Standard Operating Procedure for Ink Preparation and Replacement

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide detailed guidelines for the preparation and replacement of ink used in the printing process. This SOP ensures that the ink is of the required quality and consistency to produce clear and legible prints on various pharmaceutical packaging materials.

2. Scope

This SOP applies to all personnel involved in ink preparation and replacement, including operators, technicians, and quality assurance
staff, in the printing department.

3. Responsibilities

• Ink Preparer: Responsible for preparing the ink according to the defined formula and ensuring it meets the required quality standards.
• Printing Operator: Responsible for replacing ink in the printing equipment as needed and following the proper procedures for ink changeover.
• Quality Assurance (QA) Staff: Responsible for conducting regular checks on the prepared ink to verify its quality and consistency.

4. Procedure

4.1 Ink Preparation:

• Review the ink preparation formula and gather all the required raw materials, including pigments, binders, solvents, and additives, as per the approved batch record.
• Ensure that all equipment to be used for ink preparation, such as mixing vessels, stirrers, and measuring devices, are clean and sanitized before use.
• Weigh and measure the raw materials precisely according to the specified quantities in the formula.
• Gradually add the raw materials into the mixing vessel following the specified sequence, and use a suitable mixing method (e.g., stirring or milling) to obtain a homogenous ink mixture.
• Once the ink is prepared, transfer it into approved containers, label them with the necessary information (e.g., ink name, batch number, preparation date), and submit a sample to the Quality Control (QC) department for testing.
• Only use the ink for printing once it has been approved by QC and meets the required specifications.

4.2 Ink Replacement:

• Before replacing the ink in the printing equipment, ensure that the current job is completed or stopped appropriately.
• Thoroughly clean the ink reservoir and other ink pathways using the approved cleaning procedure to prevent any contamination or color mixing.
• Carefully pour the prepared ink into the cleaned reservoir, taking care not to spill or waste any ink.
• Start the printing equipment and perform a test run to check the print quality and confirm that the new ink is performing as expected.
• If any issues are detected during the test run, stop the printing process, investigate the root cause, and take corrective actions as
  necessary.
• Document the ink replacement activity, including the batch number of the new ink and the start and end times of the ink replacement process.

5. Abbreviations

SOP: Standard Operating Procedure
QC: Quality Control

6. Documents

The following documents are relevant to this SOP:

• Ink Preparation Formula and Batch Record
• Ink Cleaning and Sanitization Procedure
• Ink Changeover Log

7. References

No specific external references are required for this SOP as it is based on internal company procedures and industry best practices.

8. SOP Version

This is version 1.0 of the SOP for Ink Preparation and Replacement, effective as of [Insert Date].