SOP for Operation of Sampling Booth
1.0 Purpose
To define the procedure for the correct operation of the sampling booth to ensure clean, contamination-free, and safe conditions during the sampling of raw materials and to prevent cross-contamination.
2.0 Scope
This SOP is applicable for all personnel involved in the operation and maintenance of the sampling booth in the Quality Control (QC)/Warehouse of [Company Name].
3.0 Responsibility
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QC/QA Personnel: To operate the sampling booth as per this SOP and ensure compliance.
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Engineering: To maintain the booth and perform preventive maintenance and calibration.
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QA: To review and ensure adherence to GMP requirements.
4.0 Definitions
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Sampling Booth (Laminar Air Flow Booth / Dispensing Booth): A controlled environment designed to provide Class 100 air flow with HEPA filtration to maintain unidirectional flow, preventing contamination during sampling.
5.0 Materials and Equipment
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Sampling booth
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Approved cleaning/disinfectant solution
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Clean lint-free cloths/swabs
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Personal Protective Equipment (PPE)
6.0 Procedure
6.1 Pre-Operation Checks
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Ensure the booth area is clean and free from unnecessary materials.
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Verify that the differential pressure, temperature, and RH are within specified limits.
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Switch ON the main power supply of the sampling booth.
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Switch ON the blower and allow it to run for at least 15 minutes to stabilize airflow.
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Verify the HEPA filter integrity status as per the last qualification.
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Ensure the magnahelic gauge reading is within the specified range.
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Record equipment logbook entries before use.
6.2 Operation
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Wear appropriate PPE (gown, gloves, mask, shoe cover, etc.) before entering.
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Disinfect the booth work surface with approved disinfectant before starting.
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Bring only the required materials into the booth.
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Perform sampling activities inside the booth as per SOP on Sampling of Raw Materials.
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Ensure unidirectional airflow is not blocked during operation.
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Avoid unnecessary movement to minimize turbulence.
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Collect samples in clean, labeled containers/polythene bags.
6.3 Post Operation
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After sampling, remove all materials and transfer them to the designated area.
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Clean the work surface with approved disinfectant.
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Switch OFF the blower and lights after use.
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Record operation details in the Sampling Booth Logbook (date, time, operator name, activity).
7.0 Precautions
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Do not switch ON/OFF the booth frequently.
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Never use the booth for purposes other than designated sampling.
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Do not block air grills or filters.
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Ensure calibration and preventive maintenance are performed as scheduled.
8.0 Records
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Sampling Booth Logbook
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Preventive Maintenance Record
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Cleaning Record
9.0 References
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WHO TRS guidelines
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EU GMP Annex 1 & Annex 8
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USFDA cGMP guidelines
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