This specific module includes the labelling machine prepared to:

• Label dimensions 180 x 100 mm (Length x height).

• Bottle size up to Ø70 mm and 180 mm height.

• Bottle volume from 10 ml to 250 ml.

• Production capacity:

  • 40 u/min (2.400 u/h).

  • Or 60 u/min (3.600 u/h).

    
    

Module’s general characteristics as per Base Clean Room Module: 

1. Clean room level:

   • Dimensions:

     • External: 5,84 m x 2’35 m x 2’6 m (Length x Width x Height).

     • Internal: 5,72 m x 2’23 m x 2’5 m (Length x Width x Height).

   • Classified ISO 9 as per ISO 14644 (Class CNC GMP).

   • Clean room panels and finishing as per SAMPU standards.

     
     

2. Technical level:

   • Technical area installed above including HVAC ducts, cables and piping.

     
     

3. Total combined height of clean room level + technical level is 4,5 m.

Labelling Machine stations

1. Label marking station:

   • Adjustable to label and bottle format.

   • Data that can be marked on the label:

     • Batch number (7 alphanumeric characters).

     • Manufacturing Date (MM/YYYY).

     • Expiration Date (MM/YYYY).

     • Including Datamatrix (5x5mm) or GTIN.

   • Verification after marking with a camera.

2. Label application station:

   • Horizontal label application.

   • Foam/silicone roller to assure that the label is correctly applied.

   • Manual change of the label roll in 2 minutes.

   • Labels autonomy of 30 minutes.

3. Label position verification:

   • Camera to verify:

     • That the label has been applied on the bottle.

     • Vertical centered of the label.

     • Inclination of the label.

4. Rejection station:

   • Rejection system without damaging the product.

   • Rejection station with robust & error-proof mechanism.

HMI

• Information retained with data integrity complying with CFR 21 Part 11.

• Prepared to generate:

  • Batch report.

  • Alarms report.

  • Audit trail report.

• Remote connection for aftersales services.

Design and Manufacturing criteria

• Operable by maximum 1 person.

• Bottles input and output height 950 ± 50 mm. Adjustable if required.

• All adjustable elements are reachable for the operator from only one equipment's side and adjustable with a numeric value.

• Poka-Yoke and fail-safe philosophies.

• According to regulations:

  • European Commission Vol. 4 EU Guidelines to Good Manufacturing Practice. Medicinal Products for Human and Veterinary Use. 

  • Good Manufacturing Practices of the Food and Drug Administration (FDA).

  • 21 CFR Part 11 “Electronic Records, Electronic Signatures”. Food and Drug Administration Title 21 of the Code of Federal Regulations. 

  • Equipment Directive 2006/42/EC.

  • EN ISO 14122: Safety of machinery - Permanent means of access to machinery, part 1 till 4. 

  • EN ISO 13849: Safety of machinery - Safety-related parts of control systems.

Documentation

• Design documentation.

• DQ protocol + report.

• As-built documentation:

  • CE Declaration of Conformity.

  • Layouts.

  • Electrical diagram.

  • Pneumatic diagram.

  • Datasheet of valves and/or instrumentation and components.

  • Calibration Certificates.

  • Operation manual:

    • Start-up procedure.

    • Format changeover procedure.

    • Cleaning procedure.

    • Alarms list with every troubleshooting.

  • Maintenance manual.

  • Spare parts list and fungible assets.

• FAT & SAT protocols + report.

• IQ & OQ protocols + report.

• PQ protocol + report.

  
  

The standard language of all documentation will be English.