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Operation, Calibration, Cleaning and Maintenance of LAF

Operation, Calibration, Cleaning and Maintenance of LAF

  • Objective

To lay down the procedure for Operation, Calibration, Cleaning and Maintenance of LAF.

  • Scope

This SOP is applicable for Operation, Calibration, Cleaning and Maintenance of LAF in Microbiology Laboratory of (Pharmaceutical Company Name).

  • Responsibility
    • Microbiologist or above of Microbiology Laboratory: Preparation of SOP.
    • Head – Microbiology section / Nominee: Checking of the SOP.
  • Accountability
    • Head – Quality Control / Nominee: Compliance of SOP.
  • Abbreviations and Definitions

SOP                             : Standard operating procedure

No.                              : Number

QC                              : Quality Control

QA                              : Quality Assurance

LAF                            : Laminar Air Flow

  • Procedure

Make: Clean Room Presentations, Model No.: CRP HL(S) 5000 & 4000

  • Operation:  
    • Connect the LAF to the Mains Power supply and switch ON the mains.
    • The front panel of the LAF consists of the following buttons
    ON
    OFF

 

  • UNIDIRECTIONAL FLOW
    OFF
    ON

 

  • FLUORESCENT LIGHT
    ON
    OFF

 

  • GERMICIDAL LIGHT
    • Press ‘ON’ button of UNIDIRECTIONAL FLOW to turn ON the blower.
    • Press ‘ON’ button of FLUORESCENT LIGHT to turn ON the Light.
    • Press ‘ON’ button of GERMICIDAL LIGHT to turn ON the GERMICIDAL LIGHT.
    • Before starting the work, Switch on the Blower and GERMICIDAL LIGHT for 30 minutes. After 30 minutes switch off the GERMICIDAL LIGHT and Switch the FLOUORESCENT LIGHT on. Then slowly lift the front door up, to open.
    • Monitor the Positive pressure reading on Magnehelic gauge. It should be between 10 and 20 mm of water gauge.
    • Wipe the LAF Work bench with 70% IPA and then start the work as per requirement.
    • After completion of work, monitor the pressure reading on Magnehelic gauge.
    • Clean the work station with 70% isopropyl alcohol.
    • Close the door.
    • Press ‘OFF’ button of FLUORESCENT LIGHT to turn OFF the Light.
    • Press ‘OFF’ button of UNIDIRECTIONAL FLOW to turn OFF the Blower.
    • Press ON button of GERMICIDAL LIGHT to turn ON the GERMICIDAL LIGHT and keep it for 10 minutes.
    • Then Press OFF button of GERMICIDAL LIGHT to turn OFF the GERMICIDAL LIGHT.
    • Record the LAF usage details in the format given as Annexure No.
  • Calibration:
    • Perform the calibration of Magnehelic gauge once in a year by external party.
  • Cleaning and Maintenance:
    • Clean the inner walls, grill and workbench of LAF Cabinet before commencement   and after completion of each work with the help of lint free cloth wetted with disinfectant solution.
    • Clean the outer body of the LAF using a lint free cloth wetted with disinfectant solution twice (at the start and end of day’s work).
    • For Cleaning of the pre-filter remove the pre-filter from the LAF and then clean it as per SOP No.:
    • Pre-filter shall be cleaned by maintenance technician once in a month with compressed air and soap water.
    • Place the cleaned Pre-filter at its position. Switch on the LAF unit. Check the positive pressure on Magnehelic gauge. It should be between10 and 20 mm of water gauge.
    • If pressure reading on Magnehelic gauge is not achieved, put a status label `Under Maintenance’ & ask the Maintenance Department for necessary action.
    • If the reading is above 20 mm of water gauge, change the HEPA filter of the LAF.
  • Forms and Records (Annexures)
    • LAF Log Book

 

  • Distribution
    • Master copy    –       Quality Assurance
    • Controlled copies     – Quality Assurance, Production, Quality Control, Stores, Engineering and Human Resource
  • History:
Date Revision Number
Reason for Revision
00   NEW SOP

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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