification
Labeling Accuracy ±0.5 mm (depending on container and label material)
Production Speed Up to 100-200 pcs/min (customizable according to requirements)
Container Compatibility BFS ampoules, plastic containers, customized BFS formats
Data Management Inspection data recording, image storage, batch traceability
Control System Industrial PLC + HMI touchscreen
Material GMP stainless steel construction
Compliance GMP design, FDA-compliant contact materials, supports 21 CFR Part 11 data integrity requirements

FAQ


Q1: Is this BFS labeling machine designed for GMP and FDA-regulated production?

Answer:
Yes. The machine is designed according to GMP requirements and uses FDA-compliant materials, making it suitable for pharmaceutical, biotech, and sterile BFS packaging applications.


Q2: What products can be labeled by this BFS labeling machine?

Answer:
The machine is designed for BFS containers, sterile plastic ampoules, pharmaceutical packaging, and medical products requiring high-accuracy labeling and inspection.


Q3: How does the CCD camera inspection system work?

Answer:
The CCD vision system captures real-time images of each labeled product and automatically checks label position, barcode readability, printing quality, and other critical quality attributes.


Q4: Does the machine record inspection data and images?

Answer:
Yes. The system can record inspection results, production parameters, and product images to support complete traceability, quality analysis, and data integrity management.


Q5: Can this BFS labeling machine be integrated into an automated pharmaceutical production line?

Answer:
Yes. The machine can be integrated with BFS filling, inspection, and packaging systems to create a complete automated production solution for regulated pharmaceutical manufacturing.

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