| Operating And Cleaning Procedure Of Sampling Booth & Dispensing Booth |
| 1.0 OBJECTIVE: 1.1 To lay down the procedure for Operating and Cleaning procedure of Sampling booth and Dispensing booth. 2.0 SCOPE: 2.1 This procedure is applicable for the Operating And Cleaning Procedure Of Sampling Booth and dispensing booth. 3.0 RESPONSIBILITY: 3.1 Officer–Warehouse is responsible to supervise the compliance for the Operating And Cleaning Procedure Of Sampling Booth per this SOP. 3.2 Assistant- Quality Control shall be responsible for sampling the material at sampling booth under RLAF. 3.3 Asst. Store-Officer shall be responsible to dispense the material at Dispensing booth under RLAF. 4.0 ABBREVIATIONS 4.1 SOP : Standard Operating Procedure 4.2 IPQA : In-process Quality Assurance 4.3 BMR : Batch Manufacturing Record 4.4 LAF : Laminar Air Flow 4.5 SOP : Standard Operating Procedure. To read this SOP click here SOP for Reclassification, Quarantine, Intimation To Qc, Sampling And Approval / Rejection Of Raw Material. 5.0 PROCEDURE: 5.1 Operational Procedure(Operating And Cleaning Procedure Of Sampling Booth) 5.1.1 Before starting of operation, visually checks the cleaning of Dispensing & sampling booth area and display ‘CLEANED’ status duly signed by warehouse department. Inform IPQA for the verification of cleaning of area and RLAF. After clearance by IPQA person mention the status of the area on sign board outside the door. 5.1.2 Sampling booth & dispensing booth shall be started 10 minutes before starting sampling & dispensing the activities. 5.1.3 Switch ON the Mains and Light. 5.1.4 Check the magnahelic gauge reading, to meets the acceptance limits. 5.1.5 If the differential pressure is not meeting the specifications, do not perform Sampling or Dispensing operations and inform to Engineering Department. 5.1.6 Collect one container at a time from the air lock. 5.1.7 Ensure that all operation is within the safe working zone only. 5.1.8 Ensure the posture, while doing not to disturb the airflow pattern. 5.1.9 Carry out all the Operation by Standing in front of the drum / container and avoiding obstruction of airflow. 5.1.10 After sampling or dispensing, reseal the Containers. 5.1.11 After completion of sampling & dispensing transfer the material in designated place. 5.1.12 Display the status “TO BE CLEANED” on the area. 5.1.13 Record the sampling and Dispensing activities in “Sampling Booth Usage and cleaning Log” as per XXX and “Dispensing Booth Usage and cleaning Log” as per XXX. 5.2 Cleaning Procedure 5.2.1 Type A: For batch to batch changeover (Same product) – For Dispensing Booth/ inactive material change over – For Sampling Booth. 5.2.2.1 Mention the cleaning status of the area on sign board outside the door. 5.2.2.2 Remove all the material from the Sampling booth and Dispensing booth. 5.2.2.3 Switch ‘OFF’ the electrical supply of RLAF. 5.2.2.4 Switch OFF balance. 5.2.2.5 Dry Mopping the Dispensing and Sampling booth. 5.2.2.6 Record the Sampling booth usage and cleaning record as per XXX. 5.2.2.7 Record the Dispensing booth usage and cleaning record as per XXX. 5.2.2 Type B: During Product changeover – for Dispensing Booth/During Active material change over – for Sampling Booth 5.2.1.1 Mention the cleaning status on sign board outside the door. 5.2.1.2 Remove all the material from the Sampling booth and Dispensing booth. 5.2.1.3 Switch ‘OFF’ the electrical supply of RLAF. 5.2.1.4 Switch OFF balance. 5.2.1.5 Vacuum clean the area using vacuum cleaner & dry Mopping the Dispensing and Sampling booth. 5.2.1.6 Clean the area by 2.5% (e.g. 2.5 gm in 100 lit. potable water) Dettol and Savlon, solution with rotation. 5.2.1.7 Record the Sampling booth usage and cleaning record as per XXX. 5.2.1.8 Record the Dispensing booth usage and cleaning record as per XXX. 5.2.1.9 Display cleaned status duly by warehouse department, inform IPQA for the verification of cleaning. After clearance by IPQA mention the status of the area on sign board. 5.2.3 Frequency: 5.2.3.1 Type – “A”: During the batch to batch Change over (for same product) or after 24 hours. 5.2.3.2 Type – “B”: During the product changeover or after completion of consecutive 8 batches of same product or after one week (if booth not in use) |
