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1.0 OBJECTIVE
To describe the procedure for operation, cleaning and maintenance of the sampling booth.
2.0 SCOPE
This procedure is applicable for the operation, cleaning and maintenance of sampling booth located in warehouse and dedicated for sampling of materials.
3.0 RESPONSIBILITY
3.1 QC Officer shall carry out the day to day operational activity during sampling as per the procedure described in this SOP.
3.2 Warehouse Officer shall ensure the cleaning of the sampling booth and RLAF work stations after completion of every sampling activity.
3.3 Engineering Officer shall carryout the activity related to routine maintenance of the sampling booth.
3.4 Overall responsibility for training, implementation & follow-up with the QC Manager or his/her designee.
4.0 ACCOUNTABILITY
4.1 Executive Director, Quality.
5.0 PRECAUTIONS
5.1 Before entering into the sampling booth, ensure to follow the entry procedure described under “Entry into and exit from Sampling area” in SOP WH002.
5.2 Undue turbulence inside the RLAFs of the sampling booth should be avoided.
5.3 If the pressure differential on Magnehelic gauges of medium filter (bag filter) is found less than 0.1 inch or more than 1.0 inch of water, and HEPA filter is found less than 0.2 inch or more than 1.5 inch of water, intimate this immediately to Engineering Department and do not start operation.
5.4 Ensure all gauges and balances under use are well within valid period of calibration.
5.5 Before starting cleaning of the RLAFs, ensure that the electrical supply is put “OFF” (Stopped).
5.6 Before pressing “Start” button switch of the RLAFs, ensure that the Isolator, fan, tube light switches are “ON”.
5.7 Make sure that the status labels (with details information) are always attached on the RLAFs.
6.0 PROCEDURE
6.1 General Information
6.1.1 The sampling booth under warehouse consists of two separate RLAF stations which are operated separately. However, the technical specifications of both the RLAF stations are same.
6.1.2 Both the RLAF stations can be used simultaneously or separately based on requirement.
6.2 Operational Procedure
6.2.1 Before entering into the sampling booth, QC officer shall collect the line clearance from the warehouse supervisor for its cleanliness.
6.2.2 Enter into the sampling booth through the change room (Man Entry) crossing the step over bench with proper precaution as per procedure.
6.2.3 Check the cleaning status of the sampling booth and the RLAF work station and sign in the cleaned label under IPQA/QC.
6.2.4 If the cleaning status is satisfactory, switch ON the RLAF by pressing “Start” button of the RLAF and wait for 30 minutes.
6.2.5 Check and record the pressure differential reading of Bag filter manometer and HEPA filter in the “Sampling Record” (FRM No.: FWH/017) register.
6.2.6 If the pressure differential readings are within the limit, remove the “CLEANED” label and attach it with line clearance sheet. Attach a status label containing the material name and batch number of which sampling will be done on the RLAF.
6.2.7 Carry the material containers/bags/packs on pallets through the material entry inside warehouse to the sampling booth and bring them one by one under RLAF.
6.2.8 Complete the sampling of the materials as per sampling procedure.
6.2.9 Press “Stop” button switch of the RLAF after completion of the sampling activity. Affix the status label “ To be cleaned” (FRM No. FPM/003) on the used RLAF.
6.2.10 Record the details of RLAF usage in to the “Sampling Record” (FRM No.: FWH/017).
6.3 Cleaning of Sampling Booth & RLAF stations
6.3.1 The cleaning activities of the sampling booth should be started from the inside of the RLAF. After cleaning the inside of the RLAF, the surrounding area (i.e. The room) to be cleaned.
6.3.2 Immediate after completion of sampling, remove all the remnants from the weighing balance (Platform/display unit/stand) and surrounding area.
6.3.3 Previous status label is to be dispose off and residue of the previous material is to be removed.
6.3.4 Ceiling and light fixtures are to be cleaned.
6.3.5 Panels and top of the booth are to be cleaned.
6.3.6 PVC curtain strips are to be cleaned.
6.3.7 Electrical switch board, cables and connectors are to be cleaned.
6.3.8 Sampling equipment or any other accessories is to be cleaned and dried.
6.3.9 Clean grills of filters by using vacuum cleaner.
6.3.10 Table, hygrometer along with holder and SOP holder are to be cleaned.
6.3.11 Door, glass door, glasses window and waste bin(s) are to be cleaned.
6.3.12 Clean inside panels of RLAF by using dry clean lint free cloth.
6.3.13 Spray 70% IPA solution on all inside surfaces and wipe out thoroughly with dry clean lint free cloth.
6.3.14 Clean the floor surfaces and surrounding area as per housekeeping of warehouse procedure (SOP No.: WH/004).
6.3.15 Ensure by visual inspection for proper cleanliness of the RLAF workstation. On satisfactory cleaning, remove the “To Be Cleaned” label and affix the label “CLEANED” (FRM No.: FQC/639) (Annexure-II), with proper input and signing. The warehouse supervisor shall check the cleaning status and sign in the cleaned label.
6.3.16 The cleaner shall full up the “Area & Equipment Cleaning Checklist of Sampling booth” (FRM No.: FQC/682-00; Annexure-III) and sign which will be checked by warehouse supervisor (Officer) and finally the checklist will be approved by QC officer.
6.4 Cleaning frequency
6.4.1 After sampling of each material.
6.4.2 If cleaned RLAF remains unused for more than 3 days, re-clean the RLAF before use.
6.5 Maintenance of the RLAF
6.5.1 Routine maintenance of the RLAF (including cleaning of the RLAF Pre-filters) shall be done by the Engineering Department as per the approved schedule and should be recorded
