SOP for LAF Unit in Sampling Room : Pharmaceutical Guidelines

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SOP for LAF Unit in Sampling Room

Standard operating procedure of Laminar air flow unit installed in sampling room.

1.0 OBJECTIVE

To lay down the procedure for operation and cleaning of LAF unit in Sampling Room at Raw Material Store.

2.0 SCOPE

This SOP shall be applicable for operation and cleaning of LAF unit in Sampling Room at Stores Department.

3.0 RESPONSIBILITY

Stores Assistant/QC Pharmacist

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Before starting the activity, store person shall ensure that the LAF unit is clean.
5.2 Check “CLEANED” status label.
5.2 Store person shall check and ensure for the ‘Zero’ reading in all three magnehelic gauges of LAF unit, when the LAF unit is switched off.
5.3 Switch on the Blower.
5.4 Switch on the Light.
5.5 Allow the LAF to run for at least 15 minutes before the start of observation & recording:

PRESSURE DROP ACROSS FINAL (HEPA) FILTER

Limit: 8 mm – 16 mm
Observe the reading and record the pressure of HEPA filter.
Incase reading is out of limit, Stop the operation & intimate Head-Store and Maintenance for rectification.

PRESSURE DROP ACROSS INTERMEDIATE FILTER

Limit: 3 mm – 6 mm
Observe the reading and record.
Incase reading is out of limit, clean /replace the intermediate filter.

PRESSURE DROP ACROSS PREFILTER FILTER

Limit: 1 mm – 6 mm
Observe the reading and record.
Incase reading is out of limit, clean /replace the pre filter.
5.6 Store person shall transfer the container one at a time from which the material is to be sampled under the LAF Unit.
5.7 After completion of sampling as per the standard sampling plan, well close the containers and then take out from the LAF unit.
5.8 Put “OFF” the LAF after completion of sampling and clean the LAF as per the SOP & record the cleaning activity.

6.0 ABBREVIATIONS

6.1 SOP – Standard operating procedure
6.2 HEPA – High efficiency particulate air
6.3 mm – Millimeter
6.4 LAF – Laminar air flow
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