To lay down a procedure for Operation, Cleaning and Calibration of Garment Cabinet.
1.0 PURPOSE
1.1 To lay down a procedure for Operation, Cleaning and Calibration of Garment Cabinet. Equipment identification No: XXXXX
2.0 SCOPE
2.1 This Sop covers the Operation, Cleaning and Calibration procedure of Garment 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 Two switches are present at right below of the instrument.
5.1.4.1 Switch (1 - Red) for air flow
5.1.4.2 Switch (2 - Orange) for UV light
5.1.4.3 Switch (3 - Green) for tube light
5.1.5 Put ON the switch (1 -Red) to start the airflow and manometer will show the reading of Airflow.
5.1.6 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
5.1.7 Put ON switch (3 -Green) to start normal light.
5.1.8 Put ON switch (2 -Orange) to start UV light.
5.1.9 Enter the working hours of the instrument in Garment Cabinet logbook as per annexure –I
5.1.10 Enter the UV Lamp Consumed hours in Annexure –I
5.2 Storage of Garments
5.2.1 After washing the Garments and booties bring them to the Microbiology lab Change Room –I where the Garment Chamber is located.
5.2.2 Open the Cabinet door when the Laminar airflow of the cabinet is in running condition.
5.2.3 Hang the garments and booties to the hangers and hang them to the Hanger rod inside the Garment cabinet and close the door.
5.2.4 Put On the 2- Orange Switch to turn ON the UV light.
5.2.5 Wait for half an hour and use the garments and booties for gowning.
5.3 Cleaning
5.3.1 Clean the Garment Cabinet, airflow grill, top portion, Visual Glass Door, Hanger Rod and sidewalls by wiping with 70% Isopropyl alcohol.
5.3.2 Prepare the Cleaning solution as per current version of Sop No: QC117
5.3.3 After cleaning of the Garment Cabinet enter the details in Garment Cabinet cleaning record as per Annexure–II.
5.4 Calibration
5.4.1 Air velocity test (A)
5.4.1.1 Air velocity test should be carried out by using Anemometer.
5.4.1.2 Carry out the velocity test in Garment Cabinet at different locations as shown in appendix –I
5.4.1.3 Record the results in Calibration record in part A as per annexure –III
5.4.1.4 Frequency, Once in Six months or any maintenance activity is done
5.4.1.5 Acceptance criteria, average air velocity should be 90 ? 20 FPM
5.4.2 Air monitoring by Plate Exposing.
5.4.2.1 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
5.4.2.2 Record the results in Calibration record in part B as per annexure –III
5.4.2.3 Frequency, Once in Six months or any maintenance activity is done
5.4.2.4 Acceptance criteria, Total microbial count should be <1 Cfu.
5.4.3 HEPA Filter Efficiency test
5.4.3.1 Carry out the HEPA filter efficiency by DOP test
5.4.3.2 The DOP test is carried out by Out side party
5.4.3.3 Record the results in Calibration record in part C as per annexure –III
5.4.3.4 Frequency, Once in a year or any maintenance activity is done
5.4.3.5 Acceptance criteria, the Efficiency of the filter should not be less than 99.97%
5.4.4 Particle Count Test
5.4.4.1 Carry out the Particle Count with Particle Counter DOP test
5.4.4.2 The Particle Count test is carried out by Out side party
5.4.4.3 Record the results in Calibration record in part D as per annexure –III
5.4.4.4 Frequency, Once in a year or any maintenance activity is done
END OF DOCUMENT
Operation, cleaning, calibration, garment cabinet, microbiology
