Cross Contamination Control SOP

1.0 PURPOSE

1.1 To ensure that the production area, machine and surrounding work area are free from previous product, material, documents, labels and other unwanted items before starting a new job, thereby preventing mix-ups and cross-contamination.

2.0 SCOPE

2.1 Applicable to all production areas including Printing, Lamination, Slitting, Inspection and Packing sections.

3.0 REFERENCE(S) & ATTACHMENTS

3.1 References

3.1.1 In-house

3.2 Attachments

3.2.1 Nil

4.0 RESPONSIBILITY

4.1 Operator: Clean the machine and surrounding area and remove previous job materials.

4.2 Production Supervisor: Verify line clearance.

4.3 QA and QC Person: Perform final inspection and approve line clearance before production start.

5.0 DISTRIBUTION

5.1 Quality Control

5.2 Production

6.0 DEFINITION(S) & ABBREVIATION(S)

6.1 Definitions

6.1.1 Cross-Contamination: the unintended transfer of ink, coating, adhesive, dust, oil or foreign particles from one material, process or printing station to another, which can affect print quality and product safety. This is especially critical in pharmaceutical, food and medical packaging.

6.1.2 Line Clearance & Mix-up Control: Line Clearance is a documented procedure carried out before starting a new batch or job to ensure that all materials, documents, equipment and residues from the previous job have been completely removed. This prevents cross-contamination, mix-ups and printing errors.

6.2 Abbreviations

6.2.1 Nil

7.0 PROCEDURE

7.1 Stop the previous production and remove all materials.

7.2 Clean the machine, cylinders, doctor blades, ink trays, pumps and work area.

7.3 Remove all previous labels and documents.

7.4 Verify the correct cylinder, artwork, substrate, ink and job card.

7.5 Ensure no leftover printed rolls, ink or waste remain.

7.6 Conduct a visual inspection of the entire printing line.

7.7 QA/QC or an authorized person verifies and signs the line clearance record.

7.8 Start the new job only after line clearance approval.

7.9 Acceptance Criteria

7.9.1 No materials from the previous job are present.

7.9.2 Equipment is clean and dry.

7.9.3 Correct materials and documents are available.

7.9.4 No visible ink, dust, adhesive or foreign particles.

7.9.5 QA / Production approval shall be done before production starts.

8.0 REVISION HISTORY:

+----------------+----------------+----------------+----------------+----------------+----------------+ | Revision No. | 00 | Effective | | CC No. | | | | | Date | | | | +----------------+----------------+----------------+----------------+----------------+----------------+ | Details of revision: New SOP | +-----------------------------------------------------------------------------------------------------+