This specific module includes the case packing and sealing machine prepared to:

• Case dimensions 595 mm x 395 mm x 395 mm (Length x Width x Height).

• Carton maximum dimensions 115 x 75 x 195 mm (Length x Width x Height).

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

• Production capacity:

  • 12 u/min (720 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.

Case Packing And Sealing Machine Stations

1. Case station:

   • Adjustable to case and carton format.

   • Manual feeding of the unfolded cases.

   • Automatic folded of the case.

2. Cartons/bottles station:

   • Adjustable to bottle/carton format.

   • Automatic feeding of bottles/cartons through a conveyor belt.

   • Automatic accumulation of the bottles/cartons to group them before placing them inside the folded case.

   • Pick&Place to put the grouped bottles/cartons inside the folded case.

3. Sealing station:

   • Automatic sealing from top and bottom of the packed case.

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.

• Vertical positioning of the bottles/cartons inside the case.

• 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.