This generic and flexible module is used to link different areas of other modules while keeping the cleanliness of a Class D GMP. This is the standard followed by ALL clean room modules of SAMPU.

Module’s general characteristics:

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 (see details below):

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

     
     

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

Structural concept

• Each SAMPU module is the combination of two levels, simplifying shipment and assembly:

  • Lower structure acting as a clean room level.

  • Upper structure acting as a technical level.

•  Module structure:

  • Metallic.

  • Resistant.

  • Transported as two separate packages (clean room level + technical level).

Clean room level

• General design criteria:

  • All materials and surfaces are designed following class D GMP standards:

    • Easy to clean, resistant to cleaning agents.

    • Non-porous surfaces to prevent dust accumulation.

      
      

• Panels:

  • Covering all the walls and ceilings, sandwich panels are used to guarantee clean rooms standard on cleanability and insulation.

  • Thickness 60mm.

  • External layer made of white lacquered galvanized steel.

  • Internal core made of PIR foam.

  • “Reaction to fire” class B-s1,d0 as per EN 13501-1.

    
    

• Doors:

  • Made in the same colour and materials as the panels.

  • Integrated window for operator comfort.

    
    

• Windows:

  • Depending on the modules layout, one or more windows may be included on the walls.

  • Thickness 60mm with double laminated crystal + air chamber.

  • Prepared to resist temperature and humidity (guaranteed against condensation).

    
    

• Profiling:

  • All edges and corners inside the rooms are covered with sanitary profiles.

  • They allow for easy cleaning and prevent dust accumulation.

  • Made of PVC and/or lacquered sheet.

    
    

• Silicone finishing:

  • Silicone finishing applied on all joints.

  • Sanitary silicon resistant to cleaning agents.

    
    

• Flooring:

  • The floor is covered with a PVC layer specifically designed for that feature.

  • Easy to clean and comfortable for the personnel.

  • Prevents water filtration.

    
    

• Lighting:

  • Square lights specifically conceived for clean room environments installed on ceiling.

  • 500 lux guaranteed on all working surfaces.

    
    

• HVAC diffusers:

  • The HVAC air is blown inside the rooms through rotational diffusers.

  • Made of lacquered steel.

  • Strategically placed to ensure homogeneous air renovation everywhere inside the room.

    
    

• HVAC returns:

  • Return grids placed on corners of the room.

  • Made of lacquered steel.

  • Strategically placed to ensure that the air flow removes the suspended particles on the room.

Technical level

Installed above the clean room level. It serves as an accessible technical space:

• HVAC ducts:

  • The treated air coming from HVAC module (see details here) is distributed and returned there through ducts:

    • Line of air impulsion.

    • Line of air return.

  • Made of galvanized steel. Flexible ducts NOT used for better resistance.

  • Insulation 15mm of elastomeric foam + foil finishing.

  • Manual dampers on all duct lines.

  • Registers to allow easy cleaning inside.

    
    

• Pipes for liquid and gases:

  • Liquid and gas utilities are pumped from:

    • Clean utilities module (see details here).

    • Black utilities module (see details here).

  • In the technical level of each module, the distribution pipes are installed.

    
    

• Cables:

  • Cables are passed through the technical level, installed on cable trays equipped with earthing.

  • Power and signal cables correctly separated.

  • Prepared connectors between modules allow for quick and reliable disassembly and reassembly of modules.

    
    

• Walkable passage connecting all technical levels.

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.