The standard operating procedure for pass boxes in a cleanroom outlines the operational procedures and standards, enabling users to effectively utilize the pass box and maintain the cleanliness and safety of the cleanroom by preventing contamination.

Pass box serves as auxiliary equipment in cleanrooms, primarily facilitating the transfer of items between cleanrooms of varying cleanliness levels or between clean and non-clean areas. Its purpose is to minimize the frequency of door openings within the cleanroom environment and thereby mitigate pollution to the lowest possible level.

operation of pass box

Purpose

Utilize the pass box in a safe and efficient manner to ensure the sterilization efficacy of items.

Scope of application

This procedure applies to various types of pass boxes, including air shower pass boxes, laminar flow pass boxes, mechanical interlock pass boxes, and electronic interlock pass boxes.

Responsibility

The production workshop is accountable for adhering to this procedure and ensuring the pass box operates normally and is properly maintained.

The quality inspection department is tasked with conducting quality tests on the cleanroom pass box.

All maintenance activities carried out on the pass box must be documented and archived.

 pass box

Operation method

When transferring items using the pass box, start by wiping all external surfaces of the items with a disinfectant-soaked cloth (ensuring the cloth is not excessively dry). Then, open the outer door of the transfer window and disinfect the pass box by spraying disinfectant inside.

Place the items inside, close the door, and activate the ultraviolet light for disinfection. After disinfection, deactivate the ultraviolet light and allow individuals from the other side of the barrier environment to open the door, retrieve the items or medication, and close the door.

When transferring items from the clean area, begin by opening the inner door of the delivery window, placing the items to be delivered inside, and closing the door. Individuals outside the clean area can then open the outer door, retrieve the items, spray disinfectant into the delivery window, and close the door.

Watch the brief video demonstrating the item transfer process into the pass box:

Precautions

  • Clean the pass box with a disinfectant-soaked cloth once daily before use, and wipe it dry with a clean cloth after each use.

  • Explosive items are prohibited from being placed in the transfer window.

  • The doors on both sides of the pass window cannot be opened simultaneously.

  • Materials must undergo sterilization with ultraviolet light for at least 30 minutes inside the pass box.

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