SOP for cleaning and operation of Carton Over Printing Machine

1.0 OBJECTIVE: To lay down a procedure for cleaning and operation of carton over printing machine.

2.0 SCOPE: This procedure is applicable for cleaning and operation of carton overprinting machine in production department at Pharmaceuticals.

3.0 RESPONSIBILITY
Operator, Officer, and Executive – Production Department
Manager – Production Department

4.0 DEFINITION(S)
NA

5.0 PROCEDURE: for Carton Over Printing Machine
5.1 Cleaning

5.1.1 Remove “ TO BE CLEANED “ label and affix “ UNDER CLEANING “ label on the machine as per SOP (Title: Status labeling in production department).

5.1.2 Ensure that the carton overprinting machine is switched OFF.

5.1.3 Remove the previous carton from belt of the machine.

5.1.4 Remove the previous stereos from the machine.

5.1.5 Dry clean the carton overprinting machine body and utility cables using a dry lint-free duster.

5.1.6 Ink is cleaned by a lint-free duster soaked with thinner.

5.1.7 Replace ‘UNDER CLEANING‘ status label with ‘CLEANED’ status label.

5.1.8 Record the cleaning activity in equipment usage log sheet as per SOP (Title: Making entries in equipment usage and cleaning log sheet).

5.2 Machine Setup and Operation

5.2.1 Ensure the cleanliness of the machine.

5.2.2 Take line clearance by production officer and QA officer.

5.2.3 Remove ‘CLEANED’ status label with ‘UNDER PROCESS‘ status label after line clearance.

5.2.4 Issue the required rubber stereo of the batch/product for overprinting.

5.2.5 Fix the stereo on the block with the help of double-sided adhesive tape.

5.2.6 Apply the ink on the ink pad.

5.2.7 Put ‘On’ the power supply of the machine.

5.2.8 Place one carton on the line so that the carton will push to the printing area.

5.2.9 Set the On delay pusher time, On delay printer time, Off delay printer time as per required to get a good printing quality on the carton.

5.2.10 Apply ink or thinner in between to get good printing quality.

5.2.11 First, take the impression on one carton to ensure the overprinting quality, if proper adjust the alignment of stereo.

5.2.12 Take impression on the carton. Overprinting on a carton should be clear and legible.

5.2.13 Get the first overprinted carton signed by production officer and approved by Q.A officer, and affix the specimen to the BPR. Enter the overprinting activity in the respective BPR.

5.2.14 After getting the approval from QA, start the online overprinting activity.

5.2.15 Enter the operation time in equipment usage log sheet.

5.2.16 After completion of activity, switch OFF the machine.

5.2.17 Affix the status of “TO BE CLEANED”.

6.0 ABBREVIATION(S)
SOP: Standard operating procedure
No. : Number
BPR: Batch Packing Record
QA: Quality Assurance

7.0 REFERENCES(S)
SOP: Status labeling in production department
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
9.3 Reference copy (s): Production department