STANDARD OPERATING PROCEDURE

Title: Operation & Cleaning of Continuous Ink Jet (CIJ) Printer 8800

Doc No: PR/SA/OP/097 Version No: 1 Page No: 1 of 3

Effective Date: 03/01/2023 Next Review Date: 02/01/2026

1. Purpose:
To describe a stepwise procedure for the Operation & Cleaning of Continuous Ink jet (CIJ) printer
8800.

2. Scope:
This SOP is applicable for CIJ Printer 8800 installed at the BFS Filling Area for
Ampoules/Respules overprinting of Hudson Pharma (Pvt.) Limited.

3. Responsibility:
3.1. Operator is responsible for the executing of this SOP.
3.2. Production officer is responsible for following this SOP.
3.3. QAO officer is responsible for verification.
3.4. Manager Production is responsible for SOP implementation.
3.5. QAM / Designee are responsible for audit compliance.

4. Procedure:
4.1 Creation of a new message Continuous ink jet printer:
4.1.1 Check and ensure that the Continuous Ink Jet (CIJ) Printer is cleaned.
4.1.2 To create and edit a production schedule, do the following:
4.1.3 From the Production Schedule Store screen, touch the Create button to display the
Production Schedule Editor screen.
4.1.4 Touch the Message List button to display the Select Message screen where you can
select the first message of the production schedule.
4.1.5 Select the required message (for example, ‘Message_1’). The Production Schedule
Message Entry screen is displayed.
4.1.6 To edit the properties of the production schedule, Select the field “Functions” and make a
required printing message, select the font name “UNIVERSAL”, font size ‘7’ & Select Bold
factor ‘x1’ for Ampoules/respules overprinting.
4.1.7 Use the Edit button on the Production Schedule Store screen to edit a production
schedule.
4.1.8 Select your required options, and then touch the Save button. Enter a name for the
production schedule, and then touch the Enter button to return to the Production
Schedule Store screen with the production schedule displayed.
4.1.9 Select the line direction that you require. The picture of the production line on the screen
changes to show the line direction that is selected.

4.2 Printing of message:

Prepared by Reviewed by Reviewed by Approved by

Executive Production Manager Production Deputy Manager QA Head of Quality Operations

 STANDARD OPERATING PROCEDURE

Title: Operation & Cleaning of Continuous Ink Jet (CIJ) Printer 8800

Doc No: PR/SA/OP/097 Version No: 1 Page No: 2 of 3

Effective Date: 03/01/2023 Next Review Date: 02/01/2026

4.2.1 Select the Message from the Production schedule home screen.
4.2.2 Now Click on the Start Printing button to start the print.
4.2.3 Overprint the required Ampoules/respules.
4.2.4 The 1st printed Ampoules/respules must be checked and signed by the production officer
and verified by Q.A officer.
4.2.5. After verification from Q.A officers start the overprinting on Ampoules/respules.
4.2.6 Continuously check the batch information and overprinting quality throughout the Filling
operation.
4.2.7 Step#4.2.5 should be repeated at the start of a shift operation and after a major
maintenance work on the CIJ Printer 8800.
4.2.9 After completion of overprinting, switch “OFF” the printer.
4.2.10 Always check the status of the ink before and after every use.

4.3. Cleaning:
Use a clean, soft, lint-free cloth and cleaning solution to clean the touch screen, when the
printer is in turned OFF Position.
4.3.1. Frequency:
● Before and after the operation or Whenever required.
● Inspect the printhead once a week for dried ink build‐up.
● After the maintenance work.

4.4 Precautions:
4.4.1. Only trained personnel are allowed to operate and to clean the CIJ printer 8800.
4.4.2. In case of any incident, immediately inform the area supervisor.
4.4.3. Prevent the CIJ Printer from water.
4.4.4. Shut down & turn off the CIJ Printer after the completion of overprinting.
4.4.5. Turn off the mains electrical supply and disconnect the electrical supply cable of the
printer.
4.4.6. Remove the printhead cover tube.
4.4.7. Avoid unnecessary talking during overprinting.

5. Glossary / Abbreviations:
QAM : Quality Assurance Manager.
CIJ : Continuous Ink Jet Printer
Prepared by Reviewed by Reviewed by Approved by

Executive Production Manager Production Deputy Manager QA Head of Quality Operations

 STANDARD OPERATING PROCEDURE

Title: Operation & Cleaning of Continuous Ink Jet (CIJ) Printer 8800

Doc No: PR/SA/OP/097 Version No: 1 Page No: 3 of 3

Effective Date: 03/01/2023 Next Review Date: 02/01/2026

6. Reference:
Operating manual of Continuous Ink Jet (CIJ) Printer 8800.

7. Distribution list:
i. Manager Production.
ii. Section Incharge.
iii. QA Master File.

8. History:

V/N Date Change Initiator Description of Change

1. 03/01/2023 Executive Production New SOP.

9. Annexure:
Log book for Operation & Cleaning of Continuous Ink Jet (CIJ) Printer 8800.

Prepared by Reviewed by Reviewed by Approved by

Executive Production Manager Production Deputy Manager QA Head of Quality Operations

 ANNEXURE I

Title: Log book for Operation & Cleaning of Continuous Ink Jet (CIJ) Printer 8800

Doc No: PR/SA/OP/095-A Version No: 1 Page No: 1 of 1

Effective Date: 03/01/2023 Next Review Date: 02/01/2026

Start Stop Checked by Verified by

Date Name of Product Batch No. Cleaned by Operated by Remarks
Time Time (Prod.) (QAO)

Prepared by Reviewed by Reviewed by Approved by

Executive Production Manager Production Deputy Manager QA Head of Quality Operations