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SOP For Laminar Air Flow Workbench - Pharmaguideline
SOP For Laminar Air Flow Workbench - Pharmaguideline
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4.0 ACCOUNTABILITY
Manager - Quality Control
5.0 PROCEDURE
5.1 General cleaning
5.1.1 Clean the exposed surfaces of the Laminar air flow first with a clean dry cloth/ tissue paper followed by a wet mop of either 2.5 % dettol or 70 %
Isopropyl alcohol solution on the rotation basis.
5.2 Cleaning of filters
5.2.1 Laminar air flow has two filters i.e. Pre-filter and HEPA filter (High Efficiency Particulate Air Filter).
5.2.2 In case the magnehelic gauge indicates the filter choking, the Pre-filter shall be cleaned using a vacuum cleaner.
5.2.3 Pre-filter shall be checked once in three months for the accumulation of dust.
5.2.4 Pre-filters shall be washed with a mild detergent and dried, if excessively dirty.
5.2.5 HEPA filter shall not be touched or opened by the laboratory personnel.
5.2.6 An authorized service engineer who shall also check for any rupture of the HEPA filters shall service the LAF bench annually.
5.2.7 A proper record of cleaning and servicing shall be kept by microbiologist and preserved for a minimum of two years.
5.3 Operation
5.3.1 Clean the exposed surfaces of L.A.F first with a clean, dry cloth/ tissue paper. Then clean the exposed surfaces with a wet mop of either dettol
solution or 70% IPA.
5.3.2 Switch ON the main switch of L.A.F.
5.3.3 Turn the knobs of Airflow and U.V. lamp to ‘ON’ position and ensure that the pressure reading is between 7.0 to 15 mm.
5.3.4 Keep the U.V. lamp and Air Flow 'ON' for 30 min before the start of work.
5.3.5 After 30 min put 'OFF' the U.V. lamp and put 'ON' the normal light in the L.A.F and then start work.
5.3.6 After completion of work in LAF bench, again clean it with dettol solution or 70% IPA.
5.3.7 Turn the knobs of Airflow and light to 'OFF' position and put 'OFF' the main switch of LAF.
6.0 ABBREVIATIONS
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4/27/23, 4:04 PM SOP for Laminar Air Flow Workbench : Pharmaguideline
ANNEXURE – I
LAF USAGE LOG
Date Manometer Reading/ Magnelic UV light Start time Off Time Remarks Used by Checked by
Gauge mm usage hours
(7.0 to 15.0)
ANNEXURE – II
CALIBRATION RECORD OF LAMINAR FLOW BY PLATE EXPOSURE METHOD
Inst. ID No. : Ref. SOP No. :
Make : Model No. :
Date _____________
Medium Used :
Plate Exposed For : 30 Minutes
Plate Incubated At : 32.5 °C / 22.5 °C + 2.5 °C
Plates Incubated For : 48 Hrs. / 5 Days
Frequency : Once In 15 Days
Observations
Positive Control :
Negative Control :
Limits : No Growth Should Be Observed In Any Plate.
S No. Location Result after48 hrs at 30 - 350 Result after 72 hrs at 20 - 250 C (cfu) Organism Found
C (cfu)
REMARKS : The above mentioned laminar flow is working / not working satisfactorily and does not require / requires maintenance work.
Date: Done By: Checked By:
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical
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