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OPERATION OF LAMINAR AIR FLOW

  • OBJECTIVE:
  • To lay down a procedure for operation of laminar airflow.
  • SCOPE:
  • This SOP is applicable to the procedure for operation of laminar airflow at {Company Name} {Location}.
  • RESPONSIBILITY:
  • Officer/Executive/Designee (QC) Micro. – Shall be responsible to follow the procedure as per SOP.
  • Head/Designee Quality Control – Shall be responsible for ensuring compliance as per SOP.
  • ACCOUNTABILITY:
  •  QA Head shall be Accountable for implementation of SOP.
  • PROCEDURE:
  • Laminar air flow: Laminar air flow (LAF) is a type of air flow that is smooth, uniform, and in a single direction. It’s achieved by drawing air through a HEPA filter, which removes particles as small as 0.3 microns, and then blowing it evenly across a workspace. This creates a clean and controlled environment that is ideal for work that requires minimal contamination.
Laminar Air Flow
  • Check the level of instrument base. The base should possess a uniform level with no up and downs.
  • Ensure that the laminar airflow station is free from dust and placed in such a position that no turbulence is created while opening the door.
  • Switch ON the mains.There are six switches at the left side or front side panel of the equipment and a magnehelic gauge at the centre or right side corner.
  • Switch (1&2) for air Flow – LAF – ‘ON’ & ‘OFF’Switch (3&4) for light – ‘LUX’ – ‘ON’ & ‘OFF’Switch (5&6) for UV light – ‘UV’ – ‘ON’ & ‘OFF’
  • The Air Flow and UV should be kept ON for about 30 minutes before carrying out any work under laminar airflow.

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  • Switch ‘OFF’ the UV and put ‘ON’ the normal light.
  • Check the magnehelic gauge reading and ensure that it is at zero before the LAF unit is switched ON.
  • Ensure that the magnehelic gauge reading is in between 10 -25 mm.
  • Maintain a record of the manometer readings daily as per Format-I.
  • Switch ‘OFF’ the LAF after the completion of the test.
  • Maintain a separate record for UV lamp burning hours (usually 2000hrs) as per Format-II.
  • ANNEXURES: 
Annexure No.Title of annexure
Annexure-IManometer /Maghnaulic gauge Readings Record
Annexure-IILAF UV Lamp Maintenance Record.
  • DISTRIBUTION:

Master Copy                    :          Quality Assurance Department

Controlled Copy No. 01  :          Head Quality Assurance

Controlled Copy No. 02  :         Head QC (Micro.)

  • ABBREVIATIONS:
No.:Number
SOP:Standard Operating Procedure
QC:Quality Control

REVISION HISTORY:            

CHANGE HISTORY LOG
Revision No.Details of ChangesReason for ChangeEffective Date
00New SOPNot ApplicableTo Be Written Manual

Annexure-I
Manometer/ Magnehelic Gauge Record Sheet

Manometer/ Magnehelic Gauge Record Sheet

Annexure-II
LAF – UV LAMP Maintenance Record

LAF - UV LAMP Maintenance Record

Click the link for download word file copy of this document:
https://pharmaguidehub.com/product/operation-of-laminar-air-flow/

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