In this post Standard Operating Procedure Cleaning and Operation of Sticker Labeling Machine in Pharmaceuticals is describe.
1.0 OBJECTIVE:
To lay down the procedure for Cleaning and Operation of Sticker Labelling Machine.
2.0 SCOPE:
This procedure is applicable for Cleaning and Operation of Sticker Labelling Machine in Liquid Orals.
3.0 RESPONSIBILITY:
Technical associate Production - for Execution
Officer/ Executive Production - for verification and implementation of SOP Head Production - shall ensure compliance of the SOP.
4.0 DEFINITION(S):
NA
5.0 PROCEDURE:
5.1 Cleaning
5. 1.1 Check the status “TO BE CLEANED” on equipment with details.
5.1.2 Carry out the following procedure at batch or product changeover.
5.1.2.1 Remove all Over printed Sticker labels and destroy them after reconciliation as per respective BPR.
5.1.2.2 Remove the unprinted label roll from the machine.
5.1.2.3 Remove the release paper roll from the unwinding roller.
5.1.2.4 Clean the unwinding rollers with IPA & with dry lint free cloth.
5.1.2.5 Clean all the sticky material from the label release plate with IPA.
5.1.2.6 Clean the sensor with dry cloth.
5.1.2.7 Clean the conveyor belt, bottle guide with wet cloth followed by lint free dry cloth.
5.1.2.8 Clean the wrapper round belt & bottle guide (Rubber) with wet lint free cloth & remove all the Sticky materials from there gently.
5.1.2.9 Wipe the SS machine covers with wet cloth followed by dry cloth.
5.1.2.10 Affix “CLEANED” label on the machine as per reference SOP.
5.1.2.11 Record the details of cleaning of sticker labeling machine in equipment usage log sheet as per reference SOP.
5.2 Machine set up and Operation:
5.2.1 Ensure that sticker labeling machine is cleaned.
5.2.2 Install the label roll on the roll stand.
5.2.3 Measure the length of single label by using a cm scale. Then measure the pre dispensing length i.e. the distance between two consecutive labels.
5.2.4 Adjust the Pre dispensing length between 5-12 mm.
5.2.5 Bottle separator separate one bottle from other and maintain the distance between the two consecutive bottles.
5.2.6 Bottle guide direct the bottle in a single direction.
5.2.7 Label sensor sense the label and help in the dispensing.
5.2.8 Adjust the height of the label by adjusting the roller and guides.
5.2.9 Adjust the tightness of sticker roll ribbon from dancing roll spring and from stainless steel tension strip.
5.2.10 Install the Printing unit (hot foil printer). Hot foil printing unit mounded on the rail between dispenser and label scanner with the help of clamping plate which is easily adjust on the rail for proper positioning on the label.
5.2.10.1 Open the air valve which is attached to the inlet of solenoid valve.
5.2.10.2 Stamping block consisting of alloy steel letters, get heated with electrical controlled by thermostat and temprature controller as set.
5.2.10.3 Normal temperature required for stamping is 125°C-130°C. it may vary between 125°C to 160°C depending of quality of foil.
5.2.11 PLC programmer and function:

5.2.11.1 ESC : Release
RUN : For Machine Run
Start : For conveyor
▲ : For increasing
▼ : For decreasing
◄ : for changing on left side
►: For changing on right side
MAN : Not applicable
F1 : Not applicable
5.2.11.2 ENT:
1. Label speed - 15 to 20 meter/ minute
2. Label length - It is measure as total length + gap between two label + 2 MM
3. Pre-dispensing - Normally 10 mm
4. Printer 1 time - Not applicable
5. Printer2 time - Not applicable
6. Label sensor - At 00
7. Reset label – ESC – then ENT - Reset total label- “N”- then press “ TOG” key and press – ENT – then ESC - then – RUN – it observe 0.0
5.2.12 Start the machine, put the heater on 10 minute to heat the stamping block.
5.2.13 Feed the coding programme as per product‘s record.
5.2.14 Now allow the bottle to sticker labeling machine from turn table
5.2.15 Press the ESC button then press RUN after pressing the RUN machine will start.
5.2.16 After the completion of operation, Switch ‘OFF’ electric supply.
5.2.17 Affix “TO BE CLEANED” label on the machine as per reference SOP.
5.2.18 Record the details of operation of sticker labeling machine in equipment usage log sheet as per reference SOP.
5.3 NOTE:
5.3.1 Ensure adequate oil level by reduction gear box.
5.3.2 Ensure air pressure in the unit is not less than 4 kg/cm²
5.3.3 Always be careful about the air supply pressure for better printing. if the air pressure is lower than set pressure, machine will be stopped.
5.3.4 Lubricate daily all moving parts with food grade oil when product is coming in contact and grease for closed parts.
6.0 ABBREVIATION (S):
SOP: Standard Operating Procedure. No. : Number
PLC : Programmable logic controller NA : Not applicable
7.0 REFERENCE(S):
SOP: Status labeling
SOP: Making entries in equipment usage and cleaning log sheet
8.0 ANNEXURE (S):
NIL
9.0 DISTRIBUTION:
9.1 Master Copy: Quality Assurance
9.2 Controlled Copy (S): Production department, Quality Assurance
9.3 Reference Copy (S): Production department