To lay down a procedure for Operation, Cleaning and Calibration of Bio Safety Cabinet.
1.0 OBJECTIVE
1.1 To lay down a procedure for Operation, Cleaning and Calibration of Bio Safety Cabinet. Equipment identification No: XXXXX
2.0 SCOPE
2.1 This Sop covers the Operation, Cleaning and Calibration procedure of Bio Safety Cabinet
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 Put on the power switch to start up.
5.1.4 Manometer reading should not be less than 10mm water gauge scale while laminar airflow is running Enter the details of manometer reading in Annexure -I
5.1.5 There are four switches and a pressure manometer at the left side panel of the instrument.
5.1.5.1 Switch (1) for air flow
5.1.5.2 Switch (2) for tube light
5.1.5.3 Switch (3) for Exhaust
5.1.5.4 Switch (4) UV light
5.1.6 Put ON the switch (1) to start the airflow and manometer no –2 will show the reading of Airflow.
5.1.7 Put ON switch (2) to start normal light.
5.1.8 Put on the Switch (3) for Exhaust and the manometer No –1 will show the reading of the exhaust.
5.1.9 Put on the Switch (4) for UV Light.
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 An additional Electrical power point is present inside the cabinet for Cyclomixer / Loop sterilizer.
5.1.14 Switch OFF the airflow followed by normal lamp and put ON the UV lamp for about 15 minutes after the completion of test and cleaning as per below point No 5.2.1 –5.2.2.
5.1.15 UV lamp consuming hours shall be entered in to the LAF UV Lamp and Manometer record as per annexure-1.
5.1.16 Enter the working hours of laminar flow in BioSafety Cabinet logbook as per annexure -II
5.2 Cleaning
5.2.1 Clean the Bio Safety Cabinet before and after completion of work.
5.2.2 The working bench, airflow grill, inside top portion and sidewalls 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 Bio Safety Cabinet enter the details in Bio Safety Cabinet 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.
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 should be <1 Cfu.
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 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%
5.3.4 Particle Count Test
5.3.4.1 Carry out the Particle Count with Particle Counter.
5.3.4.2 The Particle Count test is carried out by Out side party.
5.3.4.3 Record the results in Calibration record in part as per annexure –IV
5.3.4.4 Frequency, Once in a year or any maintenance activity is done
END OF DOCUMENT
Operation, microbiology, calibration, cleaning
