In this post Standard Operating Procedure of Cleaning and Operation of Hot Melt Gum Dispenser in pharmaceuticals is describe.
1.0 OBJECTIVE:
1.1 To lay down a procedure for Cleaning and Operation of Hot Melt Gum Dispenser.
2.0 SCOPE:
2.1 This procedure is applicable for secondary packaging.
3.0 RESPONSIBILITY:
3.1 Technical associate : Cleaning and Operation of Hot Melt Gum Dispenser.
3.2 Officer / Executive : Supervision of Cleaning and Operation.
3.3 HOD - Production Department :Compliance of SOP
4.0 DEFINITION:
4.1 NA
5.0 PROCEDURE:
5.1 CLEANING:
5.1.1 Clean Electrical cable / Pipes / Outside body with clean dry lint free duster after completion of batch.
5.1.2 After completion of total bulk packing activity or once in six month or whenever required clean the Gum Tank / Gun with Paraffin wax and Vacuum drum by using Hot air gun with the assistance of engineering team.
5.1.3 Operate the melter normally, until the tank gets emptied.
5.1.4 Press the Pump key to stop the pump.
5.1.5 Allow the melter to heat or cool to the temperature.
5.1.6 Wipe off the residual hot melt from the inside of tank.
5.1.7 Remove the tank strainer, clean it with an appropriate flushing material and then reinstall it.
5.1.8 Add the appropriate quantity of flushing material to the tank.
5.1.9 Disconnect a hose from a gun and direct the hose into a waste container.
5.1.10 Press the pump key to start the pump.
5.1.11 When the tank is emptied, stop the pump.
5.1.12 Reconnect the disconnected hose to its gun.
5.1.13 Restore the system to normal operation.
5.2 Precaution:
5.2.1 Use Safety goggles and heat resistant hand gloves during gum tank cleaning.
5.2.2 Do not Over Feed Gum Tank.
5.2.3 Keep Machine on stand -by position whenever idle.
5.2.4 Politely scrub out the gum from tank to avoid scratches in tank.
5.3 OPERATION
5.3.1 Check the cleanliness of the hot melt gum dispenser.
5.3.2 Switch on the mains from control panel then Plug In the power code.
5.3.3 Open the Gum Tank and put the Gum cake in to the tank ensure that gum tank should not over flow. Close the tank lid.
5.3.4 Set the Temperature For Hot Glue Gum Machine (i.e. Gum Tank / Pipe / Gun) from 150°C -200°C by pressing heating switch for approx. 3 second till LED light Blinking, Then Set the temperature as per limit given in BPR. To decrease temperature press “▼” button and to increase Temperature press “▲” button.
5.3.5 Wait till Temperature achieved up to set point green light will blink on Gun Tank / Pipe / Gun Symbol.
5.3.6 Start the Vacuum pump by pressing key of vacuum motor present on front site of panel.
5.3.7 Now switch on main power supply of Leaflet Outserter Machine. Enter the password. Screen will open with some icon.
5.3.8 Select Parameter icon. Enter password. Select ‘glue dispenser’ ON/OFF.
5.3.9 To adjust the position of glue dispensing, change the value of ‘glue dispense position’.
5.3.10 To change the quantity of glue, select ‘glue quantity’ and change the value.
5.3.11 Check physically quantity and position of glue on bottle closure.
5.3.12 After operation completion, switch off the mains.
5.3.13 Clean the machine with dry lint free cloth.
5.3.14 If Machine is idle then keep it on stand-by position by pressing stand by button (Ensure green light glowing).
6.0 ABBREVATION (S):
6.1 SOP: Standard Operating Procedure
6.2 LED: Light Emitting Diodes
6.3 BPR: Batch Packaging Record
7.0 REFFERENCES (S):
7.1 SOP: Making entries in equipment usage and cleaning log sheet.
8.0 ANNEXURE (S):
8.1 NA
9.0 DISTRIBUTION:
9.1 Master copy : Quality Assurance
9.2 Controlled Copy (S): Production department (03), Quality Assurance (01)
9.3 Reference copy (S): Production department (04)
10.0 REVISION HISTORY: