SOP For Operation and Cleaning of Laminar Air Flow (LAF) Workstation

SOP For Operation and Cleaning of Laminar Air Flow (LAF) Workstation

1.0 Objective

1.1 To establish a procedure for the operation and cleaning of Laminar Air Flow (LAF) workstations to ensure a controlled, particle-free working environment.

2.0 Scope

2.1 This SOP is applicable to the operation and cleaning of Laminar Air Flow (LAF) workstations in the Production Department.

3.0 Responsibility

3.1 Operator – Production

• Responsible for performing cleaning and operation of the LAF workstation as per this SOP.

3.2 Officer or Above – Production

• Responsible for preparation of SOP and monitoring of 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 adherence to this SOP.

3.5 Head – Quality Assurance (QA)

• Responsible for approval of this SOP.

4.0 Accountability

4.1 Head – Production

• Accountable for overall implementation of this SOP.

5.0 Definition & Abbreviations

5.1 Definitions

5.1.1 Standard Operating Procedure (SOP)
A written authorized document that provides step-by-step instructions for performing routine activities in a consistent and controlled manner.

5.1.2 Laminar Air Flow (LAF)
A system designed to provide a particle-free working environment by passing air through filtration systems and delivering it in a uniform laminar airflow across the work surface.

5.2 Abbreviations

6.0 Precautions, Safety & EHS

6.1 Ensure the LAF unit is started at least 30 minutes prior to commencement of operations.

6.2 Ensure proper handling of electrical systems; switch OFF the Main MCB before cleaning.

6.3 Use only filtered 70% v/v Isopropyl Alcohol (IPA) for cleaning and sanitization.

7.0 Materials & Equipment

7.1 Materials

• 70% v/v IPA solution (filtered)

• Sterile mop

• Water for Injection (WFI)

7.2 Equipment

• Laminar Air Flow (LAF) Workstation

8.0 Procedure

8.1 Cleaning of LAF Workstation

8.1.1 Switch OFF the Main MCB of the LAF unit.

8.1.2 Clean the internal surface of the LAF cabinet using a lint-free cloth soaked with WFI to remove dust and particles.

8.1.3 Wipe the surfaces thoroughly using 70% v/v IPA solution to ensure proper disinfection.

8.2 Operation of LAF Workstation

8.2.1 Switch ON the Main MCB of the LAF unit.

8.2.2 Start the blower and light of the LAF workstation.

8.2.3 Allow the LAF unit to run for at least 30 minutes before use.

8.2.4 Check and ensure that the pressure differential is maintained between 10 mm to 15 mm.

8.2.5 Ensure proper airflow conditions before initiating any production activity.

9.0 Annexures