This specific module includes two rooms:

• Washing room.

• Storage room.

  
  

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 8 as per ISO 14644 (Class D 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.

Washing Room

In the washing room, some of the key re-usable elements and tools are washed and dried:

• Moving parts of the filling machine.

• Tools of the sampling station.

• Tools of the reactors area.

• Equipped with:

  • Stainless steel 304 washing sink with two basins:

    • Purified Water (PW) Point of Use for manual washing.

    • Pharmaceutical Compressed Air (PCA) Point of Use, to dry the elements.

  • Stainless steel 304 furniture for temporary storage.

Storage Room

In the storage room, all the cleaned production materials and tools are stored, ready to be used:

• Changeover parts of the filling machine.

• Tools of the sampling station.

• Tools of the reactors area.

• Equipped with:

  • Stainless steel 304 furniture to store all the elements above.

Design and Manufacturing Criteria

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.