Cleaning and Operation of Carton Overprinting machine (Numach Code)

In this post Standard Operating Procedure Cleaning and Operation of Carton Overprinting machine (Numach Code) in Pharmaceuticals is describe.

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.

3.0 RESPONSIBILITY:

Technical Associate- For Cleaning and Operation.

Officer/Executive Production - For Supervision.

Head Production -To ensure compliance of the SOP.

4.0 DEFINITION(S):

5.0 PROCEDURE:

5.1 Cleaning

5.1.1 Ensure that the Carton Overprinting machine is switched ‘‘OFF’’.

5.1.2 Remove the previous carton from the machine.

5.1.3 Remove the previous stereos from the machine.

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

5.1.5 Ink shall be cleaned from the roller by lint free duster soaked with thinner.

5.1.6 Put ‘‘CLEANED’’ status label having Unit, Department, Equipment name, Cleaned by, Checked by Production Officer, Date and finally verified by Quality Assurance (QA) as per reference SOP.

5.1.7 Record the cleaning activity in equipment usage log sheet as per SOP.

5.2 Machine set up and Operation:

5.2.1 Ensure the cleanliness of the machine.

5.2.2 Remove ‘CLEANED’ status label with ‘UNDER PROCESS ‘status label after line clearance as per reference SOP.

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

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

5.2.5 Apply the ink on the ink pad.

5.2.6 Put ‘‘ON’’ the power supply of the machine.

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

5.2.8 Set the stereo block as per required to get a good printing quality on the carton with in the space given for the printing on the carton.

5.2.9 Apply ink or thinner on the roller for printing of carton.

5.2.10 First take the impression on one carton to ensure the overprinting quality, it should be clear and legible.

5.2.11 Get the first overprinted carton signed by production officer and approved by QA Officer and affix the specimen to the BPR. Enter the overprinting activity in the respective BPR.

5.2.12 After getting the approval from QA start the online overprinting activity.

5.2.13 Enter the operation time in equipment usage log sheet.

5.2.14 After completion of activity, switch ‘‘OFF’’ the machine.

5.2.15 Affix the status of “TO BE CLEANED”.

6.0 ABBREVIATION(S):

SOP : Standard operating procedure No. : Number

BPR : Batch Packing Record

7.0 REFERENCES(S):

SOP: Status labeling

SOP: Making entries in equipment usage and cleaning log sheet

8.0 ANNEXURE (s):

Nil