SOP For Fogging of Sterile Area

SOP For Fogging of Sterile Area

1.0 Objective

1.1 To establish a procedure for fogging of sterile areas to maintain microbiological control and ensure a contamination-free environment.

2.0 Scope

2.1 This SOP is applicable to the fogging of sterile areas in the Production Department, including associated rooms and airlocks.

3.0 Responsibility

3.1 Operator – Production

• Responsible for performing fogging activities as per the defined procedure.

3.2 Officer or Above – Production

• Responsible for preparation of SOP and monitoring of fogging activities performed by the operator.

3.3 Executive or Above – Production

• Responsible for review of SOP and ensuring compliance.

3.4 Head – Production or Designee

• Responsible for implementation and compliance with this SOP.

3.5 Head – Quality Assurance (QA)

• Responsible for approval of this SOP.

4.0 Accountability

4.1 Head – Production and Head – QA

• Accountable for overall implementation and adherence to this SOP.

5.0 Definition & Abbreviations

5.1 Definitions

5.1.1 Standard Operating Procedure (SOP)
A written authorized procedure that provides step-by-step instructions to perform routine or repetitive activities, ensuring consistency and quality.

5.1.2 Sterile
Free from viable microorganisms capable of causing contamination or infection.

5.1.3 non-sterile
Not free from viable microorganisms.

6.0 Precautions, Safety & EHS

6.1 Personnel shall wear appropriate Personal Protective Equipment (PPE) such as mask, gloves, and goggles.

6.2 Do does not use flammable liquids for fogging and avoid exposure to open flames during operation.

6.3 Ensure that the fogger tank is clean before and after use.

7.0 Materials & Equipment

7.1 Materials

• Disinfectants as per the approved disinfectant schedule.

7.2 Equipment

7.2.1 ULV Fogger
7.2.2 Measuring Cylinder

8.0 Procedure

8.1 Fogging Procedure

8.1.1 Clean the area thoroughly using a lint-free duster prior to fogging.

8.1.2 Prepare the disinfectant solution as per the approved concentration and requirement.

8.1.3 Pour the prepared solution into the ULV fogger machine.

8.1.4 Connect the fogger to the power supply and switch it ON.

8.1.5 Adjust the flow control knob to regulate the discharge of the disinfectant.

8.1.6 Begin fogging and ensure uniform spraying throughout the selected area.

8.1.7 Perform fogging once in each shift in the following areas:

• Sterile area

• Material transfer room

• Airlocks

• Sterile corridor

• Filling room

• Double door autoclave unloading room

8.1.8 Display a warning tag “Area Under Fogging” at the entry points to restrict access.

8.2 Disinfectant Schedule for Fogging

Note: Follow the approved monthly disinfectant rotation schedule.

9.0 Annexures