Table of Contents
1.0 OBJECTIVE:-
1.1 This SOP is the procedure for Cleaning And Operating Of Inspection Machine.
2.0 SCOPE of Cleaning And Operating Of Inspection Machine
2.1 To prevent cross contamination between products. To ensure error free operation of machine. This procedure is applicable for dividing, Cleaning And Operating Of Inspection Machine.
3.0 RESPONSIBILITY:-
3.1 Execution: Operator
3.2 Production Executive
4.0 ACCOUNTABILITY:
4.1 Head of Department.
5.0 Procedure:
5.1 Procedure for Cleaning And Operating Of Inspection Machine
5.1.1 Remove “TO BE CLEANED” tag from the machine.
5.1.2 Turn “OFF” the electric supply.
5.1.3 Divide the following part and take it to the washing area. S.S. feed hopper & Tablet S.S. outlet in production area.
5.1.4 Wash the above parts using tap water (Use nylon brush if require to clean and to remove adhered sticky mass.
5.1.5 Finally Rinse it with D.M. Water/purified water and then with 70% I.P.A with allow to dry it and arrange in it on Inspection in reverse order of dismantling.
5.1.6 Clean `Material receiving and delivering assembly’ in the same sequences as above.
5.1.7 Remove the dust from inspection machine belt and clean the belt with lint free cloth dipped in D.M .water & then with 70 % I.P.A & allow it to dry.
5.1.8 Clean surrounding area of the machine as per.
5.1.9 Record the details in equipment cleaning record.
5.1.10 Affix a “CLEANED” tag on the machine.
5.1.11 SAFETY: Protect Motor from contact of water.
5.1.12 FREQUENCY: Product to product changes over & batch to batch after cleaning in production area.
5.2 Procedure for Operation.
5.2.1 Cleaning the machine and surrounding area as per respective Standard operating procedure and set the according to the product which is being Inspection Machine.
5.2.2 Affix the stage label of Cleaning And Operating Of Inspection Machine.
5.2.3 Take Line clearance from QA department as per respective SOP.
5.2.4 Transfer the drum of tablets (Compressed / Coated) from unchecked quarantine to inspection are using trolley.
5.2.5 Keeped all the drums/containers of the batch on a pellets. Open one drum and load the tablet into the hopper, remove the container label of empty drum and keep it on a separate pellet to load the inspected tablets in production areas.
5.2.6 Switch “ON” the mains, Switch “ON” the tube light, adjust the flow of tablets on the conveyer belts from hopper by means of flow control plate and intensity of vibration with the validated speed as indicated on the label.
5.2.7 Pick-up the defective tablets as per criteria for defective tablets described in respective SOP
5.2.8 On LHS one person will check the tablet from one side and then tablets will get inverted and moves to the person seated on RHS for checking on another side.
5.2.9 Collect the good tablets in clean plastic container lined with double poly bag use the double poly
5.2.10 Bags in case of hygroscopic products.
5.2.11 Use foot break to stop the belt when required.
5.2.12 Replace the filled drums/containers by empty drum and keep the filled drum aside on the pellets. Affix container label on each containers.
5.2.13 Covered the tablets container with lid and keep it on a pallets.
5.2.14 After completion of inspection collect the rejected tablets from the rejection box in polythene bag with proper label. Affix “Rejected” label if the tablets are to be rejected and destroyed. Affix “Recoverable Reject” label if the tablets are to be recovered.
5.2.15 Weigh the container on calibrated electronic platform balance and note it on to the container label and in the BPR
5.2.16 After completion of inspection, Switch “OFF” the tube light, vibrator and mains.
5.2.17 Affix a “TO BE CLEANED” tag on machine.
5.3 PRECAUTION of Cleaning And Operating Of Inspection Machine
5.3.1 Do not operate the machine in reverse direction.
5.3.2 Do not operate the machine without loading the tablet into the hopper
5.3.3 Check the Cleanliness and proper oil-lubrication before starting the machine.
6.0 ABBREVIATIONS of Cleaning And Operating Of Inspection Machine
6.1 EFF. : Effective
6.2 SOP : Standard Operating Procedure
6.3 Mfg. : Manufacturing