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OPERATION OF DYNAMIC PASS BOX

  • OBJECTIVE:
  • To lay down the procedure for operation of Dynamic Pass Box.
  • SCOPE:

This SOP is applicable to procedure for Operation of Dynamic Pass Box at {Company Name} {Location}.

  • RESPONSIBILITY:
  • Officer/Executive/Designee Quality Control – Shall be responsible for operation as per SOP.
  • Head/Designee Quality Control – Shall be responsible for ensuring compliance as per SOP.
  • ACCOUNTABILITY:

             QA Head shall be Accountable for implementation of SOP.

  • PROCEDURE:
    • Switch ON the mains.
    • Switch ON the Fan.
    • Both the doors are provided with EM locks.
    • Check the door interlocking system.
    • It has two doors. Door 1 & Door 2.
    • When door 1 is opened the display on door 2 will indicate “No Go” and at the Door 1 display will indicate “Door Open”.
    • When any of the Door is kept open beyond 5 minutes, buzzer will be blown and the display will indicate “Close Door”.
    • When any one of the door is opened CF lamp will glows and UV lamp will switch OFF.
    • When the Doors are closed UV lamp will glow and CF lamp will switch OFF.
    • Fan will be ON whether door is open / close.
    • Switch OFF the fan when there is no activity.
    • Switch OFF the main
  • Fact of Dynamic Pass Box:
  • A dynamic pass box is an enclosed anteroom used to transfer materials between two controlled environments, typically of different classifications, while minimizing the risk of contamination between the two areas. It is commonly used in quality control (QC) laboratories to transfer materials between, for example:
  • A cleanroom and a non-cleanroom area
  • Two cleanrooms with different classifications (e.g., ISO 7 and ISO 5)
  • A quarantine area and a non-quarantine area
  • How it works:
  • A dynamic pass box has two interlocked doors, one on each side. When one door is open, the other door is automatically locked, preventing direct contact between the two environments. The pass box is equipped with a HEPA filter and a blower system that creates a positive pressure environment inside the box. This positive pressure helps to prevent contaminants from entering the cleaner environment from the less clean environment.
  • Benefits of using a dynamic pass box in QC:
  • Reduces the risk of contamination: By minimizing the transfer of airborne contaminants between different environments, dynamic pass boxes help to protect the integrity of your products and processes.
  • Improves efficiency: Dynamic pass boxes can help to improve workflow by providing a quick and easy way to transfer materials between different areas.
  • Protects personnel: Dynamic pass boxes can help to protect personnel from exposure to potentially hazardous materials.
  • REFERENCES:

Not Applicable

  • ANNEXURES: 

Not Applicable

         ENCLOSURES: SOP Training Record.

  •  DISTRIBUTION:
  • Controlled Copy No. 01  :          Head Quality Assurance
  • Controlled Copy No. 02  :         Head Quality Control
  • Master Copy                    :          Quality Assurance Department
  • ABBREVIATIONS:
No.:Number
SOP:Standard Operating Procedure
EM:Electro Magnetic.
UV:Ultraviolet.
CF:Compact Fluorescent
QC:Quality Control
  • REVISION HISTORY:             

CHANGE HISTORY LOG

               Revision No.Details of ChangesReason for ChangeEffective Date
00New SOPNot ApplicableTo Be Written Manual
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