Cleaning and Operation of Carton Overprinting Machine (NIMACH)

In this post Standard Operating Procedure Cleaning and Operation of Carton Overprinting Machine (NIMACH) in Pharmaceuticals is describe.

1.0    OBJECTIVE:

To lay down a procedure for Cleaning and Operation of Carton Overprinting Machine.

2.0    SCOPE:

This procedure is applicable to the Cleaning and Operation of Carton Overprinting Machine in Production area.

3.0    RESPONSIBILITY:

Technical associate  : Cleaning and Operation

Officer and Executive : Supervision

Head Production   : SOP compliance

4.0    DEFINITION (S):

NA

5.0    PROCEDURE:

5.1    CLEANING

5.1.1   Affix “TO BE CLEANED” label on the machine.

5.1.2    Record the cleaning start time in equipment usage log as per SOP.

5.1.3   Ensure that the carton-overprinting machine is switched OFF.

5.1.4   Remove the previous carton and label from the machine.

5.1.5   Removed the previous stereos from the machine.

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

5.1.7   Clean the ink by lint free duster soaked with thinner.

5.1.8   Replace “TO BE CLEANED”” status label with “CLEANED” label.

5.1.9   Finally clean the area as per SOP.

5.1.10   Record the cleaning end time in equipment usage log as per SOP.

5.4    OPERATION:

5.4.1   Ensure the cleanliness of the machine.

5.4.2   Take line clearance by production officer and QA officer.

5.4.3   Removed ‘CLEANED’ status label with ‘UNDER PROCESS ‘status label after line clearance.

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

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

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

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

5.4.8   Apply ink on ink- roller to get good printing quality.

5.4.9    First take the impression on one carton to ensure the proper alignment of stereo.

5.4.10   After setting of the stereo take the first proof which should be clear and legible.

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

5.4.12   After getting the approval start the overprinting activity.

5.4.13   Enter the operation time in equipment usage log sheet as per SOP.

6.0    ABBREVIATION (S):

QA  : Quality Assurance BPR : Batch Packing Record

SOP : Standard Operating Procedure

7.0    RERERENCE (S):

SOP: Making entries in equipment usage and cleaning log sheet. SOP: Cleaning of Production Area.

8.0    ANNEXURE (S):

Nil

9.0    DISTRIBUTION:

Master Copy    : Quality Assurance

Controlled Copy (S): Production Department, Quality Assurance

Reference Copy (S) : Production Department