1.0 PURPOSE
1.1 To lay down a procedure for Operation, Cleaning and Calibration of Vertical Flow Ceiling Suspended Laminar. Equipment identification No: XXXXX
2.0 SCOPE
2.1 This Sop covers the Operation, Cleaning and Calibration procedure of Vertical Flow Ceiling Suspended Laminar
3.0 RESPONSIBILITY
3.1 Microbiologist
4.0 ACCOUNTABILITY
4.1 Head - 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 Two switches are present at right below of the instrument.
5.1.5.1 Switch (1 - Red) for air flow
5.1.5.2 Switch (2 - Green) for tube light
5.1.6 Put ON the switch (1 -Red) to start the airflow and manometer will show the reading of Airflow.
5.1.7 Put ON switch (2 -Green) to start normal light.
5.1.8 Enter the working hours of the instrument in Vertical Flow Ceiling Suspended laminar logbook as per annexure -II
5.2 Cleaning
5.2.1 Clean the vertical Flow Ceiling Suspended laminar, airflow grill, top portion and sidewalls by wiping with 70% Isopropyl alcohol.
5.2.2 Prepare the Cleaning solution as per current version of Sop No: XXXXX
5.2.3 After cleaning of the vertical Flow Ceiling Suspended laminar enter the details in vertical Flow Ceiling Suspended laminar 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 Vertical Flow Ceiling Suspended Laminar 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 if any maintenance activity is done
5.3.1.5 Acceptance criteria, average air velocity should be 90 - 110 FPM
5.3.2 Air monitoring by Plate Exposing. (B)
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 B 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 (C)
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 C 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 (D)
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 D 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, suspended, vertical, suspended laminar