SOP for Operation, Cleaning and Monitoring of Laminar Air Flow

1.0 PURPOSE

To lay down the procedure to perform the Operation of Laminar Air Flow.

2.0 SCOPE

It is applicable to Laminar Air Flow in the microbiology lab.

3.0 RESPONSIBILITY

Microbiologist

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Operation of Laminar Air Flow

5.1.1 Mop the bench with 70 % isopropyl alcohol/ disinfectant.
5.1.2 Switch on the main supply.
5.1.3 Ensure equipment is in a clean state.
5.1.4 Start blowers 30 minutes prior to the operation.
5.1.5 Record the differential pressure across the High efficiency Particulate Air (HEPA) filter.
5.1.6 Ensure the adequate protective gear is worn during the operation such as gloves, cap, and mask.

5.2 Cleaning of Laminar Air Flow

5.2.1 Keep the laminar airflow interior and exterior free from dust.
5.2.2 Before starting work, clean with 70% Isopropyl alcohol (IPA) / Disinfectant using a non-fiber shedding cloth.
5.2.3 Inside cleaning of the laminar air flow is recommended in the following cases.
5.2.3.1 Before starting any work in the laminar air flow.
5.2.3.2 After working in the cabinet.
5.2.3.3 Whenever there is the change of work program.
5.2.3.4 In the event of spillage on the worktable.

5.3 Shuting - down procedure

5.3.1 Disconnect all utilities.
5.3.2 Turn off the burner and close the gas tap.
5.3.3 Switch off the main motor.
5.3.4 Clean down the entire area with 70 % Isopropyl alcohol / Disinfectant
5.4 Record the Details like Differential pressure, Cleaning, Instrument switched On/Off.

5.5 Monitoring of Laminar Air Flow

Monitoring of laminar air flow can done by following ways,

5.5.1 Passive air sampling

5.5.1.1 Transfer the petriplate into pass box.
5.5.1.2 Decontaminate the external surface of the petriplates with the help of a sterile mop soaked in a filtered sporocidal agent.
5.5.1.3 Enter the respective area as per the SOP for microbiological testing area..
5.5.1.4 Place the petriplates on the bench of Laminar airflow and remove the upper lid of the petriplates and keep it in inverted position.
5.5.1.5 Mark the petriplates at the base with the following details with marker,
Media lot no
Name of the location
Date of exposure
Exposed by
5.5.1.6 Expose the media plate for 4 hours, After 4 hours of exposure, close the petriplate with lid. Collect the petriplate and transfer the plates into the incubator.
5.5.1.7 Incubate the exposed petriplate in inverted position in the incubator at 32.5 ± 2.5°C for 5 day.
5.5.1.8 After incubation observe and count the number of colonies on the colony counter or in the light source with the help of marker.
5.5.1.9 Note down the observation.
5.5.1.10 If the counts obtained are above the limits specified below investigate the results and take necessary actions as per SOP.
5.5.1.11 Frequency of Monitoring
Class A: Once in a day whenever there is activity.
5.5.1.12 Acceptance criteria
Action limit: Class A: 1 CFU / plate

5.5.2 Active air sampling

5.5.2.1 Transfer the required number of media cassette, plate, and accessories into pass box (LAL test room to Incubator).
5.5.2.2 Decontaminate the external surface of the petriplates with the help of a sterile mop soaked in a filtered sporocidal agent.
5.5.2.3 Enter the respective area as per the SOP.
5.5.2.4 Mark the petriplate at the base with the following details with marker,
Media lot no
Name of the location
Date of exposure
Exposed by
5.5.2.5 Place the media cassette on the Air sampler and operate the instrument as per SOP for air sampler.
5.5.2.6 After completion of sampling collect all the plates and incubate in inverted position in the incubator at day and 32.5 ± 2.5°C for 5 day.
5.5.2.7 After incubation observe and count the number of colonies on the colony counter or in the light source with the help of marker.
5.5.2.8 Note down the observation.
5.5.2.9 If the counts obtained are above the limits specified below investigate the results and take necessary actions as per SOP.
5.5.2.10 Frequency of Monitoring
Class A: Once in a day
5.5.2.11 Acceptance criteria
Action limit: Class A: 1 CFU / plate

5.5.3 Non viable particle count

5.5.3.1 Keep the non-viable particles counter in the pass box (LAL test room to Incubator).
5.5.3.2 Decontaminate the external surface of the petriplates with the help of a sterile mop soaked in a filtered sporocidal agent.
5.5.3.3 Enter the respective area as per the SOP.
5.5.3.4 Operate the sampler according to SOP.
5.5.3.5 Perform the non-viable particle count at two different locations after completion of the activities.
5.5.3.6 Record the details of non viable particles count.
5.5.3.7 Frequency: Once in fifteen days
5.5.3.8 Acceptance criteria

Alert Limit	Action Limit	Action Limit	Action Limit
0.5 m / ft3	0.5 m / ft3	5 m / ft3	5 m / ft3
50	100	Nil	Nil

6.0 ABBREVIATIONS

6.1 SOP - Standard operating procedure
6.2 % - Percent
6.3 HEPA - High efficiency Particulate Air filter
6.4 CFU - Colony forming unit
6.5 °C - Degree centigrade
6.6 µ - Micron
6.7 ft3 - Cubic feet

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