| Operating and Cleaning Of Two Head Tube Filling Machine |
1.0 OBJECTIVE: 1.1 To lay down a procedure for operation and cleaning of two head Tube filling machine. 2.0 SCOPE: 2.1 This procedure is applicable for formulation plant. 3.0 RESPONSIBILITY: 3.1 Trained Operators are responsible for operating and cleaning of the machine as per the procedure mentioned in this SOP. 3.2 Production Officer / Supervisor are responsible for implementation of the procedure as per this SOP. 3.3 Production Head is responsible for compliance of procedure as per this SOP. 4.0 PROCEDURE: 4.1 Cleaning Procedure 4.1.1 Type – “A”- For batch to batch changeover (Same product) 4.1.1.1 Mention the area under cleaning status on sign board outside the area. 4.1.1.2 Switch ‘OFF’ the electric supply from mains. 4.1.1.3 Remove previous batch material from the filling area. 4.1.1.4 Clean the nozzles properly with soft water. 4.1.1.5 Dry Mopping the filling area. 4.1.1.6 Record the cleaning details in Machine Log Book as XXX. 4.1.2 Type – “B” During Product Change Over: 4.1.2.1 Mention the area under cleaning status on sign board outside the area. 4.1.2.2 Switch ‘OFF’ the electrical supply from mains. 4.1.2.3 Protect electrical parts from the water contact. 4.1.2.4 Remove the previous status label and affix ‘TO BE CLEANED’ label, with the name of equipment, Equipment No, Previous product, Batch No. & Date with sign. 4.1.2.5 Dismantle the hopper, piston, cylinder and nozzle and take them to washing area. 4.1.2.6 Wash the dismantled parts with potable water until to remove the traces of foam. Clean internal surface by using sponge brush. 4.1.2.7 Finally rinse the change parts with hot purified water and dry with air. 4.1.2.8 Wipe all external surfaces using dry lint free cloth. 4.1.2.9 Keep change parts with proper labeling in filling area after washing. 4.1.2.10 Assemble the dismantle parts to the filling machine under supervision. 4.1.2.11 Inform IPQA to collect the wash water sample through In-process Analytical Request / Report. 4.1.2.12 After Receiving wash water analysis report compliance. 4.1.2.13 Affix a ‘Cleaned’ label duly filled and signed. 4.1.3 Record the cleaning details in Machine Log Book XXX. 4.1.4 Frequency: 4.1.4.1 Type A: During the batch to batch Change over (for same product) or after 24 hours. 4.1.4.2 Type B:During the product changeover or after completion of consecutive 5 batches of same product or after 72 hours (if machine not in use). To read this sop Click here SOP for Cleaning, Operation and usage of dynamic pass box. 4.2 Operating procedure: 4.2.1 Before starting of operation, ensure that the cleaning of area and equipment/machine with ‘CLEANED’ label duly filled and signed by production department. 4.2.2 Inform IPQA for the verification of cleaning of area and equipment/machine. After clearance by IPQA person, remove the cleaned label and attach in BMR. Also mention the status of the area on sign board outside the door. 4.2.3 Affix a ‘BATCH IN PROCESS’ label duly filled and signed as per SOP Annexure I of XXX “Labeling” 4.2.4 Switch “ON” the power supply from mains. 4.2.5 Switch “ON” the Air supply; it should not be more than 6.0 kg. 4.2.6 Machine set Auto or Manual mode. 4.3 Manual Mode Operation 4.3.1 For manual on, inch press green color button. 4.3.2 Vacuum pump “ON” by turn black color (ON/OFF) button. 4.3.3 Cassey motor “ON” by turn black color (ON/OFF) button. 4.3.4 In case of metal tube filling only air open. 4.3.5 In case of lami tube filling. 4.3.6 Blower “ON” by press green color button. 4.3.7 Heating “ON” and set temp. (300°c to 315°c) as per BMR. 4.3.8 Cap tightening button “ON” by turn black color cap tightening (ON/OFF) button. 4.3.9 Jacket hopper heater “ON” only manually and set temperature as per require. 4.3.10 Lubrication pumps “ON” for lubrication of machine continuously and use only 60 no machine oil use. 4.3.11 Door bypass position: 4.3.12 When “ON” mode: Machine run only when all door is closed. 4.3.13 When “OFF” mode: Machine stop if any door are open. 4.3.14 Two heater work for double head filling machine “ON” by green color button and “OFF” by red color button. 4.3.15 No Tube No Fill process occurs due to presence of two bottle sensor. 4.3.16 Hopper stirrer continuously runs with speed. 4.3.17 Mode button black color use for RUN/INCH of machine. 4.4 Auto Mode Operation 4.4.1 All parameter set automatically. 4.4.2 Cassette motor for tube adjustment should be “OFF” at the time of PLC Mode operation. 4.4.3 Vacuum pump should be “OFF” at the time of PLC mode operation. 4.4.4 At the time of emergency push red color button to stop all machine function at once. 4.4.5 Position stop button (red color) press to stop machine at the position of work 4.4.6 Record the Operating details in Machine. 5.0 ABBREVIATIONS 5.1 SS : Stainless Steel 5.2 SOP : Standard Operating Procedure 5.3 IPQA : In – Process Quality Assurance 5.4 Temp : Temperature 5.5 PLC : Programmable Logic Control |
