Product Overview

Zowinda's Medical Patch Cartoner delivers end-to-end automated packaging for adhesive medical products with 75 boxes per minute output. Designed for pharmaceutical and wound care manufacturers, this system provides:

✔ Tool-Free Adjustments – Quick change between product sizes
✔ Intelligent Quality Control – Vision inspection rejects empty boxes
✔ Flexible Sealing Options – Hot-melt glue or mechanical brush sealing
✔ Low-Noise Operation – ≤75 dB for worker comfort

Ideal for:

• Band-Aid/bandage producers

• Transdermal patch manufacturers

• First-aid product suppliers

Technology Highlights

1. Smart Packaging Process

1. Automatic Feeding – Patches oriented correctly

2. Precision Carton Forming – Servo-controlled unfolding

3. Insertion & Verification – Photoelectric detection ensures:
   → Correct patch placement
   → No empty boxes advanced

4. Sealing & Coding – Optional hot-melt glue or labels
   
   

2. Advanced Control System

• PLC + Touchscreen HMI

  • Stores 50+ product recipes

  • Real-time production analytics

• Integrated Safety
  → Overload protection
  → Misfeed auto-shutdown
  
  

3. Line Integration Ready

• Synchronizes with:
  → Blister packers
  → Labelers
  → Inkjet printers
  → Checkweighers

• IoT-enabled for Industry 4.0 connectivity

Technical Specifications

Certified Performance

◈ FDA 21 CFR Part 11 compliant data logging
◈ CE Marked electrical systems
◈ ISO 14644 cleanroom compatible (optional)

Why Choose Zowinda?

✅ 300+ installations in 18 countries
✅ 18-month performance guarantee
✅ 24/7 remote diagnostics

Competitive Advantage Comparison

Key Differentiators:

1. Only cartoner with ≤75dB operation (OSHA-compliant)

2. Fastest changeover - 83% quicker than alternatives

3. Pre-validated protocols for FDA/EU submissions

Regulatory Success Cases

1. US Pharma Giant Implementation

• Client: Top 5 Transdermal Patch Manufacturer

• Challenge: FDA audit readiness for new production line

• Solution:
  → Pre-validated IQ/OQ documentation package
  → 21 CFR Part 11 data trails

• Result:
  ▸ Zero 483 observations in 2023 inspection
  ▸ 30% faster validation vs. previous system

2. EU Medical Startup Project

• Client: Innovative Cooling Patch Producer

• Challenge: MDR compliance for Class IIb device

• Solution:
  → Integrated UDI printing module
  → Technical File support

• Result:
  ▸ CE Mark achieved in 11 weeks (industry avg: 20+)
  ▸ 100% packaging traceability

Technical Specifications Update

New Available Options:

• Aseptic Barrier System (+$28,000) - For sterile products

• Robotic Loader (+$35,000) - For fully unmanned operation

• Blockchain Tracking (+$15,000) - Serialization beyond FDA DSCSA

Global Compliance Status

Why This Matters for Buyers:

1. Risk Reduction - Pre-validated for regulated markets

2. Future-Proofing - IoT/Blockchain ready

3. Labor Savings - 1 operator can manage 3 machines

Regional Packaging Compliance Solutions

1. North American Market

• FDA 21 CFR Part 211 Ready

  • Pre-validated protocols for:
    → Child-resistant packaging (CRP) for medicated patches
    → DSCSA serialization templates

• Health Canada Adaptation Kit

  • Bilingual (EN/FR) labeling integration

  • Cannabis packaging preset modes

2. European Union

• MDR Article 17 Compliance Package

  • UDI carrier integration (AIDC & HRI)

  • Annex I checklist automation

• Sustainable Packaging Mode

  • Recyclable material presets

  • Reduced glue consumption algorithm

3. Asia-Pacific

• China NMPA Special Configuration

  • Mandarin HMI with GB/T standards

  • Traditional medicine patch presets

• Japan PMDA Optimization

  • Smaller carton sizes (50×30mm min)

  • JIS-compliant safety guards

Implementation Example:

Client: Korean Herbal Patch Manufacturer
Challenge:

• Meet MFDS guidelines for traditional medicine

• Package 12 unique SKUs in <8hr changeover
  
  

• 

Zowinda Solution:

1. Installed PMDA/MFDS Dual-Compliance model

2. Added Korean-language HMI with:

   • Traditional medicine pictogram library

   • Ginseng patch-specific settings

3. Conducted local inspector training
   
   

Results:
▸ Passed MFDS inspection with zero non-conformities
▸ 92% OEE in first 3 months
▸ Featured in Korean Medical Device Journal

Why This Enhancement Matters:

1. Market-Specific Trust - Directly addresses regional pain points

2. Pre-Purchase Confidence - Tangible compliance resources

3. Post-Sale Support - Localized expertise on demand