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SOP on Cleaning and Operation of Dynamic Pass Boxes

1.0 Scop: To Laydown procedure on Cleaning And Operation Of Dynamic Pass Boxes

2.0 Applicable to This SOP is applicable for cleaning and operation dynamic pass boxes (GMP Make) located in various Production, QC, and warehouse rooms.

3.0 Responsibility:

3.1 Asst. Manager/ Sr. Officer / Officer/Line coordinator shall execute this SOP.

3.2 Manager / Sr. Manager Shall supervise that the process is being followed as per SOP.

3.3 Head-Quality Assurance for ensuring the compliance of this SOP.

4.0 Safety considerations:

4.1 Do not try to open both side doors of the dynamic pass box forcibly at the same time.

4.2 Pressure on the Magnehelic gauge must be within the limit (10 to 15 mm of water).

4.3 70 % IPA shall be used within the specified use period on the label.

5.0 The Equipment:

5.1 (For Material entry from the warehouse)

5.2 (For the Material transfer to the warehouse)

6.0 Materials and reagents:

6.1 Filtered 70% IPA

7.0 Preparation of solutions:

7.1 follow SOP for Isopropyl alcohol 70% Preparation

8.0 Procedure:

8.1 Cleaning procedure:

8.1.1 Before cleaning, switch off the HEPA (High-Efficiency Particulate Air) filter blower.

8.1.2 Clean the pass box with a dry lint-free mop from inside and outside.

8.1.3 Disinfect the pass box with filtered 70 % IPA.

8.1.4 Frequency: Pass box shall be cleaned daily and after use, if required.

8.2 Operation of the Dynamic Pass Box (GMP Technical Solution Make):

8.2.1.1 Check light on the panel which shows the presence of Power supply

8.2.1.2 Press the “HEPA Filter ON” button to switch ON the blower.

8.2.1.3 Check the differential pressure on the gauge. It shall be within 10-15 mm of water.

8.2.1.4 Press the Door Open button on the panel.

8.2.1.5 Open the door and keep the material to be transferred.

8.2.1.6 Close the Door.

8.2.1.7 Press the door open button on the other side of DPB.

8.2.1.7 Open the door, take out the material and close the door again.

8.2.1.8 In case of spillage, clean the inner and outer surface of the equipment with the help of a clean mop soaked with 70 % IPA.

9.0 Abbreviations:

QA: Quality Assurance

SOP: Standard Operating Procedure

IPA: Isopropyl alcohol

mm: millimeter

DPB: Dynamic Pass Box

% : Percent

PR: Production

Sr.: Senior

HEPA: High-Efficiency Particulate Air

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