To lay down a procedure for Operation, Cleaning and Calibration of laminar airflow chamber
1.0 PURPOSE
1.1 To lay down a procedure for Operation, Cleaning and Calibration of laminar airflow chamber (ALPHA LINEAR) Equipment identification No: XXXXX
2.0 SCOPE
2.1 This Sop covers the Operation, Cleaning and Calibration procedure of Laminar air flow
3.0 RESPONSIBILITY
3.1 Microbiologist
4.0 ACCOUNTABILITY
4.1 Deputy Manager - Quality Control
5.0 PROCEDURE
5.1 Operation
5.1.1 Connect the power plug to the socket
5.1.2 Check the manometer reading initially that oil level at zero
5.1.3 Enter the details of it LAF UV Lamp and Manometer Record as per annexure-1.
5.1.4 Put on the power switch to start up.
5.1.5 Manometer reading should not be less than 10mm water gauge scale while laminar airflow is running
5.1.6 There are three switches and a pressure manometer at the left side panel of the instrument.
5.1.6.1 Switch (1) for air flow
5.1.6.2 Switch (2) for tube light
5.1.6.3 Switch (3) UV light
5.1.7 Put ON the switch (1) to start the airflow.
5.1.8 Put ON switch (2) to start normal light.
5.1.9 All the three indicator switches glow red when switched ON.
5.1.10 Put ON the airflow and UV lamp for about 15 minutes before carrying out any work under laminar airflow.
5.1.11 Switch OFF the UV lamp put ON the normal light while performing the test.
5.1.12 While testing use burner flame to carry out microbial analysis.
5.1.13 Switch OFF the airflow followed by normal lamp and put ON the UV lamp after the completion of test.
5.1.14 UV lamp consuming time shall be entered in to the LAF UV Lamp and Manometer record as per annexure-1.
5.1.15 Enter the working hours of LAF in LAF log book as per annexure -II
5.2 Cleaning
5.2.1 Clean the laminar airflow before and after completion of work.
5.2.2 The working bench, airflow grill, inside top portion and side glasses shall be cleaned by wiping with 70% Isopropyl alcohol.
5.2.3 After cleaning switch ON the UV lamp (Switch 3) when laminar flow is not in operation.
5.2.4 Prepare the Cleaning solution as per current version of Sop No: XXXXX
5.2.5 After cleaning of the Laminar airflow enter the details in LAF cleaning record as per Annexure–III.
5.3 Calibration
5.3.1 Air velocity test (A)
5.3.1.1 Air velocity test should be carried out by using Anemometer as per current version of Sop No-----
5.3.1.2 Carry out the velocity test in Laminar air flow at different locations as shown in appendix –I
5.3.1.3 Record the results in Calibration record in part as per annexure –IV
5.3.1.4 Frequency, Once in Six months or any maintenance activity is done
5.3.1.5 Acceptance criteria, average air velocity should be 90 ? 20 FPM
5.3.2 Air monitoring by Plate Exposing.
5.3.2.1 Carry out the air monitoring by plate exposure method as per current version of Sop No XXXXX.and by using locations shown in appendix -I
5.3.2.2 Record the results in Calibration record in part as per annexure –IV
5.3.2.3 Frequency, Once in Six months or any maintenance activity is done
5.3.2.4 Acceptance criteria, Total microbial count at each location should be <1 Cfu / plate
5.3.3 HEPA Filter Efficiency test
5.3.3.1 Carry out the HEPA filter efficiency by DOP test
5.3.3.2 The DOP test is carried out as per Current version of Sop No-------- by Out side party
5.3.3.3 Record the results in Calibration record in part as per annexure –IV
5.3.3.4 Frequency, Once in a year or any maintenance activity is done
5.3.3.5 Acceptance criteria, the Efficiency of the filter should not be less than 99.97%
END OF DOCUMENT
Microbiology, operation, cleaning, laminar air flow
