SOP for Operating, Cleaning and Maintenance Procedure of Pass Boxes

1.0 OBJECTIVE
To provide an operating, cleaning and maintenance procedure for Pass boxes in the VISION, PFS and LYO Units.

2.0 SCOPE
This SOP shall be applicable for Production Department.

3.0 ASSOCIATED DOCUMENTS
Not applicable.

4.0 RESPONSIBILITY/ACCOUNTABILITY
4.1 All Production personnel shall be responsible for implementation of the procedure.
4.2 Manager, Production or his Designee shall be accountable for training and implementation of the procedure.

5.0 ABBREVIATIONS AND DEFINITIONS
Not applicable.

6.0 PRECAUTIONS /SPECIAL INSTRUCTIONS
6.1 Do not try to open the door of pass box when red light is on.
6.2 After putting materials in the pass box close the door and switch-on the air shower for 2 minutes.
6.3 Do not try to open the door of pass box when air shower is continuing.
6.4 Try to avoid spillage of the materials passing through the passboxes.

7.0 PROCEDURE
7.1 Types of Pass Boxes with their location are as follows :
Types of pass boxes of VISION Location
Air shower Pass Box (VIS-MCE-PR-PK-10-PBX02) between Grade D & C
Air shower Pass Box (VIS-MCE-PR-MS-10-PBX05) between Grade C & B
Air shower Pass Box (VIS-MCE-PR-FL-10-PBX01) between Grade C & B
Pass Box (VIS-MCE-PR-PK-10-PBX03) between General Area and Grade D
Pass Box (VIS-MCE-PR-MS-10-PBX04) between General Area and Grade D
Types of pass boxes of PFS Location
Air shower Pass Box (PFS-MCE-PR-CC-11-PBX01) between Grade D (IO-15) & C (VP-10)
Air shower Pass Box (PFS-MCE-PR-CC-11-PBX02) between Grade B (IO-08) & C (VP-10)
Air shower Pass Box (PFS-MCE-PR-FL-11-PBX03) between Grade C (Corridor) & B (Stage)
Air shower Pass Box (PFS-MCE-PR-CC-11-PBX04) between Grade C (Corridor) & D (Filled Ampoule Stage)
Air shower Pass Box (PFS-MCE-PR-PK-11-PBX01) between Grade D (Packaging) & B (Filing
Air shower Pass Box (PFS-MCE-PR-FL-11-PBX01) between General Area (PPM Entry) &
Pass Box (PFS-MCE-PR-PK-11-PBX02) between General Area (Corridor VP-14)
Types of pass boxes of LYO Location
Air shower Pass Box (LYO-MCE-PR-ME-12-PBX02) between Grade C & D
Air shower Pass Box (LYO-MCE-PR-ME-12-PBX03) between Grade D & C
Air shower Pass Box (LYO-MCE-PR-ME-12-PBX04) between Grade B & D
Pass Box (LYO-MCE-PR-ME-12-PBX01) between General Area and Grade D
Pass Box (LYO-MCE-PR-ME-12-PBX05) between General Area and Grade D
Pass Box (LYO-MCE-PR-ME-12-PBX06) between General Area and Grade D

7.2 OPERATING STEPS (Electric Pass Box)
7.2.1 Ensure both entry and exit doors are closed by observing the green indicator lamp ON.
7.2.2 Open the entry door by handle and put or remove material from pass box and close the door immediately.
7.2.3 When one door is open the other door side’s red indicator lamp shall be ON and in this condition other side door will not be opened.
7.2.4 After closing the door switch on the air shower for 2 minutes and then switch it off. After each opening and closing of the door the air shower must be activated for 2 minutes.
7.2.5 After closing the door both sides green indicator lamps shall be ON.

7.3 OPERATING STEPS (Mechanical Pass Box)
7.3.1. Ensure entry and exit side doors are closed.
7.3.2. Open any door by pulling handle.
7.3.3. When one door is open the other door will not be opened.
7.3.4. Put or remove materials from the pass box.
7.3.5. Close the door opened.

7.4 CLEANING
Pass Boxes shall be cleaned and sanitized by wiping with 70% IPA solution.

7.5 MAINTENANCE
7.5.1 Breakdown Maintenance
If the equipment is malfunctioning, inform Engineering Department. Engineering Department shall assess the problem and decide repairing or replacement of equipment. In case of repairing Engineering Department shall fix the problem and assess to perform requalification (in case of electric pass box) of the equipment.
If the equipment is found not repairable then consideration is given to scrapping the same with affixing a tag marked “REJECTED”. The equipment shall be replaced with a new one.

7.5.2 General Maintenance
The air velocity (in case of electric pass box) shall be measured annually.

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