This specific module is used as an entrance and exit for materials and personnel:

• PAL: Personnel Air Lock.

• MAL: Material Air Lock.

  
  

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

• 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.

    
    

• Technical level:

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

    
    

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

Air Lock system

The module is divided into two different areas:

1. Personnel airlock:

   • Used for entrance/exit of personnel.

     • The operator dresses with the special gowning for clean rooms.

   • Capacity for 2 people at the same time.

   • There is a bench in the middle to separate the areas with outside clothes and clean room clothes.

     • Bench made of inox 304.

   • There are closets to store all the gowning needed, and a trash can to throw the used gowning.

     • All of them conceived for clean room environment.

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2. Material airlock, divided in two sections:

   • Outside section for the warehouse operator to leave the materials.

   • Inside section for the clean rooms operator to pick up the materials and take them to production area.

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.

Design and Manufacturing criteria

In clean room environments, there must always be a “barrier” between the outside environment (dirty) and the inside environment (clean):

• On SAMPU systems, this barrier is the airlocks module. 

• This module is at a pressure higher than the outside. This way, when the door is opened, the airflow goes outside (no suspended particles will flow inside).

• This is supported by the “interlock”. That system prevents that two doors of a same airlock are opened simultaneously. This is an extra layer of security for the cleanliness inside:

  • Based on electro-magnetic locking device.

  • Includes an emergency button.

  • Includes a pilot to monitor status.

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.