Brief Description
This SOP describes the procedure for the operation, cleaning, and routine use of a pass box in the Quality Control/Microbiology and dispensing areas. Its objective is to ensure that sterilized materials and necessary tools are transferred through the pass box in a controlled manner. The SOP assigns responsibility for execution to microbiologists and store personnel, while the Store In-charge, Manager-QC, and Head QA/QC are responsible for effective implementation. Before use, the pass box is cleaned with 70% IPA solution, followed by switching on the main electrical supply. Sterilized materials and tools are placed inside, and the door is closed. The SOP specifies that the UV light remains ON when the pass box is closed and switches OFF automatically when opened. Materials are then transferred to the LAF/RLAF for further work. After completion, remaining materials are removed, the pass box is again cleaned with 70% IPA, and the electrical supply is switched off when no longer required.The SOP also includes training requirements, document distribution, abbreviations, revision history, and an Annexure-I Pass Box Cleaning Log Book for recording cleaning activities before and after work.
Skip to PDF content1. Flow Diagram:
The flow diagram presents the Operation of Pass Box in a simple comic-style training format where friendly devil characters guide personnel through each step. The process begins with cleaning the pass box using 70% IPA, followed by switching ON the main electrical supply. Sterilized materials and required tools are then placed inside the pass box and the door is closed. The diagram highlights that the UV light remains ON when the pass box is closed and turns OFF automatically when the door is opened.
The materials are subsequently transferred from the microbiology laboratory or dispensing area through the pass box to the LAF/RLAF for further work. After completion of the activity, all remaining materials are removed, and the pass box is cleaned again with 70% IPA solution. Finally, when the pass box is no longer required, the main electrical switch is turned OFF. The comic presentation makes the SOP easy to understand and suitable for GMP training.
2. Brainstorming for SOP Failure:
The brainstorming diagram identifies possible causes that may lead to SOP failure during pass box operation. The comic-style presentation uses muscular devil characters as trainers to make the discussion engaging and easy to understand. Major failure possibilities include not cleaning the pass box with 70% IPA before use, failure to switch ON the main electrical supply, placement of unsterilized or incorrect materials, improper door handling, misunderstanding or malfunction of the UV light, incorrect transfer of materials to the LAF/RLAF, failure to remove remaining materials after work, and not cleaning or switching OFF the pass box after use.
The diagram also highlights underlying causes such as lack of training, human error, poor supervision, and inadequate logbook recording. These points are consistent with the SOP steps requiring cleaning, correct operation, material transfer, post-use cleaning, and shutdown. The brainstorming approach helps the team discuss multiple possibilities, identify root causes, and develop corrective actions to prevent recurrence.