- 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.
- 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-I | Manometer /Maghnaulic gauge Readings Record |
Annexure-II | LAF 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 Changes | Reason for Change | Effective Date |
00 | New SOP | Not Applicable | To Be Written Manual |
Annexure-I
Manometer/ Magnehelic Gauge Record Sheet
Annexure-II
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/